0% found this document useful (0 votes)

599 views408 pages

SDTM and SDTMIG Conformance Rules v1.1

The document contains rules for SDTM IG (Study Data Tabulation Model Implementation Guide) version 3.2 and 3.3. Each rule lists an ID, the applicable class, domain, and variable. There are over 100 rules listed pertaining to different domains like AE, DS, DV, EX, and variables within those domains.

Uploaded by

Pavan Binigeri

We take content rights seriously. If you suspect this is your content, claim it here.

Available Formats

Download as XLSX, PDF, TXT or read online on Scribd

0% found this document useful (0 votes)

599 views408 pages

SDTM and SDTMIG Conformance Rules v1.1

Uploaded by

Pavan Binigeri

We take content rights seriously. If you suspect this is your content, claim it here.

Available Formats

Download as XLSX, PDF, TXT or read online on Scribd

You are on page 1/ 408

SDTM IG Rule

Rule ID Version Version Class Domain Variable

CG0001 3.2 1 ALL ALL DOMAIN

CG0001 3.3 1 ALL ALL DOMAIN

CG0002 3.2 1 ALL ALL --DUR

CG0002 3.3 1 ALL ALL --DUR

CG0006 3.2 2 ALL ALL --DY

CG0006 3.3 1 ALL ALL --DY

CG0007 3.2 1 ALL ALL --DY

CG0007 3.3 1 ALL ALL --DY

CG0008 3.2 1 ALL ALL --ELTM

CG0008 3.3 1 ALL ALL --ELTM

CG0009 3.2 1 ALL ALL EPOCH

CG0009 3.3 1 ALL ALL EPOCH

CG0010 3.2 1 ALL ALL GEN

CG0010 3.3 1 ALL ALL GEN

CG0011 3.2 1 ALL ALL GEN

CG0011 3.3 1 ALL ALL GEN

CG0012 3.2 1 ALL ALL GEN

CG0012 3.3 1 ALL ALL GEN

CG0013 3.2 1 ALL ALL GEN

CG0013 3.3 1 ALL ALL GEN

CG0014 3.2 1 ALL ALL GEN

CG0014 3.3 1 ALL ALL GEN

CG0015 3.2 1 ALL ALL GEN

CG0015 3.3 1 ALL ALL GEN

CG0016 3.2 1 ALL ALL GEN

CG0016 3.3 1 ALL ALL GEN

CG0017 3.2 1 ALL ALL GEN

CG0017 3.3 1 ALL ALL GEN

CG0018 3.2 1 ALL ALL GEN

CG0018 3.3 1 ALL ALL GEN

CG0019 3.2 1 ALL ALL GEN

CG0019 3.3 1 ALL ALL GEN

CG0020 3.2 1 ALL ALL GEN

CG0020 3.3 1 ALL ALL GEN

CG0021 3.2 1 ALL ALL GEN

CG0021 3.3 1 ALL ALL GEN

CG0022 3.2 1 ALL ALL --LNKGRP

CG0022 3.3 1 ALL ALL --LNKGRP

CG0024 3.2 1 ALL ALL --LNKID

CG0024 3.3 1 ALL ALL --LNKID

CG0026 3.2 1 ALL ALL --RFTDTC

CG0026 3.3 1 ALL ALL --RFTDTC
CG0027 3.2 1 ALL ALL --SCAT
CG0027 3.3 1 ALL ALL --SCAT

CG0028 3.2 1 ALL ALL --SEQ

CG0028 3.3 1 ALL ALL --SEQ

CG0029 3.2 1 ALL ALL USUBJID

CG0029 3.3 1 ALL ALL USUBJID

CG0031 3.2 1 ALL ALL VISIT

CG0031 3.3 1 ALL ALL VISIT

CG0032 3.2 1 ALL ALL VISIT

CG0032 3.3 1 ALL ALL VISIT

CG0033 3.2 1 ALL ALL VISIT

CG0033 3.3 1 ALL ALL VISIT

CG0034 3.2 1 ALL ALL VISIT

CG0034 3.3 1 ALL ALL VISIT

CG0035 3.2 1 ALL ALL VISITNUM

CG0035 3.3 1 ALL ALL VISITNUM

CG0037 3.2 1 EVT NOT(DS, DV, HO) --BDSYCD

CG0037 3.3 1 EVT NOT(DS, DV, HO) --BDSYCD

CG0039 3.2 1 EVT NOT(DS, DV, HO) --BODSYS

CG0039 3.3 1 EVT NOT(DS, DV, HO) --BODSYS

CG0040 3.2 1 EVT AE AEOCCUR

CG0040 3.3 1 EVT AE AEOCCUR

CG0041 3.2 1 EVT AE AESER

CG0041 3.3 1 EVT AE AESER

CG0042 3.2 1 EVT AE AESER

CG0042 3.3 1 EVT AE AESER

CG0043 3.2 1 EVT AE AESMIE

CG0043 3.3 1 EVT AE AESMIE

CG0044 3.2 1 EVT AE AESTAT

CG0044 3.3 1 EVT AE AESTAT

CG0045 3.2 1 ALL ALL --ENRTPT

CG0045 3.3 1 ALL ALL --ENRTPT

CG0046 3.2 1 ALL ALL --ENTPT

CG0046 3.3 1 ALL ALL --ENTPT

CG0047 3.2 1 EVT ALL --MODIFY

CG0047 3.3 1 EVT ALL --MODIFY

CG0049 3.2 1 EVT ALL --PTCD

CG0049 3.3 1 EVT ALL --PTCD

CG0050 3.2 1 EVT ALL --PTCD
CG0050 3.3 1 EVT ALL --PTCD

CG0053 3.2 1 EVT, INT NOT(DS, DV, EX) --REASND

CG0053 3.3 1 EVT, INT NOT(DS, DV, EX) --REASND

CG0056 3.2 1 EVT, INT NOT(DS, DV, EX) --STAT

CG0056 3.3 1 EVT, INT NOT(DS, DV, EX) --STAT

CG0057 3.2 1 ALL ALL --ENRTPT

CG0057 3.3 1 ALL ALL --ENRTPT

CG0058 3.2 1 ALL ALL --ENTPT

CG0058 3.3 1 ALL ALL --ENTPT

CG0059 3.2 1 ALL ALL --STRTPT

CG0059 3.3 1 ALL ALL --STRTPT

CG0060 3.2 1 ALL ALL --STRTPT

CG0060 3.3 1 ALL ALL --STRTPT

CG0061 3.2 1 ALL ALL --STTPT

CG0061 3.3 1 ALL ALL --STTPT

CG0062 3.2 1 ALL ALL --STTPT

CG0062 3.3 1 ALL ALL --STTPT

CG0063 3.2 1 EVT DS EPOCH
CG0065 3.2 1 EVT DS DSDECOD
CG0065 3.3 1 EVT DS DSDECOD

CG0066 3.2 1 EVT DS DSDECOD

CG0067 3.2 1 EVT DS DSDECOD

CG0067 3.3 1 EVT DS DSDECOD

CG0068 3.2 1 EVT DS DSSTDTC

CG0068 3.3 1 EVT DS DSSTDTC

CG0069 3.2 1 EVT DS DSSTDTC

CG0069 3.3 1 EVT DS DSSTDTC

CG0071 3.2 1 EVT DS DSTERM

CG0071 3.3 1 EVT DS DSTERM

CG0073 3.2 2 EVT DS EPOCH

CG0075 3.2 1 EVT DV DVSTDTC

CG0075 3.3 1 EVT DV DVSTDTC

CG0076 3.2 1 EVT DV GEN

CG0076 3.3 1 EVT DV GEN

CG0077 3.2 1 EVT MH MHCAT

CG0077 3.3 1 EVT MH MHCAT

CG0078 3.2 1 EVT MH MHENDTC

CG0078 3.3 1 EVT MH MHENDTC

CG0079 3.2 1 EVT MH MHSTDTC

CG0079 3.3 1 EVT MH MHSTDTC

CG0081 3.2 1 EVT, INT NOT(DS, DV, EX) --STAT

CG0081 3.3 1 EVT, INT NOT(DS, DV, EX) --STAT
CG0082 3.2 1 EVT, FND ALL --BDSYCD
CG0082 3.3 1 EVT, FND ALL --BDSYCD
CG0083 3.2 1 EVT, FND ALL --BDSYCD
CG0083 3.3 1 EVT, FND ALL --BDSYCD
CG0084 3.2 1 EVT, FND AE, LB --TOX
CG0084 3.3 1 EVT, FND AE, LB --TOX

CG0085 3.2 1 EVT, INT NOT(DS, DV, EX) --PRESP

CG0085 3.3 1 EVT, INT NOT(DS, DV, EX) --PRESP

NOT(AE, DS, DV,

CG0086 3.2 1 EVT, INT EX) --OCCUR

NOT(AE, DS, DV,

CG0086 3.3 1 EVT, INT EX) --OCCUR
NOT(AE, DS, DV,
CG0087 3.2 1 EVT, INT EX) --OCCUR

NOT(AE, DS, DV,

CG0087 3.3 1 EVT, INT EX) --OCCUR

NOT(AE, DS, DV,

CG0088 3.2 1 EVT, INT EX) --OCCUR

NOT(AE, DS, DV,

CG0088 3.3 1 EVT, INT EX) --OCCUR
NOT(AE, DS, DV,
CG0089 3.2 1 EVT, INT EX) --PRESP

NOT(AE, DS, DV,

CG0089 3.3 1 EVT, INT EX) --PRESP

CG0090 3.2 1 ALL ALL --TPTREF

CG0090 3.3 1 ALL ALL --TPTREF

CG0092 3.2 1 ALL ALL --TPTREF

CG0092 3.3 1 ALL ALL --TPTREF

CG0093 3.2 1 ALL ALL --TPTREF

CG0093 3.3 1 ALL ALL --TPTREF

NOT(EX, AE, DS,
CG0094 3.2 1 ALL DV, IE) --STAT
NOT(EX, AE, DS,
CG0094 3.3 1 ALL DV, IE) --STAT
CG0095 3.2 2 ALL ALL --LAT
CG0095 3.3 1 ALL ALL --LAT
CG0096 3.2 1 INT CM CMDECOD

CG0096 3.3 1 INT CM CMDECOD

CG0097 3.2 1 INT CM CMTRT
CG0097 3.3 1 INT CM CMTRT

CG0098 3.2 1 INT CM CMTRT

CG0098 3.3 1 INT CM CMTRT

CG0099 3.2 1 INT CM, SU --MODIFY

CG0099 3.3 1 INT CM, SU --MODIFY

CG0100 3.2 1 INT EC ECDOSE

CG0100 3.3 1 INT EC ECDOSE

CG0101 3.2 2 INT EC ECDOSE

CG0101 3.3 2 INT EC ECDOSE

CG0102 3.2 1 INT EX EXDOSE

CG0102 3.3 1 INT EX EXDOSE

CG0103 3.2 1 INT EX EXDOSU
CG0103 3.3 1 INT EX EXDOSU

CG0104 3.2 1 INT EX EXTRT

CG0104 3.3 1 INT EX EXTRT

CG0105 3.2 1 INT EX EXVAMT

CG0105 3.3 1 INT EX EXVAMT

CG0106 3.2 1 INT ALL --VAMT

CG0106 3.3 1 INT ALL --VAMT

CG0107 3.2 1 INT EX EXVAMTU

CG0107 3.3 1 INT EX EXVAMTU

CG0108 3.2 2 INT ALL --VAMTU

CG0108 3.3 2 INT ALL --VAMTU

CG0109 3.2 1 SPC DM ACTARMCD

CG0110 3.2 1 INT ALL --DOSE
CG0110 3.3 1 INT ALL --DOSE

CG0111 3.2 1 INT ALL --DOSTXT

CG0111 3.3 1 INT ALL --DOSTXT

CG0112 3.2 1 INT ALL --DOSTXT

CG0112 3.3 1 INT ALL --DOSTXT

CG0114 3.2 1 INT ALL --DOSU
CG0114 3.3 1 INT ALL --DOSU

CG0115 3.2 2 INT, FND, EVT ALL --PORTOT

CG0115 3.3 2 INT, FND, EVT ALL --PORTOT

CG0116 3.2 2 INT, FND, EVT ALL --DIR

CG0116 3.3 2 INT, FND, EVT ALL --DIR

CG0117 3.2 1 SPC DM ACTARM

CG0118 3.2 1 SPC DM ACTARM

CG0119 3.2 1 SPC DM ACTARM

CG0120 3.2 1 SPC DM ARM
CG0121 3.2 1 SPC DM ARM

CG0122 3.2 1 SPC DM ARM

CG0123 3.2 1 SPC DM ACTARMCD

CG0123 3.3 1 SPC DM ACTARMCD

CG0124 3.2 1 SPC DM ACTARMCD

CG0125 3.2 1 SPC DM ACTARMCD

CG0126 3.2 1 SPC DM ARMCD

CG0127 3.2 1 SPC DM ACTARMCD

CG0128 3.2 1 SPC DM ARMCD

CG0129 3.2 1 SPC DM ARMCD

CG0131 3.2 1 SPC DM DTHFL
CG0131 3.3 1 SPC DM DTHFL

CG0132 3.2 1 SPC DM DTHFL

CG0132 3.3 1 SPC DM DTHFL

CG0133 3.2 1 SPC DM DTHFL

CG0133 3.3 1 SPC DM DTHFL

CG0134 3.2 1 SPC DM DTHFL

CG0134 3.3 1 SPC DM DTHFL

CG0135 3.2 1 SPC DM DTHFL

CG0135 3.3 1 SPC DM DTHFL

CG0136 3.2 1 SPC DM DTHFL

CG0136 3.3 1 SPC DM DTHFL

CG0138 3.2 1 SPC DM QNAM

CG0140 3.2 1 SPC DM RACE

CG0141 3.2 1 SPC DM RFENDTC

CG0142 3.2 2 SPC DM RFENDTC

CG0143 3.2 1 SPC DM RFICDTC

CG0143 3.3 1 SPC DM RFICDTC

CG0145 3.2 1 SPC DM RFSTDTC

CG0146 3.2 1 SPC DM RFSTDTC

CG0147 3.2 1 SPC DM RFXENDTC

CG0147 3.3 1 SPC DM RFXENDTC

CG0148 3.2 1 SPC DM RFXSTDTC

CG0148 3.3 1 SPC DM RFXSTDTC

CG0149 3.2 1 SPC DM SETCD
CG0149 3.3 1 SPC DM SETCD
CG0150 3.2 1 SPC DM SUBJID
CG0150 3.3 1 SPC DM SUBJID
CG0151 3.2 1 SPC DM USUBJID
CG0151 3.3 1 SPC DM USUBJID

CG0152 3.2 1 SPC SE ELEMENT

CG0152 3.3 1 SPC SE ELEMENT

CG0153 3.2 1 SPC, TDM DM, TA ARMCD

CG0153 3.3 1 SPC, TDM DM, TA ARMCD

CG0154 3.2 1 SPC, TDM SE, TA, TE ETCD

CG0154 3.3 1 SPC, TDM SE, TA, TE ETCD

NOT(APRELSUB,
CG0155 3.2 1 AP POOLDEF, FA) DOMAIN

NOT(APRELSUB,
CG0155 3.3 1 AP POOLDEF, FA) DOMAIN

CG0156 3.2 1 AP ALL APID

CG0156 3.3 1 AP ALL APID

CG0157 3.2 1 AP ALL RSUBJID

CG0157 3.3 1 AP ALL RSUBJID

CG0158 3.2 1 AP ALL RSUBJID

CG0158 3.3 1 AP ALL RSUBJID

CG0159 3.2 1 AP ALL RSUBJID

CG0159 3.3 1 AP ALL RSUBJID

CG0160 3.2 1 AP ALL SREL

CG0160 3.3 1 AP ALL SREL

CG0161 3.2 1 AP ALL SREL

CG0161 3.3 1 AP ALL SREL

CG0162 3.2 1 AP ALL SREL

CG0162 3.3 1 AP ALL SREL

CG0163 3.2 1 SPC CO IDVAR

CG0163 3.3 1 SPC CO IDVAR

CG0164 3.2 1 SPC CO IDVAR

CG0164 3.3 1 SPC CO IDVAR

CG0166 3.2 1 SPC CO RDOMAIN

CG0166 3.3 1 SPC CO RDOMAIN

CG0167 3.2 1 SPC CO GEN

CG0167 3.3 1 SPC CO GEN

CG0168 3.2 1 SPC CO CODTC

CG0168 3.3 1 SPC CO CODTC

CG0169 3.2 1 SPC CO COVAL

CG0169 3.3 1 SPC CO COVAL

CG0171 3.2 1 FND SS SSDTC

CG0171 3.3 1 FND SS SSDTC

CG0172 3.2 2 FND SS SSDTC

CG0172 3.3 2 FND SS SSDTC

CG0173 3.2 1 FND FA FATESTCD

CG0173 3.3 1 FND FA FATESTCD

CG0174 3.2 1 FND FA FAOBJ

CG0174 3.3 1 FND FA FAOBJ

CG0175 3.2 1 FND IE IEORRES

CG0175 3.3 1 FND IE IEORRES

CG0176 3.2 1 FND IE IEORRES

CG0176 3.3 1 FND IE IEORRES

CG0177 3.2 1 FND IE IESTRESC
CG0177 3.3 1 FND IE IESTRESC

CG0178 3.2 1 FND IE IETEST

CG0178 3.3 1 FND IE IETEST

CG0179 3.2 1 FND IE IETESTCD

CG0179 3.3 1 FND IE IETESTCD

CG0180 3.2 1 FND LB LBORNRLO

CG0180 3.3 1 FND LB LBORNRLO

CG0181 3.2 1 FND LB LBORNRHI

CG0181 3.3 1 FND LB LBORNRHI

CG0182 3.2 1 FND LB LBSTNRLO

CG0182 3.3 1 FND LB LBSTNRLO

CG0183 3.2 1 FND LB LBSTNRHI

CG0183 3.3 1 FND LB LBSTNRHI

CG0184 3.2 1 FND LB LBSTNRC

CG0184 3.3 1 FND LB LBSTNRC

CG0185 3.2 1 FND LB LBTOXGR

CG0185 3.3 1 FND LB LBTOXGR

CG0186 3.2 1 FND LB LBORNRLO
CG0186 3.3 1 FND LB LBORNRLO
CG0187 3.2 1 FND LB LBORNRHI
CG0187 3.3 1 FND LB LBORNRHI

CG0188 3.2 1 FND LB LBSTNRLO

CG0188 3.3 1 FND LB LBSTNRLO

CG0189 3.2 1 FND LB LBSTNRHI

CG0189 3.3 1 FND LB LBSTNRHI

CG0190 3.2 1 FND LB LBSTNRC
CG0190 3.3 1 FND LB LBSTNRC

CG0191 3.2 1 FND MS GEN

CG0191 3.3 1 FND MS GEN

CG0192 3.2 1 FND MB MBTESTCD

CG0193 3.2 2 FND MB MBRESCAT

CG0196 3.2 1 FND PE PEORRES

CG0196 3.3 1 FND PE PEORRES

CG0197 3.2 1 FND PE PESTRESC

CG0197 3.3 1 FND PE PESTRESC

CG0198 3.2 1 SPC RELREC GEN

CG0198 3.3 1 SPC RELREC GEN

CG0200 3.2 1 SPC RELREC RELID

CG0200 3.3 1 SPC RELREC RELID

CG0201 3.2 1 SPC RELREC IDVAR

CG0201 3.3 1 SPC RELREC IDVAR

CG0202 3.2 2 SPC SUPP-- QEVAL

CG0202 3.3 2 SPC SUPP-- QEVAL

CG0203 3.2 1 SPC SUPP-- IDVAR

CG0203 3.3 1 SPC SUPP-- IDVAR

CG0204 3.2 1 SPC SUPP-- IDVARVAL

CG0204 3.3 1 SPC SUPP-- IDVARVAL

CG0205 3.2 1 SPC SUPP-- GEN

CG0205 3.3 1 SPC SUPP-- GEN

CG0206 3.2 1 SPC SE TAETORD

CG0206 3.3 1 SPC SE TAETORD

CG0207 3.2 1 SPC SE SEENDTC

CG0207 3.3 1 SPC SE SEENDTC

CG0208 3.2 2 SPC SE SESTDTC

CG0208 3.3 2 SPC SE SESTDTC

CG0209 3.2 2 SPC SE SEENDTC

CG0209 3.3 2 SPC SE SEENDTC

CG0210 3.2 1 SPC SE ETCD

CG0210 3.3 1 SPC SE ETCD

CG0211 3.2 1 SPC SE ETCD

CG0211 3.3 1 SPC SE ETCD

CG0213 3.2 1 SPC SV VISITNUM

CG0213 3.3 1 SPC SV VISITNUM

CG0214 3.2 1 SPC SV VISITNUM

CG0214 3.3 1 SPC SV VISITNUM
CG0215 3.2 1 SPC SV VISIT
CG0215 3.3 1 SPC SV VISIT

CG0216 3.2 1 SPC SV VISITDY

CG0216 3.3 1 SPC SV VISITDY

CG0217 3.2 1 SPC SV TAETORD

CG0217 3.3 1 SPC SV TAETORD

CG0218 3.2 1 SPC SV EPOCH

CG0218 3.3 1 SPC SV EPOCH

CG0219 3.2 1 INT, FND, EVT NOT(IE, SC) GEN

CG0219 3.3 1 INT, FND, EVT NOT(IE, SC) GEN

CG0220 3.2 1 ALL ALL --STDY

CG0220 3.3 1 ALL ALL --STDY

CG0221 3.2 1 ALL ALL --STDY

CG0221 3.3 1 ALL ALL --STDY

CG0222 3.2 1 ALL ALL --ENDY

CG0222 3.3 1 ALL ALL --ENDY

CG0223 3.2 1 ALL ALL --ENDY

CG0223 3.3 1 ALL ALL --ENDY

CG0225 3.2 1 ALL ALL VISITDY

CG0225 3.3 1 ALL ALL VISITDY

CG0226 3.2 1 ALL ALL --STRF

CG0226 3.3 1 ALL ALL --STRF

CG0227 3.2 1 ALL ALL --ENRF

CG0227 3.3 1 ALL ALL --ENRF

CG0232 3.2 1 ALL ALL --STRTPT

CG0232 3.3 1 ALL ALL --STRTPT

CG0233 3.2 1 ALL ALL --STRTPT

CG0233 3.3 1 ALL ALL --STRTPT

CG0234 3.2 1 ALL ALL --ENRTPT

CG0234 3.3 1 ALL ALL --ENRTPT

CG0235 3.2 1 ALL ALL --ENRTPT

CG0235 3.3 1 ALL ALL --ENRTPT

CG0236 3.2 1 FND ALL --DTC

CG0236 3.3 1 FND ALL --DTC

CG0237 3.2 1 EVT, INT ALL --DTC

CG0237 3.3 1 EVT, INT ALL --DTC

CG0238 3.2 1 FND ALL --ORRES

CG0238 3.3 1 FND ALL --ORRES

CG0240 3.2 2 ALL ALL --TPT

CG0240 3.3 2 ALL ALL --TPT

CG0241 3.2 1 ALL ALL --ELTM

CG0241 3.3 1 ALL ALL --ELTM

CG0244 3.2 2 TDM TA, TV ARM

CG0246 3.2 1 TDM, SPC TA, TE, SE ETCD
CG0246 3.3 1 TDM, SPC TA, TE, SE ETCD
CG0247 3.2 1 TDM TA TAETORD
CG0247 3.3 1 TDM TA TAETORD
CG0248 3.2 1 TDM TA TAETORD
CG0248 3.3 1 TDM TA TAETORD

CG0249 3.2 1 TDM TA TATRANS

CG0249 3.3 1 TDM TA TATRANS

CG0250 3.2 1 TDM TA EPOCH
CG0250 3.3 1 TDM TA EPOCH

CG0251 3.2 1 TDM TA TABRANCH

CG0251 3.3 1 TDM TA TABRANCH

CG0252 3.2 1 TDM TA TATRANS

CG0252 3.3 1 TDM TA TATRANS

CG0253 3.2 1 TDM TI TIVERS

CG0253 3.3 1 TDM TI TIVERS

CG0254 3.2 1 TDM TI TIVERS

CG0254 3.3 1 TDM TI TIVERS

CG0255 3.2 1 TDM TI IETESTCD

CG0255 3.3 1 TDM TI IETESTCD

CG0256 3.2 1 TDM TI IETESTCD

CG0256 3.3 1 TDM TI IETESTCD

CG0257 3.2 1 TDM TS TSPARMCD

CG0257 3.3 1 TDM TS TSPARMCD

CG0258 3.2 1 TDM TS TSPARM
CG0258 3.3 1 TDM TS TSPARM
CG0259 3.2 1 TDM TS TSVALNF
CG0259 3.3 1 TDM TS TSVALNF

CG0260 3.2 1 TDM TS TSVALNF

CG0260 3.3 1 TDM TS TSVALNF

CG0261 3.2 1 TDM TS TSVAL

CG0261 3.3 1 TDM TS TSVAL

CG0262 3.2 1 TDM TS TSVALn

CG0262 3.3 1 TDM TS TSVALn

CG0265 3.2 1 TDM TS TSVALCD
CG0265 3.3 1 TDM TS TSVALCD
CG0266 3.2 1 TDM TS TSVCDREF
CG0266 3.3 1 TDM TS TSVCDREF
CG0267 3.2 1 TDM TS TSVCDVER
CG0267 3.3 1 TDM TS TSVCDVER
CG0268 3.2 1 TDM TS TSSEQ
CG0268 3.3 1 TDM TS TSSEQ

CG0269 3.2 1 TDM TS TSVAL

CG0269 3.3 1 TDM TS TSVAL

CG0270 3.2 1 TDM TS TSVAL

CG0270 3.3 1 TDM TS TSVAL

CG0271 3.2 1 TDM TS TSVAL

CG0271 3.3 1 TDM TS TSVAL

CG0272 3.2 2 TDM TS TSVAL

CG0272 3.3 2 TDM TS TSVAL

CG0273 3.2 1 TDM TS TSVAL

CG0273 3.3 1 TDM TS TSVAL

CG0275 3.2 1 TDM TS TSVAL

CG0275 3.3 1 TDM TS TSVAL

CG0276 3.2 1 TDM TS TSVAL

CG0276 3.3 1 TDM TS TSVAL

CG0277 3.2 1 TDM TS TSVAL

CG0277 3.3 1 TDM TS TSVAL

CG0278 3.2 1 TDM TS TSVAL

CG0278 3.3 1 TDM TS TSVAL

CG0279 3.2 1 TDM TS TSVAL

CG0279 3.3 1 TDM TS TSVAL

CG0280 3.2 1 TDM TS TSVAL

CG0280 3.3 1 TDM TS TSVAL

CG0281 3.2 1 TDM TS TSPARMCD

CG0281 3.3 1 TDM TS TSPARMCD

CG0282 3.2 1 TDM TS TSVAL

CG0282 3.3 1 TDM TS TSVAL

CG0283 3.2 1 TDM TS TSVAL

CG0283 3.3 1 TDM TS TSVAL

CG0284 3.2 1 TDM TS TSVAL

CG0284 3.3 1 TDM TS TSVAL

CG0285 3.2 1 TDM TS TSVAL

CG0285 3.3 1 TDM TS TSVAL

CG0286 3.2 1 TDM TS TSVAL

CG0286 3.3 1 TDM TS TSVAL

CG0287 3.2 1 TDM TS GEN

CG0287 3.3 1 TDM TS GEN

CG0288 3.2 1 TDM TS TSVALCD
CG0288 3.3 1 TDM TS TSVALCD
CG0289 3.2 1 TDM TS TSVCDVER
CG0289 3.3 1 TDM TS TSVCDVER

CG0291 3.2 1 TDM TS TSVAL

CG0291 3.3 1 TDM TS TSVAL

CG0292 3.2 1 TDM TS GEN

CG0292 3.3 1 TDM TS GEN

CG0293 3.2 1 TDM TV ARMCD

CG0293 3.3 1 TDM TV ARMCD

CG0294 3.2 1 TDM TV ARM

CG0294 3.3 1 TDM TV ARM

CG0295 3.2 1 TDM TV ARMCD

CG0295 3.3 1 TDM TV ARMCD

CG0296 3.2 1 TDM TV ARM

CG0296 3.3 1 TDM TV ARM

CG0297 3.2 1 TDM TV ARMCD

CG0297 3.3 1 TDM TV ARMCD

CG0298 3.2 1 TDM TV VISIT
CG0298 3.3 1 TDM TV VISIT

CG0299 3.2 1 FND TR TRLOC

CG0299 3.3 1 FND TR TRLOC

CG0300 3.2 1 FND TR TRLAT

CG0300 3.3 1 FND TR TRLAT

CG0301 3.2 1 FND TR TRDIR

CG0301 3.3 1 FND TR TRDIR

CG0302 3.2 1 FND TR TRPORTOT

CG0302 3.3 1 FND TR TRPORTOT

CG0303 3.2 1 ALL ALL GEN

CG0304 3.2 1 EVT AE AEREASND

CG0304 3.3 1 EVT AE AEREASND

CG0307 3.2 1 TDM TS TSPARMCD
CG0307 3.3 1 TDM TS TSPARMCD
NOT(AP--,
CG0308 3.2 1 ALL RELREC) DOMAIN
NOT(AP--,
CG0308 3.3 1 ALL RELREC) DOMAIN
CG0309 3.2 1 ALL AP-- DOMAIN
CG0309 3.3 1 ALL AP-- DOMAIN

CG0310 3.2 1 ALL ALL GEN

CG0310 3.3 1 ALL ALL GEN

CG0311 3.2 1 ALL ALL GEN

CG0311 3.3 1 ALL ALL GEN

CG0312 3.2 1 ALL ALL DOMAIN

CG0312 3.3 1 ALL ALL DOMAIN

CG0313 3.2 1 ALL ALL GEN

CG0314 3.2 1 ALL SUPP-- QNAM

CG0314 3.3 1 ALL SUPP-- QNAM

CG0318 3.2 1 FND PC GEN

CG0318 3.3 1 FND PC GEN

CG0320 3.2 1 FND ALL --TESTCD

CG0320 3.3 1 FND ALL --TESTCD

CG0321 3.2 1 ALL ALL GEN

CG0321 3.3 1 ALL ALL GEN

CG0322 3.2 1 TDM TE, TA ELEMENT

CG0322 3.3 1 TDM TE, TA ELEMENT

CG0323 3.2 1 TDM TE, TA ELEMENT

CG0323 3.3 1 TDM TE, TA ELEMENT

CG0324 3.2 1 TDM TE TEENRL

CG0324 3.3 1 TDM TE TEENRL

CG0325 3.2 2 TDM TE ETCD

CG0325 3.3 2 TDM TE ETCD

CG0328 3.2 1 TDM TE TEENRL

CG0328 3.3 1 TDM TE TEENRL

CG0329 3.2 1 TDM TE TEDUR

CG0329 3.3 1 TDM TE TEDUR

CG0330 3.2 1 ALL ALL GEN

CG0330 3.3 1 ALL ALL GEN

NOT(RELREC,
CG0332 3.2 1 ALL RELSUB, SUPP'--) GEN

NOT(RELREC,
CG0332 3.3 1 ALL RELSUB, SUPP'--) GEN

CG0333 3.2 1 ALL ALL GEN

CG0333 3.3 1 ALL ALL GEN

CG0334 3.2 1 ALL SUPP'--'-- RDOMAIN

CG0334 3.3 1 ALL SUPP'--'-- RDOMAIN

CG0336 3.2 1 ALL ALL --CAT

CG0336 3.3 1 ALL ALL --CAT

CG0337 3.2 1 EVT ALL --CAT

CG0337 3.3 1 EVT ALL --CAT

CG0338 3.2 1 EVT ALL --SCAT

CG0338 3.3 1 EVT ALL --SCAT

CG0339 3.2 1 EVT ALL --CAT

CG0339 3.3 1 EVT ALL --CAT

CG0340 3.2 1 EVT ALL --SCAT

CG0340 3.3 1 EVT ALL --SCAT

CG0341 3.2 1 FND ALL --TESTCD

CG0341 3.3 1 FND ALL --TESTCD

CG0342 3.2 1 INT ALL --TRT

CG0342 3.3 1 INT ALL --TRT

CG0343 3.2 1 EVT ALL --TERM

CG0343 3.3 1 EVT ALL --TERM

CG0344 3.2 1 FND ALL --TESTCD

CG0344 3.3 1 FND ALL --TESTCD

CG0345 3.2 1 INT ALL --TRT

CG0345 3.3 1 INT ALL --TRT

CG0346 3.2 1 EVT ALL --TERM

CG0346 3.3 1 EVT ALL --TERM

CG0347 3.2 1 FND ALL --ORRES

CG0347 3.3 1 FND ALL --ORRES

CG0348 3.2 1 FND ALL --ORRES

CG0348 3.3 1 FND ALL --ORRES

CG0349 3.2 1 FND, INT, EVT ALL GEN

CG0349 3.3 1 FND, INT, EVT ALL GEN

CG0350 3.2 1 ALL ALL --SCAT

CG0350 3.3 1 ALL ALL --SCAT

CG0351 3.2 1 ALL ALL GEN
CG0351 3.3 1 ALL ALL GEN

CG0352 3.2 1 ALL ALL --DTHREL

CG0352 3.3 1 ALL ALL --DTHREL

CG0353 3.2 1 ALL ALL --EXCLFL

CG0353 3.3 1 ALL ALL --EXCLFL

CG0354 3.2 1 ALL ALL --REASEX

CG0354 3.3 1 ALL ALL --REASEX

CG0355 3.2 1 ALL ALL --DETECT

CG0355 3.3 1 ALL ALL --DETECT

CG0356 3.2 1 SPC DM SPECIES

CG0356 3.3 1 SPC DM SPECIES

CG0357 3.2 1 SPC DM STRAIN

CG0357 3.3 1 SPC DM STRAIN

CG0358 3.2 1 SPC DM SBSTRAIN

CG0358 3.3 1 SPC DM SBSTRAIN

CG0359 3.2 1 ALL ALL GEN

CG0359 3.3 1 ALL ALL GEN

CG0361 3.2 1 SPC RELSUB POOLID
CG0361 3.3 1 SPC RELSUB POOLID
CG0362 3.2 1 SPC RELSUB USUBJID
CG0362 3.3 1 SPC RELSUB USUBJID
CG0363 3.2 1 SPC RELSUB RSUBJID

CG0363 3.3 1 SPC RELSUB RSUBJID

CG0364 3.2 1 SPC RELSUB RSUBJID

CG0364 3.3 1 SPC RELSUB RSUBJID

CG0365 3.2 1 AP ALL RDEVID

CG0365 3.3 1 AP ALL RDEVID

CG0366 3.2 1 AP ALL RSUBJID

CG0366 3.3 1 AP ALL RSUBJID

CG0367 3.2 1 AP ALL RSUBJID

CG0367 3.3 1 AP ALL RSUBJID

CG0368 3.2 1 SPC DM GEN

CG0368 3.3 1 SPC DM GEN

CO, SUPP--,
CG0369 3.2 1 SPC RELREC RDOMAIN
CO, SUPP--,
CG0369 3.3 1 SPC RELREC RDOMAIN
CO, SUPP--,
CG0370 3.2 1 SPC RELREC IDVAR
CO, SUPP--,
CG0370 3.3 1 SPC RELREC IDVAR
CO, SUPP--,
CG0371 3.2 1 SPC RELREC IDVARVAL
CO, SUPP--,
CG0371 3.3 1 SPC RELREC IDVARVAL

CG0372 3.2 1 FND, TDM ALL --TESTCD

CG0372 3.3 1 FND, TDM ALL --TESTCD

CG0373 3.2 1 ALL ALL GEN

CG0373 3.3 1 ALL ALL GEN

CG0374 3.2 1 ALL ALL GEN
CG0374 3.3 1 ALL ALL GEN

CG0375 3.2 1 TDM TD TDANCVAR

CG0375 3.3 1 TDM TD TDANCVAR

CG0376 3.2 1 TDM TD TDSTOFF

CG0376 3.3 1 TDM TD TDSTOFF
CG0377 3.2 1 EVT AE, MH, CE --LLT
CG0377 3.3 1 EVT AE, MH, CE --LLT
CG0378 3.2 1 EVT AE, MH, CE --LLTCD
CG0378 3.3 1 EVT AE, MH, CE --LLTCD

CG0379 3.2 1 EVT AE --DECOD

CG0379 3.3 1 EVT AE --DECOD

CG0380 3.2 1 EVT AE, MH, CE --PTCD
CG0380 3.3 1 EVT AE, MH, CE --PTCD
CG0381 3.2 1 EVT AE, MH, CE --HLT
CG0381 3.3 1 EVT AE, MH, CE --HLT
CG0382 3.2 1 EVT AE, MH, CE --HLTCD
CG0382 3.3 1 EVT AE, MH, CE --HLTCD
CG0383 3.2 1 EVT AE, MH, CE --HLGT
CG0383 3.3 1 EVT AE, MH, CE --HLGT
CG0384 3.2 1 EVT AE, MH, CE --HLGTCD
CG0384 3.3 1 EVT AE, MH, CE --HLGTCD

CG0385 3.2 1 EVT AE, MH, CE --BODSYS

CG0385 3.3 1 EVT AE, MH, CE --BODSYS

CG0386 3.2 1 EVT AE, MH, CE --BDSYCD

CG0386 3.3 1 EVT AE, MH, CE --BDSYCD

CG0387 3.2 1 EVT AE --SER
CG0387 3.3 1 EVT AE --SER

CG0388 3.2 1 EVT AE --SCAN

CG0389 3.2 1 EVT AE --SCONG

CG0390 3.2 1 EVT AE --SDISAB

CG0391 3.2 1 EVT AE --SDTH
CG0392 3.2 1 EVT AE --SHOSP
CG0393 3.2 1 EVT AE --SLIFE
CG0394 3.2 1 EVT AE --SOD
CG0395 3.2 1 EVT AE --SMIE

CG0396 3.2 1 EVT AE --CONTRT

CG0396 3.3 1 EVT AE --CONTRT

CG0397 3.2 1 FND ALL --STRESC

CG0397 3.3 1 FND ALL --STRESC

CG0398 3.2 2 EVT DS GEN

CG0399 3.2 1 FND ALL --ULOQ

CG0399 3.3 1 FND ALL --ULOQ

CG0400 3.2 1 FND ALL --LOINC

CG0400 3.3 1 FND ALL --LOINC

CG0404 3.2 2 EVT, INT NOT(DS, DV, EX) --STAT

CG0404 3.3 2 EVT, INT NOT(DS, DV, EX) --STAT

CG0406 3.2 1 FND NOT(IE) --TEST

CG0406 3.3 1 FND NOT(IE) --TEST

CG0407 3.2 1 INT EX GEN

CG0407 3.3 1 INT EX GEN

CG0408 3.2 1 ALL ALL GEN

CG0408 3.3 1 ALL ALL GEN

CG0409 3.2 1 ALL ALL STUDYID

CG0409 3.3 1 ALL ALL STUDYID
CG0410 3.2 2 SPC SV VISITNUM

CG0410 3.3 2 SPC SV VISITNUM

CG0411 3.2 1 ALL SUPP-- GEN

CG0411 3.3 1 ALL SUPP-- GEN

CG0412 3.2 1 EVT DS GEN

CG0413 3.2 1 ALL ALL DOMAIN

CG0413 3.3 1 ALL ALL DOMAIN

CG0414 3.2 1 SPC, TDM SE, TA ETCD

CG0414 3.3 1 SPC, TDM SE, TA ETCD

CG0415 3.2 1 TDM TA ARMCD
CG0415 3.3 1 TDM TA ARMCD

CG0416 3.2 1 SPC SUPP-- QLABEL

CG0416 3.3 1 SPC SUPP-- QLABEL

CG0417 3.2 1 SPC SUPP-- QNAM

CG0417 3.3 1 SPC SUPP-- QNAM

CG0418 3.2 1 ALL ALL TAETORD

CG0418 3.3 1 ALL ALL TAETORD

CG0419 3.2 1 SPC RELREC RELTYPE

CG0419 3.3 1 SPC RELREC RELTYPE

CG0420 3.2 1 INT, EVT ALL --STRF

CG0420 3.3 1 INT, EVT ALL --STRF

CG0421 3.2 1 INT, EVT ALL --ENRF

CG0421 3.3 1 INT, EVT ALL --ENRF

CG0422 3.2 1 FND ALL --STAT
CG0422 3.3 1 FND ALL --STAT

CG0423 3.2 1 INT ALL --TRTV

CG0423 3.3 1 INT ALL --TRTV
CG0425 3.2 1 FND ALL --STRESU

CG0425 3.3 1 FND ALL --STRESU

CG0426 3.2 1 FND ALL --STRESC

CG0426 3.3 1 FND ALL --STRESC

CG0427 3.2 1 FND ALL --STRESC

CG0427 3.3 1 FND ALL --STRESC

AE, MH, CE, EG,

CG0428 3.2 1 EVT, FND LB, PC, PP --TOXGR

AE, MH, CE, EG,

CG0428 3.3 1 EVT, FND LB, PC, PP --TOXGR
CG0429 3.2 1 ALL ALL --CAT

CG0429 3.3 1 ALL ALL --CAT

CG0430 3.2 1 ALL ALL --CAT

CG0430 3.3 1 ALL ALL --CAT

CG0431 3.2 1 ALL ALL GEN

CG0431 3.3 1 ALL ALL GEN

CG0432 3.2 1 SPC DM AGEU
CG0432 3.3 1 SPC DM AGEU
CG0433 3.2 1 SPC DM AGE
CG0433 3.3 1 SPC DM AGE
CG0434 3.2 1 SPC DM AGETXT
CG0434 3.3 1 SPC DM AGETXT
CG0435 3.2 1 SPC DM DTHFL

CG0435 3.3 1 SPC DM DTHFL

CG0436 3.2 1 EVT AE, MH, CE --SOC
CG0436 3.3 1 EVT AE, MH, CE --SOC
CG0437 3.2 1 EVT AE, MH, CE --SOCCD
CG0437 3.3 1 EVT AE, MH, CE --SOCCD

CG0438 3.2 1 TDM TS TSVAL

CG0438 3.3 1 TDM TS TSVAL

CG0439 3.2 1 TDM TS TSVAL

CG0439 3.3 1 TDM TS TSVAL

CG0440 3.2 1 TDM TS TSVAL

CG0440 3.3 1 TDM TS TSVAL

CG0441 3.2 1 TDM TS TSVAL

CG0441 3.3 1 TDM TS TSVAL

CG0442 3.2 1 TDM TS TSVAL

CG0442 3.3 1 TDM TS TSVAL

CG0443 3.2 1 TDM TS TSVALCD

CG0443 3.3 1 TDM TS TSVALCD

CG0444 3.2 1 TDM TS TSVCDREF

CG0444 3.3 1 TDM TS TSVCDREF

CG0445 3.2 1 TDM TS TSVAL

CG0445 3.3 1 TDM TS TSVAL

CG0446 3.2 1 TDM TS TSVALCD

CG0446 3.3 1 TDM TS TSVALCD

CG0448 3.2 1 TDM TS TSVAL

CG0448 3.3 1 TDM TS TSVAL

CG0449 3.2 1 TDM TS TSVALCD

CG0449 3.3 1 TDM TS TSVALCD

CG0450 3.2 1 TDM TS TSVAL

CG0450 3.3 1 TDM TS TSVAL

CG0451 3.2 1 TDM TS TSVALCD

CG0451 3.3 1 TDM TS TSVALCD

CG0453 3.2 1 TDM TS TSVAL

CG0453 3.3 1 TDM TS TSVAL

CG0454 3.2 1 TDM TS TSVALCD

CG0454 3.3 1 TDM TS TSVALCD

CG0455 3.2 1 TDM TS TSVCDREF

CG0455 3.3 1 TDM TS TSVCDREF

CG0456 3.2 1 TDM TS TSVCDREF

CG0456 3.3 1 TDM TS TSVCDREF

CG0457 3.2 1 TDM TS TSVAL

CG0457 3.3 1 TDM TS TSVAL

CG0458 3.2 1 TDM TS TSVCDREF

CG0458 3.3 1 TDM TS TSVCDREF

CG0459 3.2 1 TDM TS TSVALNF

CG0459 3.3 1 TDM TS TSVALNF

CG0460 3.2 1 EVT AE, MH, CE --HLT
CG0460 3.3 1 EVT AE, MH, CE --HLT
CG0461 3.2 1 EVT AE, MH, CE --HLGT
CG0461 3.3 1 EVT AE, MH, CE --HLGT

CG0462 3.2 2 INT EC ECDOSTXT

CG0462 3.3 2 INT EC ECDOSTXT

CG0463 3.2 1 INT ALL --TRT

CG0463 3.3 1 INT ALL --TRT

CG0464 3.2 1 EVT ALL --TERM

CG0464 3.3 1 EVT ALL --TERM

CG0465 3.2 1 SPC CO, SUPP-- IDVARVAL

CG0465 3.3 1 SPC CO, SUPP-- IDVARVAL

CG0466 3.2 1 FND ALL --LLOQ

CG0466 3.3 1 FND ALL --LLOQ

CG0467 3.2 1 FND ALL --STDTC

CG0467 3.3 1 FND ALL --STDTC

CG0468 3.2 1 ALL ALL --TPTNUM

CG0468 3.3 1 ALL ALL --TPTNUM

CG0501 3.3 1 ALL ALL MIDS

CG0502 3.3 1 ALL ALL RELMIDS

CG0503 3.3 1 ALL ALL MIDSDTC

CG0507 3.3 1 ALL ALL --USCHFL

CG0508 3.3 1 ALL ALL --IMPLBL

CG0509 3.3 1 ALL ALL FETUSID

CG0510 3.3 1 ALL ALL --NOMDY

CG0511 3.3 1 ALL ALL --NOMLBL

CG0512 3.3 1 SPC DM ACTARMCD

CG0513 3.3 1 SPC DM ARMNRS

CG0514 3.3 1 SPC DM ACTARM

CG0515 3.3 1 SPC DM ARMNRS

CG0516 3.3 1 SPC DM ARMCD

CG0517 3.3 1 SPC DM ARMNRS

CG0518 3.3 1 SPC DM ARM

CG0519 3.3 1 SPC DM ARMNRS

CG0520 3.3 1 SPC DM ARMNRS

CG0521 3.3 1 SPC DM ARM

CG0522 3.3 1 SPC DM ACTARM

CG0523 3.3 1 SPC DM ARMCD

CG0524 3.3 1 SPC DM ACTARMCD

CG0525 3.3 1 SPC DM RACE

CG0526 3.3 1 SPC DM RACE

CG0527 3.3 1 SPC DM RACE

CG0528 3.3 1 SPC DM QNAM

CG0529 3.3 1 SPC DM RFENDTC

CG0530 3.3 1 SPC DM RFENDTC

CG0531 3.3 1 SPC SUPPDM

CG0532 3.3 1 SPC DM RFSTDTC

CG0533 3.3 1 SPC DM RPATHCD
CG0534 3.3 1 SPC DM RFSTDTC

CG0535 3.3 1 EVT DS GEN

CG0536 3.3 1 EVT DS GEN

CG0537 3.3 1 EVT DS GEN

CG0538 3.3 1 EVT DS GEN

CG0539 3.3 1 EVT DS GEN

CG0540 3.3 1 EVT DS GEN

CG0541 3.3 1 FND ALL --LOBXFL

CG0542 3.3 1 FND NOT(EG) --BEATNO

CG0543 3.2 1 SPC, INT SE, PR --SEQ

CG0544 3.3 1 SPC, INT SM, SE, PR --SEQ

CG0545 3.3 1 SPC SM MIDSTYPE

CG0546 3.3 1 SPC SM MIDS

CG0547 3.3 1 SPC SM SMSTDTC

CG0548 3.3 1 FND ALL --ORREF

CG0549 3.3 1 FND ALL --STREFC

CG0550 3.3 1 FND ALL --STREFN

CG0551 3.3 1 FND ALL --STREFN

CG0552 3.3 1 FND ALL --RESLOC

CG0553 3.3 1 FND ALL --ORRES

CG0554 3.3 1 ALL ALL GEN

CG0555 3.3 1 FND PP PPORRESU

CG0556 3.3 1 FND PP PPORRESU

CG0557 3.3 1 FND PP PPORRESU

CG0558 3.3 1 FND PP PPSTRESU

CG0559 3.3 1 FND PP PPSTRESU

CG0560 3.3 1 FND PP PPSTRESU
CG0561 3.3 1 FND PE PESTRESC

CG0562 3.3 1 FND ALL --REPNUM

CG0563 3.3 1 RND RS RSDRFVL

CG0564 3.3 1 FND NOT(MS) --AGENT

CG0565 3.3 1 FND NOT(MS) --CONC

CG0566 3.3 1 FND NOT(MS) --CONCU

CG0567 3.3 1 EVT NOT(MH) --EVDTYP

CG0568 3.3 1 INT EX EXMETHOD

CG0569 3.3 1 FND ALL --STRESC

CG0570 3.3 1 TDM, SPC DM, TA, TV ARM

CG0571 3.2 1 ALL ALL --TPT

CG0571 3.3 1 ALL ALL --TPT

CG0572 3.2 1 ALL ALL --TPT

CG0572 3.3 1 ALL ALL --TPT

CG0573 3.2 1 ALL ALL --TPT

CG0573 3.3 1 ALL ALL --TPT

Rule

DOMAIN = valid Domain Code published by CDISC

--DUR collected and not derived

--DY calculated as per the study day algorithm as a non-zero interger value

--DY calculated as per the study day algorithm as a non-zero integer value

--DY = null

--ELTM = null

EPOCH in TA.EPOCH
EPOCH in TA.EPOCH

Variable Role = IG Role for domains in IG, Role = Model Role for custom domains

Variable Role = IG Role for domains in IG, Role = Model Role for custom domains
Variable Format = SDTM-specified controlled terminology and format guidelines for variables,
when provided
Variable Format = SDTM-specified controlled terminology and format guidelines for variables,
when provided

Variable Type = IG Type for domains in IG, Type = Model Type for custom domains

Variable = Model List of Allowed Variables for Observation Class

Variable present in dataset and ^= null

Variable present in dataset

Split dataset names length > 2 and <= 4

Split dataset names length <= 8

Each record is unique per sponsor defined key variables as documented in the define.xml

Value in associated codelist or 'MULTIPLE'

Value in associated codelist or 'OTHER'

--LNKGRP present in another domain

--LNKID present in another domain

--RFTDTC = null
--RFTDTC = null
--SCAT ^= --CAT
--SCAT ^= --CAT

--SEQ is a unique number per USUBJID per domain, or a unique number per POOLID per
domain, including when the domain is split into multiple files

USUBJID in DM.USUBJID

VISIT in TV.VISIT

VISITDY = TV.VISITDY

VISITNUM in TV.VISITNUM

VISITNUM in SV.VISITNUM

VISIT and VISITNUM have a one-to-one relationship

--SOCCD = --BDSYCD
--SOCCD = --BDSYCD

--BODSYS = --SOC

AEOCCUR not present in dataset

AESER = 'Y'

AESER = 'N'
AESER = 'N'

AESMIE = 'Y'

AESTAT not present in dataset

--ENRTPT ^= null

--ENTPT ^= null

--MODIFY ^= null

--DECOD and --PTCD have a one-to-one relationship

--DECOD ^= null
--DECOD ^= null

--REASND not present in dataset

--STAT not present in dataset

--ENRTPT present in dataset

--ENTPT present in dataset

--STRTPT ^= null

--STRTPT present in dataset

--STTPT ^= null

--STTPT present in dataset

EPOCH ^= null
DSDECOD = 'COMPLETED'
DSDECOD = 'COMPLETED'

DSTERM = DSDECOD

DSDECOD = 'DEATH'

For each subject, earliest DSSTDTC = DM.RFICDTC

DSSTDTC = DM.DTHDTC

DSTERM = 'COMPLETED' or the reason for discontinuation

EPOCH = null

DVSTDTC >= DM.RFICDTC

Event is not derived

MHCAT ^= the same value for all records

MHENDTC < DM.RFSTDTC

MHSTDTC < DM.RFSTDTC

--STAT = 'NOT DONE'

--STAT = 'NOT DONE'
--BODSYS ^= null
--BODSYS ^= null
--BDSYCD and '--BODSYS have a one-to-one relationship
--BDSYCD and '--BODSYS have a one-to-one relationship
--TOX not present in dataset
--TOX not present in dataset

--PRESP in ('Y', null)

--OCCUR ^= null

--OCCUR ^= null
--OCCUR = null

--OCCUR = null

--OCCUR not present in dataset

--PRESP = 'Y'

--TPTREF present in dataset

--TPTREF not present in dataset

--STAT = 'NOT DONE'

--LAT not present in dataset
--LAT not present in dataset
CMDECOD ^= null

CMDECOD ^= null
CMTRT = collected on CRF
CMTRT = collected on CRF

CMTRT = collected medication name only

--MODIFY ^= null

ECDOSE > 0

ECDOSE > 0
ECDOSE = null or > 0

ECDOSE = null or > 0

EXDOSE = 0

EXDOSE = 0
EXDOSU = protocol-specified unit
EXDOSU = protocol-specified unit

EXTRT = protocol-specified treatment

EXVAMT not present in dataset

--VAMT = null

EXVAMTU not present in dataset

--VAMTU = null

DM.ACTARMCD in ('SCRNFAIL', 'NOTASSGN', 'NOTTRT')

--DOSE = null
--DOSE = null

--DOSTXT = null

--DOSTXT value is non-numeric

--DOSU ^= null
--DOSU ^= null

--PORTOT not present in dataset

--DIR not present in dataset

ACTARM in ('Screen Failure', 'Not Assigned', 'Not Treated', 'Unplanned Treatment')

ACTARM in TA.ARM

ACTARM = ARM
ARM in ('Screen Failure', 'Not Assigned')
ARM in TA.ARM

ARM = ACTARM

ACTARMCD value length <= 20

ACTARMCD in ('SCRNFAIL', 'NOTASSGN', 'NOTTRT', 'UNPLAN')

ACTARMCD in TA.ARMCD

ARMCD in TA.ARMCD

ACTARMCD = ARMCD

ARMCD in ('SCRNFAIL', 'NOTASSGN')

ARMCD = ACTARMCD
DTHFL in ('Y',null)
DTHFL in ('Y',null)

DTHFL = 'Y'

DTHFL = 'Y'
DTHFL = 'Y'

DTHFL = 'Y'

Population flags in SUPPDM

RACE = 'MULTIPLE'

RFENDTC = null
RFENDTC ^= null

RFICDTC = earliest DS.DSSTDTC

RFSTDTC = null

RFSTDTC ^= null

RFXENDTC = latest value of EX.EXSTDTC or EX.EXENDTC

RFXSTDTC = earliest EX.EXSTDTC for that subject

SETCD value length <= 8
SETCD value length <= 8
SUBJID unique within a study
SUBJID unique within a study
USUBJID unique within a submission
USUBJID unique within a submission

ELEMENT = null

ARMCD value length <= 20

ELEMENT and ETCD have a one-to-one relationship

Value length = 4 characters beginning with 'AP' and ending with 2 character SDTM domain

APID in POOLDEF.POOLID

RSUBJID in DM.USUBJID

RSUBJID in POOLDEF.POOLID

RSUBJID = null

Describes relationship of associated person to study subject or pool

Describes relationship of associated person to device identified in RDEVID

Describes relationship of associated person to study identified in STUDYID

IDVAR ^= null

IDVAR = null

RDOMAIN ^= null

Comments are unsolicited, free-text and voluntary

CODTC = null

COVALn not present in dataset

SSDTC >= DM.DTHDTC

SSDTC >= all DS.DSSTDTC

The name of the variable is used as the value of FATESTCD.

FAOBJ in (--TERM, --TRT, --DECOD)

IEORRES = 'Y'

IEORRES = 'N'

IEORRES = 'N'
IESTRESC = IEORRES
IESTRESC = IEORRES

IETEST in TI.IETEST

IETESTCD in TI.IETESTCD

LBORNRLO = null
LBORNRLO = null

LBORNRHI = null

LBSTNRLO = null

LBSTNRHI = null

LBSTNRC = null

LBTOXGR is a numeric value

LBORNRLO in same units as LBORRESU
LBORNRLO in same units as LBORRESU
LBORNRHI in same units as LBORRESU
LBORNRHI in same units as LBORRESU

LBSTNRLO in same units as LBSTRESU

LBSTNRHI in same units as LBSTRESU

LBSTNRC in same units as LBSTRESU
LBSTNRC in same units as LBSTRESU

MB dataset present in study

MBTESTCD = 'ORGANISM'

MBRESCAT ^= null
PEORRES = 'NORMAL'

PEORRES = 'NORMAL'

PESTRESC = PEORRES OR a dictionary coded preferred term

Relationships represented in RELREC are collected relationships

Within a subject each unique RELID is present on multiple RELREC records

IDVAR ^= --SEQ

QEVAL ^= null

IDVAR ^= null
IDVAR ^= null

IDVARVAL ^= null

Suppqual dataset names <= 8 characters

TAETORD = null
TAETORD = null

SEENDTC = SESTDTC of next ELEMENT

SESTDTC ^= null

SEENDTC ^= null
SEENDTC ^= null

ETCD ^= 'UNPLAN'

ETCD = 'UNPLAN'

VISITNUM in TV.VISITNUM

VISITNUM not in TV.VISITNUM

VISITNUM not in TV.VISITNUM
VISIT in TV.VISIT
VISIT in TV.VISIT

VISITDY = null

TAETORD = SE.TAETORD

EPOCH = SE.EPOCH

At least one timing variable present in dataset

--STDY is properly calculated per study day algorithm

--STDY = null

--ENDY is properly calculated per study day algorithm

--ENDY = null

VISITDY = null

--STRF = null

--ENRF = null
--ENRF = null

--STRTPT in ('BEFORE', 'COINCIDENT', 'UNKNOWN')

--STRTPT in ('BEFORE', 'COINCIDENT', 'AFTER', 'UNKNOWN')

--ENRTPT in ('BEFORE', 'COINCIDENT', 'ONGOING', 'UNKNOWN')

--ENRTPT in ('BEFORE', 'COINCIDENT', 'ONGOING', 'AFTER', 'UNKNOWN')

--DTC is date/time of specimen collection or observation, not date/time of recording/acquisition

--DTC is date/time of recording/data acquisition

--ORRES in ISO 8601 date format

--TPT and --TPTNUM have a one-to-one relationship

--ELTM is the same value across records with the same values of DOMAIN, VISITNUM,
--TPTREF, and --TPTNUM
--ELTM is the same value across records with the same values of DOMAIN, VISITNUM,
--TPTREF, and --TPTNUM

ARM not in ('Screen Failure', 'Not Assigned', 'Unplanned Treatment', 'Not Treated')
ETCD value length <= 8
ETCD value length <= 8
TAETORD is unique within an ARM
TAETORD is unique within an ARM
TAETORD is an integer
TAETORD is an integer

TATRANS = null

TATRANS = null
Each value of EPOCH is not associated with more than one conceptual trial period
Each value of EPOCH is not associated with more than one conceptual trial period

TABRANCH ^= null

TATRANS ^= null

TIVERS ^= null

TIVERS present in dataset

IETESTCD unique within TIVERS

IETESTCD unique in dataset

TSPARMCD value length <= 8

TSPARM value length <= 40
TSPARM value length <= 40
TSVALNF ^= null
TSVALNF ^= null

TSVALNF = null

TSVAL ^= null

TSVALn ^= null

TSVALn ^= null
TSVALCD and TSVAL have a one-to-one relationship.
TSVALCD and TSVAL have a one-to-one relationship.
TSVCDREF ^= null
TSVCDREF ^= null
TSVCDVER ^= null
TSVCDVER ^= null
TSSEQ is unique for each distinct value of TSPARMCD
TSSEQ is unique for each distinct value of TSPARMCD

TSVAL in ('N','Y')

TSVAL conforms to ISO 8601

TSVAL in ('N','Y')

TSVAL = null or 'HEALTHY SUBJECTS'

TSVAL ^= null

TSVAL ^= null
TSVAL ^= null

TSVAL ^= null

TSVAL ^= null
TSVAL > 0 and TSVAL <= 1

TSVAL > 0 and TSVAL <= 1

TSPARMCD = RANDQT record is present

TSVAL in ('N','Y')

TSVAL conforms to ISO 8601 date

TSVAL is integer and > 0

TSVAL conforms to ISO 8601 date

A set of records exist with at least one record with TSPARMCD equal to each of the required
values in the list of Trial Summary Codes in Appendix C1

A set of records exist with at least one record with TSPARMCD equal to each of the required
values in the list of Trial Summary Codes in Appendix C1
TSVALCD = valid code in the version identified in TSVCDVER
TSVALCD = valid code in the version identified in TSVCDVER
TSVCDVER = valid published version (date)
TSVCDVER = valid published version (date)

TSVAL not populated with values or synonyms of values in the ISO 21090 null flavor codelist (or
other terms that can be represented as null flavors)

TSVAL ^= null

ARMCD in TA.ARMCD

ARM in TA.ARM
ARM in TA.ARM

ARMCD = null

ARM = null

ARMCD value length <= 20

VISIT is described in protocol
VISIT is described in protocol

TRLOC not present in dataset

TRLAT not present in dataset

TRDIR not present in dataset

TRPORTOT not present in dataset

Variable Label = IG Label

AEREASND not present in dataset

TSPARM and TSPARMCD have a one-to-one relationship
TSPARM and TSPARMCD have a one-to-one relationship

DOMAIN value length = 2

DOMAIN value length = 4
DOMAIN value length = 4

Variable name length <= 8

Variable label length <= 40

DOMAIN not in reserved or modeled standard

STUDYID, USUBJID or POOLID, DOMAIN, and --SEQ exist

Value of SUPP--.QNAM ^= any variable name defined in the corresponding SDTM version

PC dataset present in study

--TESTCD present in dataset

Custom domain is based on one of the observation classes

ELEMENT value does not refer to any specific ARM

ELEMENT value does not refer to any specific EPOCH

TEENRL value does not refer to any specific ARM

The combination of ELEMENT, TESTRL, TEENRL, and TEDUR is unique for each ETCD

TEENRL ^= null

TEDUR ^= null

Variables are ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables.
Within each role, variables are ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.3.1,
2.2.4, and 2.2.5
The first two characters of the dataset name must equal a domain that is present in the study

The first two characters of the dataset name must equal a domain that is present in the study

The characters of the dataset name after 'FA' equal a domain that present in the study

Value of RDOMAIN equals characters 5 and 6 of the dataset name

--CAT ^= Domain Name

--CAT ^= --DECOD

--SCAT ^= --DECOD

--SCAT ^= --DECOD
--CAT ^= --BODSYS

--CAT ^= --BODSYS

--SCAT ^= --BODSYS

--TESTCD ^= 'OTHER'

--TRT ^= 'OTHER'

--TERM ^= 'OTHER'

--TESTCD ^= 'MULTIPLE'

--TRT ^= 'MULTIPLE'
--TRT ^= 'MULTIPLE'

--TERM ^= 'MULTIPLE'

--ORRES ^ = 'MULTIPLE'

--ORRES ^= null

First 2 characters of the Variable Name = the 2-character domain code

--SCAT ^= Domain Name

Variables not in Model List of Allowed Variables for Observation Class are in SUPPQUAL
Variables not in Model List of Allowed Variables for Observation Class are in SUPPQUAL

--DTHREL not present in dataset

--EXCLFL not present in dataset

--REASEX not present in dataset

--DETECT not present in dataset

SPECIES not present in dataset

STRAIN not present in dataset

SBSTRAIN not present in dataset

Variable labels are in title case

POOLID = null
POOLID = null
USUBJID = null
USUBJID = null
RSUBJID ^= USUBJID

RSUBJID ^= USUBJID

RSUBJID ^= POOLID

RDEVID = null

RSUBJID = null

RSUBJID = DM.USUBJID

DM dataset present in study

RDOMAIN is dataset in study

IDVAR is variable in domain = RDOMAIN

IDVARVAL = value of variable = IDVAR in domain = RDOMAIN

--TESTCD <= 8 chars and contains only letters, numbers, and underscores and can not start
with a number
--TESTCD <= 8 chars and contains only letters, numbers, and underscores and can not start
with a number

Dataset present in study with DOMAIN = SUPP--.RDOMAIN

Dataset present in study with DOMAIN = RELREC.RDOMAIN
Dataset present in study with DOMAIN = RELREC.RDOMAIN

TDANCVAR = date variable name in ADSL

TDSTOFF = 0 or positive value in ISO 8601 Duration format

TDSTOFF = 0 or positive value in ISO 8601 Duration format
--LLT = MedDRA lowest level TERM
--LLT = MedDRA lowest level TERM
--LLTCD = MedDRA lowest level code
--LLTCD = MedDRA lowest level code

--DECOD = MedDRA preferred TERM

--PTCD = MedDRA preferred TERM code
--PTCD = MedDRA preferred TERM code
--HLT = MedDRA high level TERM
--HLT = MedDRA high level TERM
--HLTCD = MedDRA high level TERM code
--HLTCD = MedDRA high level TERM code
--HLGT = MedDRA high level group TERM
--HLGT = MedDRA high level group TERM
--HLGTCD = MedDRA high level group TERM code
--HLGTCD = MedDRA high level group TERM code

--BODSYS = MedDRA system organ class

--BDSYCD = MedDRA system organ class code

--SER in ('Y','N')
--SER in ('Y','N')

--SCAN in ('Y','N')

--SCONG in ('Y','N')

--SDISAB in ('Y','N')
--SDTH in ('Y','N')
--SHOSP in ('Y','N')
--SLIFE in ('Y','N')
--SOD in ('Y','N')
--SMIE in ('Y','N')

--CONTRT in ('Y','N')

--STRESC ^= null

At most one record per subject per epoch

--ULOQ is expressed using the units in --STRESU

--LOINC = valid code in the version of the LOINC dictionary specified in define.xml

--LOINC = valid code in the version of the LOINC dictionary specified in define.xml
--STAT present in dataset

--STAT present in dataset

--TEST length <= 40

EX present in study

Dataset > 0 records

STUDYID = DM.STUDYID
STUDYID = DM.STUDYID
VISITNUM identifies unique record within subject

VISITNUM identifies unique record within subject

IDVAR, IDVARVAL, and QNAM a unique combination per parent subject record

Subject records > 0

Dataset name begins with DOMAIN value

ETCD = TE.ETCD

ETCD = TE.ETCD
ARMCD is a valid planned arm code
ARMCD is a valid planned arm code

QLABEL value length <= 40

QNAM value length <=8 and cannot start with a number and cannot contain characters other
than letters in upper case, numbers, or underscores

TAETORD order of elements match order in TA within ARM of the Subject

RELTYPE = null

--STRF = null

--ENRF = null

--ENRF = null
--STAT = null
--STAT = null

--TRTV ^= null
--TRTV ^= null
--STRESU ^= null

--STRESU ^= null
--STRESC (in standard units) ^= null

--STRESC (in standard units) ^= null

--STRESC ^= null

--TOXGR ^= null

--TOXGR ^= null
--CAT ^= null

--CAT ^= null
--CAT present in dataset

--CAT present in dataset

Variable value ^= null

AGEU ^= null
AGEU ^= null
AGE ^= null
AGE ^= null
AGETXT ^= null
AGETXT ^= null
DTHFL = 'Y'

DTHFL = 'Y'
--SOC = MedDRA primary system organ class
--SOC = MedDRA primary system organ class
--SOCCD = MedDRA primary system organ class code
--SOCCD = MedDRA primary system organ class code

TSVAL conforms to ISO 8601 time period

TSVAL is integer and > 0

TSVAL ^= null

TSVAL is a valid preferred term from FDA Substance Registration System (SRS)

TSVALCD is a valid unique ingredient identifier from FDA Substance Registration System (SRS)

TSVCDREF = 'UNII'

TSVCDREF = 'UNII'
TSVAL is a valid preferred term from FDA Substance Registration System (SRS)

TSVAL is a valid preferred term from FDA Substance Registration System (SRS)

TSVALCD is a valid unique ingredient identifier from FDA Substance Registration System (SRS)

TSVAL is a valid term from SNOMED CT

TSVALCD is a valid concept identifier from SNOMED CT

TSVAL is a valid preferred term from FDA Substance Registration System (SRS)

TSVALCD is a valid unique ingredient identifier from FDA Substance Registration System (SRS)

TSVAL is a valid term from NDF-RT

TSVALCD is a valid code from NDF-RT

TSVCDREF = 'NDF-RT'
TSVCDREF = 'NDF-RT'

TSVCDREF = 'ISO 3166-1 alpha-3'

TSVAL is integer and > 0

TSVCDREF = 'SNOMED'

TSVALNF = null

TSVALNF = null
--HLT on path to MedDRA primary system organ class
--HLT on path to MedDRA primary system organ class
--HLGT on path to MedDRA primary system organ class
--HLGT on path to MedDRA primary system organ class

ECDOSTXT ^= null
ECDOSTXT ^= null

--TRT present in dataset

--TERM present in dataset

IDVARVAL = null

--LLOQ is expressed using the units in --STRESU

--STDTC not present

--TPTNUM present in dataset

TM must exist

TM must exist
MIDS present in dataset

--USCHFL not present in dataset

--IMPLBL not present in dataset

FETUSID not present in dataset

--NOMDY not present in dataset

--NOMLBL not present in dataset

ACTARMCD in TA.ARMCD

ARMNRS^=null

ACTARM in TA.ARM

ARMNRS^=null

ARMCD in TA.ARMCD

ARMNRS^=null

ARM in TA.ARM

ARMNRS^=null

ARMNRS = null

ARM = null

ACTARM = null

ARMCD = null

ACTARMCD = null
RACE = 'OTHER' or RACE = 'MULTIPLE'

RACE = 'UNKNOWN'

RACE = 'MULTIPLE'

ADSL Population flags not in SUPPDM

RFENDTC ^= null

RFENDTC = null

Multiple SUPPDM.QNAM records exist for the subject

RFSTDTC ^= null
RPATHCD not present in dataset
RFSTDTC = null

DSSCAT must be present

At most one record per subject per DSSCAT per epoch, including null values of DSSCAT

At most one record per subject per epoch

No more than 1 record per subject has DSSCAT = 'STUDY PARTICIPATION'

No more than 1 record per subject has DSSCAT = 'STUDY TREATMENT'

DS records present for subject

Value must be 'Y' or null

--BEATNO not present in dataset

--SEQ is in consistent chronological order

MIDSTYPE is unique per subject

MIDS is suffixed with a sequence number in consistent chronological order

SMSTDTC ^= null
--ORREF in same units as --ORRES

--STREFC ^= null

--STREFN ^= null

--STREFN in same units as --STRESN

--RESLOC not present in dataset

--ORRES ^= null

STUDYID, DOMAIN, and --SEQ exist and at least one of USUBJID, APID, SPDEVID, or
POOLID
Terminology is for non-normalized parameter (Codelist "PKUNIT")

Terminology is for parameter normalized by dose amount

Terminology is for parameter normalized by weight

Terminology is for non-normalized parameter

Terminology is for parameter normalized by dose amount

Terminology is for parameter normalized by weight
PESTRESC = null

--REPNUM ^= null and unique per subject per test per the timing variables

RSDRVFL = 'Y'

--AGENT not present in dataset

--CONC not present in dataset

--CONCU not present in dataset

--EVDTYP not present in dataset

EXMETHOD not present in dataset

--STRESC ^= null

ARM not in ('Screen Failure', 'Not Assigned', 'Unplanned Treatment', 'Not Treated')

--TPT and --TPTNUM have a one-to-one relationship per unique values of VISITNUM
--TPT and --TPTNUM have a one-to-one relationship per unique values of VISITNUM

--TPT and --TPTNUM have a one-to-one relationship per unique values of --TPTREF

--TPT and --TPTNUM have a one-to-one relationship per unique combination of VISITNUM and
–TPTREF values

--TPT and --TPTNUM have a one-to-one relationship per unique combination of VISITNUM and
–TPTREF values
Condition Document

Not custom domain IG v3.2

Not custom domain IG v3.3

--DUR ^= null Model v1.4

--DUR ^= null Model v1.7

Date portion of --DTC is complete and date portion of RFSTDTC is a complete

date AND --DY is ^= null IG v3.2

Date portion of --DTC is complete and date portion of RFSTDTC is a complete

date AND --DY is ^= null IG v3.3

The date portion of --DTC ^= complete date or the date portion of

DM.RFSTDTC ^= complete date IG v3.2

The date portion of --DTC ^= complete date or the date portion of

DM.RFSTDTC ^= complete date IG v3.3

--TPTREF = null Model v1.4

--TPTREF = null Model v1.7

IG v3.2
IG v3.3

IG v3.2|Model v1.4

IG v3.3

IG v3.2

IG v3.3

IG v3.2|Model v1.4

IG v3.3|Model v1.7

IG v3.2|Model v1.4

IG v3.3|Model v1.7

Variable Core Status = Required IG v3.2

Variable Core Status = Required IG v3.3

Variable Core Status = Permissible and data is collected IG v3.2

Variable Core Status = Permissible and data is collected IG v3.3

Variable Core Status = Expected IG v3.2

Variable Core Status = Expected IG v3.3

Non-Supplemental Qualifier datasets IG v3.2

Non-Supplemental Qualifier datasets IG v3.3

Supplemental Qualifier datasets IG v3.2

Supplemental Qualifier datasets IG v3.3

IG v3.2

IG v3.3

Use of value 'MULTIPLE' is appropriate to the data being represented IG v3.2

Use of value 'MULTIPLE' is appropriate to the data being represented IG v3.3

Variable associated with extensible codelist and the use of value 'OTHER' is
appropriate to the data being represented IG v3.2

Variable associated with extensible codelist and the use of value 'OTHER' is
appropriate to the data being represented IG v3.3
--LNKGRP present in a domain IG v3.2

--LNKGRP present in a domain IG v3.3

--LNKID present in a domain IG v3.2

--LNKID present in a domain IG v3.3

--TPTREF = null Model v1.4

--TPTREF = null Model v1.7
--SCAT ^= null Model v1.4
--SCAT ^= null Model v1.7

Variable is not TS.TSSEQ Model v1.4

Variable is not TS.TSSEQ Model v1.7

Domain Not in ('AP--') IG v3.2

Domain Not in ('AP--') IG v3.3

VISIT ^= null and is planned IG v3.2

VISIT ^= null and is planned IG v3.3

VISITNUM is in TV.VISITNUM IG v3.2

VISITNUM is in TV.VISITNUM IG v3.3

VISITNUM ^= null and is planned IG v3.2

VISITNUM ^= null and is planned IG v3.3

VISITNUM ^= null IG v3.2

VISITNUM ^= null IG v3.3

VISITNUM in TV.VISITNUM IG v3.2

VISITNUM in TV.VISITNUM IG v3.3

Primary SOC used for analysis IG v3.2|Model v1.4

Primary SOC used for analysis IG v3.3|Model v1.7

Primary SOC used for analysis IG v3.2|Model v1.4

Primary SOC used for analysis IG v3.3|Model v1.7

IG v3.2

IG v3.3

AESCAN = 'Y' or AESCONG = 'Y' or AESDISAB = 'Y' or AESDTH = 'Y' or

AESHOSP = 'Y' or AESLIFE = 'Y' or AESOD = 'Y' or AESMIE = 'Y' IG v3.2

AESCAN = 'Y' or AESCONG = 'Y' or AESDISAB = 'Y' or AESDTH = 'Y' or

AESHOSP = 'Y' or AESLIFE = 'Y' or AESOD = 'Y' or AESMIE = 'Y' IG v3.3

AESCAN ^= 'Y' and AESCONG ^= 'Y' and AESDISAB ^= 'Y' and AESDTH ^=
'Y' and AESHOSP ^= 'Y' and AESLIFE ^= 'Y' and AESOD ^= 'Y' and AESMIE
^= 'Y' IG v3.2
AESCAN ^= 'Y' and AESCONG ^= 'Y' and AESDISAB ^= 'Y' and AESDTH ^=
'Y' and AESHOSP ^= 'Y' and AESLIFE ^= 'Y' and AESOD ^= 'Y' and AESMIE
^= 'Y' IG v3.3

Record present in SUPPAE where SUPPAE.QNAM=AESOSP IG v3.2

Record present in SUPPAE where SUPPAE.QNAM=AESOSP IG v3.3

IG v3.2

IG v3.3

--ENTPT ^= null Model v1.4

--ENTPT ^= null Model v1.7

--ENRTPT ^= null Model v1.4

--ENRTPT ^= null Model v1.7

--TERM modified for coding Model v1.4

--TERM modified for coding Model v1.7

Model v1.4

Model v1.7
--PTCD ^= null Model v1.4
--PTCD ^= null Model v1.7

--PRESP not present in dataset Model v1.4

--PRESP not present in dataset Model v1.7

--PRESP not present in dataset Model v1.4

--PRESP not present in dataset Model v1.7

--ENTPT present in dataset Model v1.4

--ENTPT present in dataset Model v1.7

--ENRTPT present in dataset Model v1.4

--ENRTPT present in dataset Model v1.7

--STTPT ^= null Model v1.4

--STTPT ^= null Model v1.7

--STTPT present in dataset Model v1.4

--STTPT present in dataset Model v1.7

--STRTPT ^= null Model v1.4

--STRTPT ^= null Model v1.7

--STRTPT present in dataset Model v1.4

--STRTPT present in dataset Model v1.7

Multiple events per subject where DSCAT = 'DISPOSITION EVENT' IG v3.2
DSTERM = 'COMPLETED' IG v3.2
DSTERM = 'COMPLETED' IG v3.3

DSCAT = 'PROTOCOL MILESTONE' IG v3.2

SS.SSSTRESC = 'DEAD' IG v3.2

SS.SSSTRESC = 'DEAD' IG v3.3

Multiple informed consents obtained and DSDECOD = 'INFORMED CONSENT

OBTAINED' IG v3.2

Multiple informed consents obtained and DSDECOD = 'INFORMED CONSENT

OBTAINED' IG v3.3

DSDECOD = 'DEATH' IG v3.2

DSDECOD = 'DEATH' IG v3.3

DSCAT = 'DISPOSITION EVENT' IG v3.2

DSCAT = 'DISPOSITION EVENT' IG v3.3

DSCAT = 'PROTOCOL MILESTONE' IG v3.2

IG v3.2
IG v3.3

IG v3.2

IG v3.3

MHCAT ^= null IG v3.2

MHCAT ^= null IG v3.3

MHENDTC ^= null IG v3.2

MHENDTC ^= null IG v3.3

MHSTDTC ^= null IG v3.2

MHSTDTC ^= null IG v3.3

--PRESP = 'Y' and --OCCUR = null Model v1.4

--PRESP = 'Y' and --OCCUR = null Model v1.7
--BDSYCD ^= null Model v1.4
--BDSYCD ^= null Model v1.7
Model v1.4
Model v1.7
--TOXGR not present in dataset Model v1.4
--TOXGR not present in dataset Model v1.7

Model v1.4

Model v1.7

--PRESP = 'Y' and --STAT = null and --OCCUR is present in dataset Model v1.4

--PRESP = 'Y' and --STAT = null and --OCCUR is present in dataset Model v1.7
(--PRESP ^= 'Y' and --OCCUR is present in dataset) or (--STAT=NOT DONE) Model v1.4

(--PRESP ^= 'Y' and --OCCUR is present in dataset) or (--STAT=NOT DONE) Model v1.7

--PRESP not present in dataset Model v1.4

--PRESP not present in dataset Model v1.7

--OCCUR ^= null Model v1.4

--OCCUR ^= null Model v1.7

--RFTDTC present in dataset Model v1.4

--RFTDTC present in dataset Model v1.7

--ELTM present in dataset Model v1.4|IG v3.2

--ELTM present in dataset Model v1.7|IG v3.3

--ELTM, --TPTNUM, and --TPT not present in dataset Model v1.4

--ELTM, --TPTNUM, and --TPT not present in dataset Model v1.7

--REASND ^= null Model v1.4

--REASND ^= null Model v1.7

--LOC not present in dataset Model v1.4
--LOC not present in dataset Model v1.7
CMTRT has a decode value in the dictionary IG v3.2

CMTRT has a decode value in the dictionary IG v3.3

IG v3.2
IG v3.3

IG v3.2

IG v3.3

--TRT modified Model v1.4

--TRT modified Model v1.7

ECOCCUR ^= 'N' and ECSTAT is null and ECDOSTXT is null IG v3.2

ECOCCUR ^= 'N' and ECSTAT is null and ECDOSTXT is null IG v3.3

ECOCCUR = 'N' IG v3.2

ECOCCUR = 'N' IG v3.3

EXTRT = 'PLACEBO' IG v3.2

EXTRT = 'PLACEBO' IG v3.3

IG v3.2
IG v3.3

IG v3.2

IG v3.3

EC domain is present IG v3.2

EC domain is present IG v3.3

--TRTV = null Model v1.4

--TRTV = null Model v1.7

EC domain is present IG v3.2

EC domain is present IG v3.3

--TRTV = null Model v1.4

--TRTV = null Model v1.7

No records in EX for Subject IG v3.2

--DOSTXT ^= null Model v1.4
--DOSTXT ^= null Model v1.7

--DOSE ^= null IG v3.2

--DOSE ^= null Model v1.7

Model v1.4

Model v1.7
--DOSE ^= null or --DOSTOT ^= null or --DOSTXT ^= null Model v1.4
--DOSE ^= null or --DOSTOT ^= null or --DOSTXT ^= null Model v1.7

--LOC not present in dataset Model v1.4

--LOC not present in dataset Model v1.7

--LOC not present in dataset Model v1.4

--LOC not present in dataset Model v1.7

ACTARM not in TA.ARM IG v3.2

ACTARM not in ('Screen Failure', 'Not Assigned', 'Not Treated', 'Unplanned
Treatment') IG v3.2

ACTARM in ('Screen Failure', 'Not Assigned') IG v3.2

ARM not in TA.ARM IG v3.2
ARM not in ('Screen Failure', 'Not Assigned') IG v3.2

ARM in ('Screen Failure', 'Not Assigned') IG v3.2

IG v3.2

IG v3.3

ACTARMCD not in TA.ARMCD IG v3.2

ACTARMCD not in ('SCRNFAIL', 'NOTASSGN', 'NOTTRT', 'UNPLAN') IG v3.2

ARMCD not in ('SCRNFAIL', 'NOTASSGN') IG v3.2

ACTARMCD in ('SCRNFAIL', 'NOTASSGN') IG v3.2

ARMCD not in TA.ARMCD IG v3.2

ARMCD in ('SCRNFAIL', 'NOTASSGN') IG v3.2

Model v1.4
Model v1.7

SS.SSSTRESC = 'DEAD' IG v3.2

SS.SSSTRESC = 'DEAD' IG v3.3

DD record present for subject IG v3.2

DD record present for subject IG v3.3

AE.AEOUT = 'FATAL' IG v3.2

AE.AEOUT = 'FATAL' IG v3.3

AE.AESDTH = 'Y' IG v3.2

AE.AESDTH = 'Y' IG v3.3

DS.DSDECOD = 'DEATH' IG v3.2

DS.DSDECOD = 'DEATH' IG v3.3

Population flags included in submission IG v3.2

Multiple records in SUPPDM where RACE captured IG v3.2

Milestone associated with RFENDTC is end of treatment and ACTARM in

('Screen Failure', 'Not Assigned', 'Not Treated') IG v3.2
Milestone associated with RFENDTC is end of treatment and ACTARM not in
(‘Screen Failure’, ‘Not Assigned’, ‘Not Treated’) IG v3.2

DS.DSTERM indicates informed consent obtained IG v3.2

DS.DSTERM indicates informed consent obtained IG v3.3

Milestone associated with RFSTDTC is start of treatment and ACTARM in
('Screen Failure' 'Not Assigned' 'Not Treated') IG v3.2
Milestone associated with RFSTDTC is start of treatment and ACTARM not in
('Screen Failure' 'Not Assigned' 'Not Treated') IG v3.2

EX records present for subject IG v3.2

EX records present for subject IG v3.3

EX dataset present in study IG v3.2

EX dataset present in study IG v3.3

Model v1.4
Model v1.7
IG v3.2
IG v3.3
IG v3.2
IG v3.3

ETCD = 'UNPLAN' IG v3.2

ETCD = 'UNPLAN' IG v3.3

IG v3.2

IG v3.3

ELEMENT present in dataset and ETCD present in dataset IG v3.2

ELEMENT present in dataset and ETCD present in dataset IG v3.3

AP Core Domain AP Guide v1.0

APID identifies group of associated persons defined in POOLDEF AP Guide v1.0

Relationship described is to a study subject AP Guide v1.0

Relationship described is to a pool AP Guide v1.0

Relationship described is to a study but not to individual study subjects AP Guide v1.0

RSUBJID ^= null AP Guide v1.0

RDEVID ^= null AP Guide v1.0

RSUBJID = null and RDEVID = null AP Guide v1.0

Comment related to Domain Records and RDOMAIN not in (null, 'DM') IG v3.2

Comment related to Domain Records and RDOMAIN not in (null, 'DM') IG v3.3

RDOMAIN = null IG v3.2

RDOMAIN = null IG v3.3

IDVARVAL ^= null IG v3.2

IDVARVAL ^= null IG v3.3

IG v3.2
IG v3.3

IDVAR ^= null IG v3.2

IDVAR ^= null IG v3.3

No comment > 200 characters IG v3.2

No comment > 200 characters IG v3.3

SSSTRESC = 'DEAD' IG v3.2

SSSTRESC = 'DEAD' IG v3.3

SSSTRESC = 'DEAD' IG v3.2

SSSTRESC = 'DEAD' IG v3.3

Collected data fit a Qualifier variable listed in SDTM: Sections 2.2.1, 2.2.2, or
2.2.3, and are represented in the Findings About domain IG v3.2

Collected data fit a Qualifier variable listed in SDTM: Sections 2.2.1, 2.2.2, or
2.2.3, and are represented in the Findings About domain IG v3.3

Related record present in parent domain dataset IG v3.2

Related record present in parent domain dataset IG v3.3

IECAT = 'EXCLUSION' IG v3.2

IECAT = 'EXCLUSION' IG v3.3

IECAT = 'INCLUSION' IG v3.2

IECAT = 'INCLUSION' IG v3.3

IG v3.2
IG v3.3

IG v3.2

IG v3.3

IG v3.2

IG v3.3

LBORRES ^= continuous measurement IG v3.2

LBORRES ^= continuous measurement IG v3.3

LBORRES ^= continuous measurement IG v3.2

LBORRES ^= continuous measurement IG v3.3

LBORRES ^= continuous measurement IG v3.2

LBORRES ^= continuous measurement IG v3.3

LBORRES ^= continuous measurement IG v3.2

LBORRES ^= continuous measurement IG v3.3

LBORRES = continuous measurement IG v3.2

LBORRES = continuous measurement IG v3.3

Numeric scale used IG v3.2

Numeric scale used IG v3.3

IG v3.2
IG v3.3
IG v3.2
IG v3.3

IG v3.2

IG v3.3

IG v3.2

IG v3.3
LBSTRESU ^= null IG v3.2
LBSTRESU ^= null IG v3.3

MS dataset present in study IG v3.2

MS dataset present in study IG v3.3

Organisms present in the specimen IG v3.2

MBTESTCD = 'ORGANISM' and MBSTRESC ^= 'NO GROWTH' and

MBMETHOD ^= 'GRAM STAIN' IG v3.2
PEORRES ^= null and no abnormal findings IG v3.2

PEORRES ^= null and no abnormal findings IG v3.3

PESTRESC ^= null IG v3.2

PESTRESC ^= null IG v3.3

IG v3.2

IG v3.3

IG v3.2

IG v3.3

IDVARVAL = null and USUBJID = null IG v3.2

IDVARVAL = null and USUBJID = null IG v3.3

QORIG = 'Assigned' IG v3.2

QORIG = 'Assigned' IG v3.3

RDOMAIN ^= 'DM' IG v3.2

RDOMAIN ^= 'DM' IG v3.3

IDVAR ^= null IG v3.2

IDVAR ^= null IG v3.3

IG v3.2

IG v3.3

ETCD = 'UNPLAN' IG v3.2

ETCD = 'UNPLAN' IG v3.3

Next ELEMENT present in dataset IG v3.2

Next ELEMENT present in dataset IG v3.3

IG v3.2

IG v3.3

Not last record IG v3.2

Not last record IG v3.3

SEUPDES = null IG v3.2

SEUPDES = null IG v3.3

SEUPDES ^= null IG v3.2

SEUPDES ^= null IG v3.3

SVUPDES = null IG v3.2

SVUPDES = null IG v3.3

SVUPDES ^= null IG v3.2

SVUPDES ^= null IG v3.3
SVUPDES = null IG v3.2
SVUPDES = null IG v3.3

SVUPDES ^= null IG v3.2

SVUPDES ^= null IG v3.3

TAETORD present in dataset and SESTDTC <= SVSTDTC and SVSTDTC <=
SEENDTC IG v3.2

TAETORD present in dataset and SESTDTC <= SVSTDTC and SVSTDTC <=
SEENDTC IG v3.3

EPOCH present in dataset and SESTDTC <= SVSTDTC and SVSTDTC <=
SEENDTC IG v3.2

EPOCH present in dataset and SESTDTC <= SVSTDTC and SVSTDTC <=
SEENDTC IG v3.3

IG v3.2

IG v3.3
--STDTC and DM.RFSTDTC both contain complete values in their date portion IG v3.2

--STDTC and DM.RFSTDTC both contain complete values in their date portion IG v3.3

--STDTC or DM.RFSTDTC does not contain complete values in their date

portion IG v3.2

--STDTC or DM.RFSTDTC does not contain complete values in their date

portion IG v3.3

--ENDTC and DM.RFSTDTC both contain complete values in their date portion IG v3.2
--ENDTC and DM.RFSTDTC both contain complete values in their date portion IG v3.3

--ENDTC or DM.RFSTDTC does not contain complete values in their date

portion IG v3.2

--ENDTC or DM.RFSTDTC does not contain complete values in their date

portion IG v3.3

VISITNUM is NOT in TV.VISITNUM IG v3.2

VISITNUM is NOT in TV.VISITNUM IG v3.3

DM.RFSTDTC = null Model v1.4

DM.RFSTDTC = null Model v1.7

DM.RFENDTC = null Model v1.4

DM.RFENDTC = null Model v1.7

--STTPT corresponds to the date of collection or assessment. IG v3.2

--STTPT corresponds to the date of collection or assessment. IG v3.3

--STTPT is prior to the date of collection or assessment. IG v3.2

--STTPT is prior to the date of collection or assessment. IG v3.3

--ENTPT corresponds to the date of collection or assessment. IG v3.2

--ENTPT corresponds to the date of collection or assessment. IG v3.3

--ENTPT is prior to the date of collection or assessment. IG v3.2

--ENTPT is prior to the date of collection or assessment. IG v3.3

IG v3.2

IG v3.3

--DTC present in dataset IG v3.2

--DTC present in dataset IG v3.3

Date Value IG v3.2

Date Value IG v3.3

VISITNUM and --TPTREF are not present in dataset IG v3.2

VISITNUM and --TPTREF are not present in dataset IG v3.3

--TPT ^= null and --TPTNUM ^= null and --ELTM ^= null IG v3.2

--TPT ^= null and --TPTNUM ^= null and --ELTM ^= null IG v3.3

IG v3.2
IG v3.2
IG v3.3
IG v3.2
IG v3.3
IG v3.2
IG v3.3
Element does not end with a decision that could lead to a shortened path within
the Arm IG v3.2
Element does not end with a decision that could lead to a shortened path within
the Arm IG v3.3
IG v3.2
IG v3.3

Trial design branches IG v3.2

Trial design branches IG v3.3

Trial Design allows for a Subject to transition to an Element other than the next
Element in sequence IG v3.2

Trial Design allows for a Subject to transition to an Element other than the next
Element in sequence IG v3.3

Greater than one version of the IE criteria in study documentation IG v3.2

Greater than one version of the IE criteria in study documentation IG v3.3

Greater than one version of the IE criteria IG v3.2

Greater than one version of the IE criteria IG v3.3

TIVERS present in dataset IG v3.2

TIVERS present in dataset IG v3.3

TIVERS not present in dataset IG v3.2

TIVERS not present in dataset IG v3.3

IG v3.2

IG v3.3
IG v3.2
IG v3.3
TSVAL = null IG v3.2
TSVAL = null IG v3.3

TSVAL ^= null IG v3.2

TSVAL ^= null IG v3.3

TSVAL1 ^= null IG v3.2

TSVAL1 ^= null IG v3.3

TSVAL(n+1) ^= null IG v3.2

TSVAL(n+1) ^= null IG v3.3

TSVAL ^= null and TSVALCD ^= null IG v3.2
TSVAL ^= null and TSVALCD ^= null IG v3.3
TSVCDVER ^= null IG v3.2
TSVCDVER ^= null IG v3.3
Reference Terminology is versioned. IG v3.2
Reference Terminology is versioned. IG v3.3
TSPARMCD not unique IG v3.2
TSPARMCD not unique IG v3.3

TSPARMCD = 'ADDON' and TSVAL ^= null IG v3.2

TSPARMCD = 'ADDON' and TSVAL ^= null IG v3.3

TSPARMCD = 'AGEMAX' and TSVAL ^= null IG v3.2

TSPARMCD = 'AGEMAX' and TSVAL ^= null IG v3.3

TSPARMCD = 'RANDOM' and TSVAL ^= null IG v3.2

TSPARMCD = 'RANDOM' and TSVAL ^= null IG v3.3

TSPARMCD = 'TDIGRP' and record exists where TSPARMCD = 'HLTSUBJI'

and TSVAL = 'Y' IG v3.2

TSPARMCD = 'TDIGRP' and record exists where TSPARMCD = 'HLTSUBJI'

and TSVAL = 'Y' IG v3.3

TSPARMCD = 'TDIGRP' and record exists where TSPARMCD = 'HLTSUBJI'

and TSVAL = 'N' IG v3.2

TSPARMCD = 'TDIGRP' and record exists where TSPARMCD = 'HLTSUBJI'

and TSVAL = 'N' IG v3.3

TSPARMCD = 'CURTRT' and record exists where TSPARMCD = 'ADDON' and

TSVAL = 'Y' IG v3.2
TSPARMCD = 'CURTRT' and record exists where TSPARMCD = 'ADDON' and
TSVAL = 'Y' IG v3.3

TSPARMCD = 'TRT' and record exists where TSPARMCD = 'STYPE' and

TSVAL = 'INTERVENTIONAL' IG v3.2

TSPARMCD = 'TRT' and record exists where TSPARMCD = 'STYPE' and

TSVAL = 'INTERVENTIONAL' IG v3.3

TSPARMCD = 'INTMODEL' and record exists where TSPARMCD = 'STYPE'

and TSVAL = 'INTERVENTIONAL' IG v3.2

TSPARMCD = 'INTMODEL' and record exists where TSPARMCD = 'STYPE'

and TSVAL = 'INTERVENTIONAL' IG v3.3

TSPARMCD = 'INTTYPE' and record exists where TSPARMCD = 'STYPE' and

TSVAL = 'INTERVENTIONAL' IG v3.2

TSPARMCD = 'INTTYPE' and record exists where TSPARMCD = 'STYPE' and

TSVAL = 'INTERVENTIONAL' IG v3.3

TSPARMCD = 'PCLAS' and record exists where TSPARMCD = 'STYPE' and

TSVAL = 'INTERVENTIONAL' and Pharmacological Class of Interventional
Therapy is applicable IG v3.2

TSPARMCD = 'PCLAS' and record exists where TSPARMCD = 'STYPE' and

TSVAL = 'INTERVENTIONAL' and Pharmacological Class of Interventional
Therapy is applicable IG v3.3
TSPARMCD = 'RANDQT' and TSVAL ^= null IG v3.2

TSPARMCD = 'RANDQT' and TSVAL ^= null IG v3.3

At least one observation where TSPARMCD = TRT and there is only one
investigational treatment IG v3.2

At least one observation where TSPARMCD = TRT and there is only one
investigational treatment IG v3.3

TSPARMCD = ADAPT IG v3.2

TSPARMCD = ADAPT IG v3.3

TSPARMCD = DCUTDTC IG v3.2

TSPARMCD = DCUTDTC IG v3.3

TSPARMCD = NARMS IG v3.2

TSPARMCD = NARMS IG v3.3

TSPARMCD = SSTDTC IG v3.2

TSPARMCD = SSTDTC IG v3.3

TSPARMCD = SENDTC IG v3.2

TSPARMCD = SENDTC IG v3.3

IG v3.2

IG v3.3
TSVCDREF = 'CDISC' IG v3.2
TSVCDREF = 'CDISC' IG v3.3
TSVCDREF = 'CDISC' IG v3.2
TSVCDREF = 'CDISC' IG v3.3

TSVALNF = null IG v3.2

TSVALNF = null IG v3.3

TSPARMCD equals one of the values in the list of Trial Summary Codes in
Appendix C1 and TSVALNF is null IG v3.2

TSPARMCD equals one of the values in the list of Trial Summary Codes in
Appendix C1 and TSVALNF is null IG v3.3

ARMCD ^= null IG v3.2

ARMCD ^= null IG v3.3

ARM ^= null IG v3.2

ARM ^= null IG v3.3
The timing and number of Visits for a trial does not depend on which ARM a
subject is in IG v3.2
The timing and number of Visits for a trial does not depend on which ARM a
subject is in IG v3.3
The timing and number of Visits for a trial does not depend on which ARM a
subject is in IG v3.2
The timing and number of Visits for a trial does not depend on which ARM a
subject is in IG v3.3

IG v3.2

IG v3.3
IG v3.2
IG v3.3

IG v3.2

IG v3.3

IG v3.2

IG v3.3

IG v3.2

IG v3.3

IG v3.2

IG v3.3

IG v3.2
IG v3.2

IG v3.3
IG v3.2
IG v3.3

IG v3.2

IG v3.3
IG v3.2
IG v3.3

IG v3.2

IG v3.3

IG v3.2

IG v3.3

Custom domain present in study IG v3.2

Custom domain present in study IG v3.3

Model v1.4

SUPP--.QNAM present in dataset IG v3.2

SUPP--.QNAM present in dataset IG v3.3|Model v1.7

PP dataset present in study IG v3.2

PP dataset present in study IG v3.3

Custom domain present in study IG v3.2

Custom domain present in study IG v3.3

Custom domain present in study IG v3.2

Custom domain present in study IG v3.3

ELEMENT is associated with > 1 ARM IG v3.2

ELEMENT is associated with > 1 ARM IG v3.3

ELEMENT is associated with > 1 EPOCH IG v3.2

ELEMENT is associated with > 1 EPOCH IG v3.3

IG v3.2

IG v3.3

IG v3.2

IG v3.3

TEDUR = null IG v3.2

TEDUR = null IG v3.3

TEENRL = null IG v3.2

TEENRL = null IG v3.3

IG v3.2

IG v3.3
Dataset name length = 3 or 4 and dataset name does not begin with 'AP' or 'FA' IG v3.2

Dataset name length = 3 or 4 and dataset name does not begin with 'AP' or 'FA' IG v3.3

Dataset split by parent domain and dataset name length > 2 and dataset name
begins with 'FA' IG v3.2

Dataset split by parent domain and dataset name length > 2 and dataset name
begins with 'FA' IG v3.3

Dataset name begins with 'SUPP' IG v3.2

Dataset name begins with 'SUPP' IG v3.3

IG v3.2

IG v3.3

IG v3.2

IG v3.3

IG v3.2

IG v3.3
IG v3.2

IG v3.3

IG v3.2

IG v3.3

IG v3.2

IG v3.3

IG v3.2

IG v3.3

IG v3.2

IG v3.3

IG v3.2

IG v3.3

IG v3.2
IG v3.3

IG v3.2

IG v3.3

The use of 'MULTIPLE' reflects multiple values (as opposed to a valid response
in the context of the finding (e.g., Questionnaire CT). IG v3.2

The use of 'MULTIPLE' reflects multiple values (as opposed to a valid response
in the context of the finding (e.g., Questionnaire CT). IG v3.3

--STAT = null or --DRVFL ^= 'Y' IG v3.2

--STAT = null or --DRVFL ^= 'Y' IG v3.3

Custom domain and variable name is not STUDYID, DOMAIN, USUBJID,

POOLID, SPDEVID, VISIT, VISITNUM, VISITDY, ELEMENT, TAETORD,
EPOCH. IG v3.2
Custom domain and variable name is not STUDYID, DOMAIN, USUBJID,
POOLID, SPDEVID, VISIT, VISITNUM, VISITDY, ELEMENT, TAETORD,
EPOCH. IG v3.3

IG v3.2

IG v3.3
IG v3.2
IG v3.3

IG v3.2

IG v3.3

IG v3.2

IG v3.3

IG v3.2

IG v3.3

IG v3.2
IG v3.3

IG v3.2

IG v3.3

IG v3.2

IG v3.3

IG v3.2

IG v3.3

IG v3.2

IG v3.3
USUBJID ^= null Model v1.4
USUBJID ^= null Model v1.7
POOLID ^= null Model v1.4
POOLID ^= null Model v1.7
RSUBJID ^= null Model v1.4

RSUBJID ^= null Model v1.7

RSUBJID ^= null Model v1.4

RSUBJID ^= null Model v1.7

RSUBJID ^= null Model v1.4

RSUBJID ^= null Model v1.7

RDEVID ^= null Model v1.4

RDEVID ^= null Model v1.7

RSUBJID ^=null and RSUBJID ^= POOLID Model v1.4

RSUBJID ^=null and RSUBJID ^= POOLID Model v1.7

Study on human subjects Model v1.4

Study on human subjects Model v1.7

RDOMAIN ^= null Model v1.4

RDOMAIN ^= null Model v1.7

IDVAR ^= null Model v1.4

IDVAR ^= null Model v1.7

IDVAR ^= null Model v1.4

IDVAR ^= null Model v1.7

IG v3.2|Model v1.4
IG v3.3|Model v1.7

SUPP-- dataset present in study IG v3.2

SUPP-- dataset present in study IG v3.3

RELREC dataset present in study Model v1.4
RELREC dataset present in study Model v1.7

IG v3.2|Model v1.4

IG v3.3|Model v1.7

IG v3.2|Model v1.4
IG v3.3|Model v1.7
Model v1.4
Model v1.7
Model v1.4
Model v1.7

--DECOD ^= null Model v1.4

--DECOD ^= null Model v1.7

Model v1.4
Model v1.7
Model v1.4
Model v1.7
Model v1.4
Model v1.7
Model v1.4
Model v1.7
Model v1.4
Model v1.7

Model v1.4

Model v1.7

Model v1.4

Model v1.7
--SER ^= null Model v1.4
--SER ^= null Model v1.7

--SCAN ^= null Model v1.4

--SCONG ^= null Model v1.4

--SDISAB ^= null Model v1.4

--SDTH ^= null Model v1.4
--SHOSP ^= null Model v1.4
--SLIFE ^= null Model v1.4
--SOD ^= null Model v1.4
--SMIE ^= null Model v1.4

--CONTRT ^= null Model v1.4

--CONTRT ^= null Model v1.7

--ORRES ^= null or --DRVFL = 'Y' IG v3.2|Model v1.4

--ORRES ^= null or --DRVFL = 'Y' IG v3.3|Model v1.7

DSCAT = 'DISPOSITION EVENT' IG v3.2

--ULOQ present in dataset Model v1.4

--ULOQ present in dataset Model v1.7

Model v1.4

Model v1.7
--PRESP = 'Y' and --OCCUR = null Model v1.4

--PRESP = 'Y' and --OCCUR = null Model v1.7

IG v3.2

IG v3.3

Study includes protocol-specified study treatment IG v3.2

Study includes protocol-specified study treatment IG v3.3

Dataset planned for submission IG v3.2

Dataset planned for submission IG v3.3

IG v3.2
IG v3.3
Scheduled or Contingent visit (exists in TV) IG v3.2

Scheduled or Contingent visit (exists in TV) IG v3.3

IG v3.2

IG v3.3

DM.ACTARMCD not in ('SCRNFAIL', 'NOTASSGN', 'NOTTRT') IG v3.2

Model v1.4

Model v1.7

ETCD ^= 'UNPLAN' IG v3.2

ETCD ^= 'UNPLAN' IG v3.3

IG v3.2
IG v3.3

Model v1.4

Model v1.7
Model v1.4

Model v1.7

Model v1.4

Model v1.7

IDVAR populated with a --SEQ value IG v3.2

IDVAR populated with a --SEQ value IG v3.3

--OCCUR = 'N' Model v1.4

--OCCUR = 'N' Model v1.7

--OCCUR = 'N' Model v1.4

--OCCUR = 'N' Model v1.7

--ORRES ^= null IG v3.2
--ORRES ^= null IG v3.3

--VAMT ^= null Model v1.4

--VAMT ^= null Model v1.7
--STRESC ^= null and units are applicable for the result Model v1.4

--STRESC ^= null and units are applicable for the result Model v1.7
--STRESU ^= null Model v1.4

--STRESU ^= null Model v1.7

--RESCAT ^= null Model v1.4

--RESCAT ^= null Model v1.7

--TOX ^= null Model v1.4

--TOX ^= null Model v1.7

--SCAT ^= null Model v1.4

--SCAT ^= null Model v1.7

--SCAT present in dataset Model v1.4

--SCAT present in dataset Model v1.7

Variable Core Status = Expected and data collected IG v3.2

Variable Core Status = Expected and data collected IG v3.3

AGE ^= null or AGETXT ^= null Model v1.4
AGE ^= null or AGETXT ^= null Model v1.7
AGEU ^= null and AGETXT = null Model v1.4
AGEU ^= null and AGETXT = null Model v1.7
AGEU ^= null and AGE = null Model v1.4
AGEU ^= null and AGE = null Model v1.7
DTHDTC ^= null Model v1.4

DTHDTC ^= null Model v1.7

Model v1.4
Model v1.7
Model v1.4
Model v1.7

TSPARMCD = 'AGEMIN' and TSVAL ^= null IG v3.2

TSPARMCD = 'AGEMIN' and TSVAL ^= null IG v3.3

TSPARMCD = 'LENGTH' and TSVAL ^= null IG v3.2

TSPARMCD = 'LENGTH' and TSVAL ^= null IG v3.3

TSPARMCD = 'PLANSUB' IG v3.2

TSPARMCD = 'PLANSUB' IG v3.3

TSPARMCD = 'STOPRULE' IG v3.2

TSPARMCD = 'STOPRULE' IG v3.3

TSPARMCD = 'CURTRT' IG v3.2

TSPARMCD = 'CURTRT' IG v3.3

TSPARMCD = 'CURTRT' IG v3.2

TSPARMCD = 'CURTRT' IG v3.3

TSPARMCD in ('COMPTRT', 'CURTRT', 'TRT') IG v3.2

TSPARMCD in ('COMPTRT', 'CURTRT', 'TRT') IG v3.3

TSPARMCD = 'COMPTRT' IG v3.2

TSPARMCD = 'COMPTRT' IG v3.3

TSPARMCD = 'COMPTRT' IG v3.2

TSPARMCD = 'COMPTRT' IG v3.3

TSPARMCD in ('INDIC', 'TDIGRP') IG v3.2

TSPARMCD in ('INDIC', 'TDIGRP') IG v3.3

TSPARMCD in ('INDIC', 'TDIGRP') IG v3.2

TSPARMCD in ('INDIC', 'TDIGRP') IG v3.3

TSPARMCD = 'TRT' IG v3.2

TSPARMCD = 'TRT' IG v3.3

TSPARMCD = 'TRT' IG v3.2

TSPARMCD = 'TRT' IG v3.3

TSPARMCD = 'PCLAS' IG v3.2

TSPARMCD = 'PCLAS' IG v3.3

TSPARMCD = 'PCLAS' IG v3.2

TSPARMCD = 'PCLAS' IG v3.3

TSPARMCD = 'PCLAS' IG v3.2

TSPARMCD = 'PCLAS' IG v3.3

TSPARMCD = 'FCNTRY' IG v3.2

TSPARMCD = 'FCNTRY' IG v3.3

TSPARMCD = 'ACTSUB' IG v3.2

TSPARMCD = 'ACTSUB' IG v3.3

TSPARMCD in ('INDIC', 'TDIGRP') IG v3.2

TSPARMCD in ('INDIC', 'TDIGRP') IG v3.3

TSVAL not populated with values or synonyms of values in the ISO 21090 null
flavor codelist (or other terms that can be represented as null flavors) IG v3.2

TSVAL not populated with values or synonyms of values in the ISO 21090 null
flavor codelist (or other terms that can be represented as null flavors) IG v3.3
Model v1.4
Model v1.7
Model v1.4
Model v1.7

ECDOSE = null and ECOCCUR ^= 'N' and ECSTAT is null IG v3.2

ECDOSE = null and ECOCCUR ^= 'N' and ECSTAT is null IG v3.3

Custom domain present in study IG v3.2

Custom domain present in study IG v3.3

Custom domain present in study IG v3.2

Custom domain present in study IG v3.3

IDVAR = null Model v1.4

IDVAR = null Model v1.7

--LLOQ present in dataset Model v1.4

--LLOQ present in dataset Model v1.7

IG v3.2

IG v3.3
--TPT present in dataset IG v3.2

--TPT present in dataset IG v3.3

MIDS present in dataset Model v1.7

RELMIDS present in dataset Model v1.7

MIDSDTC present in dataset Model v1.7

IG v3.3

IG v3.3
IG v3.3

Study does not use multi-stage arm assignments and ACTARMCD ^= null IG v3.3

ACTARMCD = null IG v3.3

Study does not use multi-stage arm assignments and ACTARM ^= null IG v3.3

ACTARM = null IG v3.3

Study does not use multi-stage arm assignments and ARMCD ^= null IG v3.3

ARMCD = null IG v3.3

Study does not use multi-stage arm assignments and ACTARM ^= null IG v3.3

ARM = null IG v3.3

ARMCD ^=null and ACTARMCD ^=null IG v3.3

ARMCD = null IG v3.3

ACTARMCD = null IG v3.3

Subject not assigned to treatment IG v3.3

Sponsor collects Other, specify and chooses to map the value to SUPPDM IG v3.3

Subject does not specify race IG v3.3

Mulitple races collected and primary race not specified IG v3.3

IG v3.3

ARM ^= null IG v3.3

ARMNRS ^= null IG v3.3

RACE = MULTIPLE IG v3.3

Milestone associated with RFSTDTC is start of treatment and ARMNRS =null IG v3.3
Model v1.7
Milestone associated with RFSTDTC is start of treatment and ARMNRS ^=null
and ARMNRS ^='UNPLANNED TREATMENT'. IG v3.3

Subject has more than one record per Epoch with DSCAT = 'DISPOSITION
EVENT' IG v3.3

DSCAT = 'DISPOSITION EVENT' and DSSCAT is present in dataset. IG v3.3

DSCAT = 'DISPOSITION EVENT' and DSSCAT is NOT present in dataset. IG v3.3

Subject has more than one record per Epoch with DSCAT = 'DISPOSITION
EVENT' IG v3.3

Subject has more than one record per Epoch with DSCAT = 'DISPOSITION
EVENT' IG v3.3
DM.ACTARMCD not null IG v3.3

IG v3.3

Model v1.7

IG v3.2

IG v3.3

MIDSTYPE = TM.MIDSTYPE and TM.TMRPT = 'N' IG v3.3

MIDSTYPE = TM.MIDSTYPE and TM.TMRPT = 'Y' IG v3.3

IG v3.3
Model v1.7

--ORREF ^= null or --DRVFL='Y' Model v1.7

--STREFC ^= null Model v1.7

Model v1.7
Model v1.7

--LOBXFL = 'Y' and --DRVFL is null Model v1.7

Model v1.7
Parameter is non-normalized. IG v3.3

Parameter is normalized by dose amount. IG v3.3

Parameter is normalized by weight. IG v3.3

Parameter is non-normalized. IG v3.3

Parameter is normalized by dose amount. IG v3.3

Parameter is normalized by weight. IG v3.3
PEORRES = null IG v3.3

REPNUM is in the dataset, and the are multiple records for a subject for a test
within the timeframe identified by the timing variables on the record Model v1.7

Record is derived in a data collection tool. IG v3.3

Model v1.7

--LOBXFL = 'Y' Model v1.7

IG v3.3

VISITNUM present in dataset and --TPTREF not present in dataset IG v3.2

VISITNUM present in dataset and --TPTREF not present in dataset IG v3.3

VISITNUM not present in dataset and --TPTREF present in dataset IG v3.2

VISITNUM not present in dataset and --TPTREF present in dataset IG v3.3

VISITNUM and --TPTREF present in dataset IG v3.2

VISITNUM and --TPTREF present in dataset IG v3.3

Section Item

2.6 3.d

2.6 3.e

2.2.5

4.1.4.4

4.4.4

4.1.4.4

4.4.4

2.2.5 Table 2.2.5: --ELTM

6.2 DS, Assumption 3.c

6.2.3 DS, Assumption 4.c

IG v3.2[3.1]|Model v1.4[2]

2.1

3.2.2

IG v3.2[3.2.2]|Model v1.4[2]

IG v3.3[3.2.2]|Model v1.7[2.1]

IG v3.2[2.5]|Model v1.4[3.2.22]

IG v3.3[2.5]|Model v1.7[3.2.2 2.1]

4.1.1.5

4.1.5

4.1.1.5

4.1.5

4.1.1.5

4.1.5

4.1.1.7 Rule 6
4.1.7 Rule 6

4.1.1.7 Rule 7

4.1.7 Rule 7

Table 3.2.1|3.2.1.1

4.1.2.8.3

4.2.8.3

3.2.2|4.1.2.7.1

3.2.2|4.2.7.1
6.1 Specification

4.2.6 2.E.2
6.1 Specification

4.2.6 2.E.1

2.2.5 Table 2.2.5: --RFTDTC

2.2.5 --RFTDTC
2.2.1 Table 2.2.1: --SCAT
2.2.1 -SCAT

2.2.4 Table 2.2.4: --SEQ

2.2.4 --SEQ

4.1.2.3

4.2.3

4.1.4.5

4.4.5

4.1.4.5

4.4.5

4.1.4.5

4.4.5

5.5

4.1.4.5

4.4.5

IG v3.2[6.2 AE]
[Specification]|Model
v1.4[2.2.2][Table 2.2.2:
IG v3.2[6.2 AE]|Model v1.4[2.2.2] --BDSYCD]
IG v3.3[6.2.1]
[Specification]|Model
v1.7[2.2.2][Table 2.2.2.1:
IG v3.3[6.2.1]|Model v1.7[2.2.2] -BDSYCD]

IG v3.2[6.2 AE]
[Specification]|Model
v1.4[2.2.2][Table 2.2.2:
IG v3.2[6.2 AE]|Model v1.4[2.2.2] --BODSYS]

IG v3.3[6.2.1]
[Specification]|Model
v1.7[2.2.2][Table 2.2.2.1:
IG v3.3[6.2.1]|Model v1.7[2.2.2] --BODSYS]

6.2 Assumption 8

6.2.1 Assumption 9

6.2 Assumption 6a

6.2.1 Assumption 6a

6.2 Assumption 6a
6.2.1 Assumption 6a

6.2 Assumption 6c

6.2.1 Assumption 6c

6.2 Assumption 8

6.2.1 Assumption 9
2.2.5 Timing Variables for All
Classes Specification
2.2.5 Timing Variables for All
Classes Table 2.2.5.1: --ENRTPT
2.2.5 Timing Variables for All
Classes Specification
2.2.5 Timing Variables for All
Classes Table 2.2.5.1: --ENTPT

2.2.2 Table 2.2.2

2.2.2 Table 2.2.2.1

Model v1.4[2.2.2][--
DECOD]|Model
Model v1.4[2.2.2] v1.4[2.2.2][--PTCD]

Model v1.7[2.2.2][--
DECOD]|Model
Model v1.7[2.2.2] v1.7[2.2.2][--PTCD]
2.2.2 --PTCD
2.2.2 --PTCD

2.2.1 (Interventions )|2.2.2 (Events)

Model v1.4[2.2.1 (Interventions )]|

Model v1.4[2.2.2 (Events)]

Model v1.7[2.2.1 (Interventions )]|

Model v1.7[2.2.2 (Events)]
2.2.5 Timing Variables for All
Classes Specification
2.2.5 Timing Variables for All
Classes Table 2.2.5.1: --ENRTPT

2.2.5 Timing Variables for All

Classes Specification

2.2.5 Timing Variables for All

Classes Table 2.2.5.1: --ENTPT
2.2.5 Timing Variables for All
Classes Specification
2.2.5 Timing Variables for All
Classes Table 2.2.5.1: --STRTPT
2.2.5 Timing Variables for All
Classes Specification
2.2.5 Timing Variables for All
Classes Table 2.2.5.1: --STRTPT

2.2.5 Timing Variables for All

Classes Specification

2.2.5 Timing Variables for All

Classes Table 2.2.5.1: --STTPT

2.2.5 Timing Variables for All

Classes Specification

2.2.5 Timing Variables for All

Classes Table 2.2.5.1: --STTPT
6.2 DS Assumption 3.C:
6.2 Assumption 3b
6.2.3 Assumption 3b

6.2 Assumption 3d

6.3 Assumption 2

6.3.15 Assumption 1

5 Specification

5.2 Specification

5 Specification

5.2 Specification

6.2 Assumption 3a

6.2.3 Assumption 3b

6.2 Assumption 3d

6.2
6.2.4

6.2 Assumption 1

6.2.4 Assumption 1

6.2 Assumptions 3.a.i

6.2.6 Assumptions 3.a.1

IG v3.2[2.6]|IG v3.2[4.1.2.6]|IG
v3.2[6.2]

IG v3.3[2.6]|IG v3.3[4.2.6]|IG
v3.3[6.2]
IG v3.2[2.6]|IG v3.2[4.1.2.6]|IG
v3.2[6.2]

IG v3.3[2.6]|IG v3.3[4.2.6]|IG
v3.3[6.2]

Model v1.4[2.2.1 (Interventions )]|

Model v1.4[2.2.2 (Events)]
Model v1.7[2.2.1 (Interventions )]|
Model v1.7[2.2.2 (Events)]
2.2.2
2.2.2
2.2.2
2.2.2
2.2.2
2.2.2
Model v1.4[2.2.1 (Interventions )]|
Model v1.4[2.2.2 (Events)]
Model v1.7[2.2.1 (Interventions )]|
Model v1.7[2.2.2 (Events)]

Model v1.4[2.2.1 (Interventions )]|

Model v1.4[2.2.2 (Events)]

Model v1.7[2.2.1 (Interventions )]|

Model v1.7[2.2.2 (Events)]
Model v1.4[2.2.1 (Interventions )]|
Model v1.4[2.2.2 (Events)]

Model v1.7[2.2.1 (Interventions )]|

Model v1.7[2.2.2 (Events)]

Model v1.4[2.2.1 (Interventions )]|

Model v1.4[2.2.2 (Events)]

Model v1.7[2.2.1 (Interventions )]|

Model v1.7[2.2.2 (Events)]
Model v1.4[2.2.1 (Interventions )]|
Model v1.4[2.2.2 (Events)]

Model v1.7[2.2.1 (Interventions )]|

Model v1.7[2.2.2 (Events)]
2.2.5 Timing Variables for All
Classes Specification
2.2.5 Timing Variables for All
Classes Table 2.2.5.1: --RFTDTC

Model v1.4[2.2.5 Timing Variables Model v1.4[2.2.5 Timing

for All Classes]|IG v3.2[4.1.4.10 Variables for All Classes]
Representing Time Points] [Specification]

Model v1.7[2.2.5 Timing

Model v1.7[2.2.5 Timing Variables Variables for All Classes]
for All Classes]|IG v3.3[4.4.10 [Table 2.2.5.1:
Representing Time Points] --TPTREF]
2.2.5 Timing Variables for All
Classes Specification

2.2.5 Timing Variables for All

Classes Table 2.2.5.1: --TPTREF
The Findings
2.2.3 Observation Class
Table 2.2.1.1, 2.2.2.1,
2.2.1|2.2.3 2.2.3.1: --REASND
2.2.2
2.2.2 Table 3.2.2: --LAT
IG v3.2[6.1][Assumption
2c]|IG v3.2[6.1]
IG v3.2[6.1] [Specification]

IG v3.3[6.1.2]
[Assumption 2c]|IG
IG v3.3[6.1.2] v3.3[6.1.2][Specification]
6.1 Specification
6.1.2 Specification

6.1 Assumption 2a

6.1.2 Assumption 2a

2.2.1

IG v3.2[6.1][Assumption
4a]|IG v3.2[6.1]
IG v3.2[6.1] [Assumption 4b]

Assumption 4a|
6.1.3.2 Assumption 4b
IG v3.2[6.1][Assumption
4a]|IG v3.2[6.1]
IG v3.2[6.1] [Assumption 4b]

IG v3.3[6.1.3.2]
[Assumption 4a]|IG
v3.3[6.1.3.2][Assumption
IG v3.3[6.1.3.2] 4b]

6.1 Assumption 2b

6.1.3.1 Assumption 2b
6.1 Specification
6.1.3.1 Specification

6.1 Specification

6.1.3.1 Specification

6.1 Assumption 6c

6.1.3.1 Assumption 6c

2.2.1

6.1 Assumption 6c
6.1.3.1 Assumption 6c

2.2.1

Specification|Assumption
5 4|Assumption 10
2.2.1 --DOSE Specification
2.2.1 --DOSE Specification

6.1 Specification

2.2.1 Specification

2.2.1 Specification: --DOSTXT

2.2.1 Specification
2.2.1 --DOSU Specification
2.2.1 Specification

2.2.2 --PORTOT Specification

2.2.1 --PORTOT Specification

2.2.2 --DIR Specification

5 Specification
5 Specification

5 Specification
5 Specification
5 Specification

5 Assumption 4

5 Specification

5.2 Specification

5 Specification

5 Assumption 4

5 Specification

5 Assumption 4

5 Specification
2.2.6
Table 2.2.6 DTHFL Description

6.3 Assumption 2

6.3.15 Assumption 1
Specification|DD
5 Assumption 1

IG v3.3[5.2]|IG v3.3[6.3.2]

5 Specification

5.2 Specification

5 Specification

5.2 Specification

5 Specification

5.2 Specification

5|Appendix C2 Assumption 5

5 Assumption 6

IG v3.2[5][Specification:
RFENDTC]|IG v3.2[5]
[Specification: ACTARM]|
IG v3.2[5][Assumption
IG v3.2[5] 10]
IG v3.2[5][Specification:
RFENDTC]|IG v3.2[5]
[Specification: ACTARM]|
IG v3.2[5][Assumption
IG v3.2[5] 10]

Specification|Assumption
5 13

Specification|Assumption
5.2 10c

5 Specification

5.2 Specification

5 Specification

5.2 Specification
2.2.6
Table 2.2.6.1
5 Specification
5.2 Specification
5 Specification
5.2 Specification

5 Specification

5.3 Specification

4.1.2.1

4.2.1

5|7.2 Specification
5.2|7.2 Specification

2.1.1 Specification

2.1.1 Specification
2.1.1 Specification

2.1.1 Specification

5 Specification

5.1 Specification

5 Specification

5.1 Specification

5 Specification

5.1 Specification

5 Specification
5.1 Specification

5 Specification

5.1 Specification

5 Assumption 3

5.1 Assumption 3

6.3 Assumption 2

6.3.15 Assumption 1
6.3 Assumption 2

6.3.15 Assumption 1

6.4.3 Specification

6.3 Assumption 2

6.3.4 Assumption 1

6.3 Assumption 2

6.3.4 Assumption 1
6.3 Specification
6.3.4 Specification

6.3 Assumption 2

6.3.4 Assumption 1

6.3 Assumption 2

6.3.4 Assumption 1

6.3 Specification
6.3.6 Specification

6.3 Specification

6.3.6 Specification

6.3 Specification

6.3.6 Specification

6.3 Specification

6.3.6 Specification

6.3 Specification

6.3.6 Specification

6.3 Specification

6.3.6 Specification
6.3 Specification
6.3.6 Specification
6.3 Specification
6.3.6 Specification

6.3 Specification

6.3.6 Specification

6.3 Specification

6.3.6 Specification
6.3 Specification
6.3.6 Specification

2.6[Item 1, Bullet 5]|

2.6|6.3 6.3[MS Assumption 1]

2.6|6.3.7 2.6[Item 1]|6.3.7[Bullet 5]

6.3 Assumption 3

6.3 Assumption 6
6.3

6.3.12

6.3

6.3.12

8.2

8.2.1 Specification

8.3.1 Example data

8.4

8.4.1
8.4.1

8.4.1

8.4.2

5 SE Assumption 8
5.3 Assumption 6

5 SE Assumption 10

5.3 Assumption 8

5 SE Assumption 11

5.3 Assumption 9

Assumption 10|
5 SE Assumption 11
Assumption 8|
5.3 Assumption 9

5 SE Assumption 6

5.3 Assumption 4

5 SE Assumption 6

5.3 Assumption 4

5 SV Specification

5.5 Description

5 SV Assumption 3
5.5 Assumption 3
5 SV Specification
5.5 Specification

5 SV Specification

5.5 Assumption 4

5 SV Assumption 11

5.5 Assumption 11

5 SV Assumption 11

5.5 Assumption 11

4.1.4

4.4
4.1.4

4.4.4

4.1.4

4.4.4

4.1.4
4.4.4

4.1.4

4.4.4

4.1.4.5

4.4.5

2.2.5

2.2.5 Table 2.2.5.1: --STRF

2.2.5
2.2.5 Table 2.2.5.1: --ENRF

4.1.4.7

4.4.7

4.1.4.7

4.4.7

4.1.4.7

4.4.7
4.1.4.7

4.4.7

4.1.4.8

4.4.8

4.1.4.8

4.4.8
4.1.4.9

4.4.9

4.1.4.10

4.4.10

4.1.4.10
4.4.10

7.2|5|7.3 Specification
5|7.2 Specification
5.2|7.2 Specification
7.2 Specification
7.2 Specification
7.2 Assumption 1
7.2.1 Assumption 1

7.2 Assumption 7

7.2.1 Assumption 7
7.2 Assumption 11
7.2.1 Assumption 12

7.2 Assumption 3

7.2.1 Assumption 3

7.2 Specification

7.2.1 Specification

7.4 Assumption 1

7.4.1 Assumption 1

7.4 Specification

7.4.1 Specification

7.4 Assumption 1
7.4.1 Assumption 1

Specification|Assumption
7.4 3

Specification|Assumption
7.4.1 3

7.4 Specification

7.4.2 Specification
7.4 Specification
7.4.2 Specification
7.4 Specification
7.4.2 Specification

7.4 Specification

7.4.2 Specification

7.4 Specification

7.4.2 Specification

7.4 Specification

7.4.2 Specification
7.4 Specification
7.4.2 Specification
7.4 Specification
7.4.2 Specification
7.4 Specification
7.4.2 Specification
7.4 Assumption 5
7.4.2 Assumption 5

7.4|Appendix C1 Assumption 3

7.4 Assumption 3

7.4|Appendix C1 Assumption 3
7.4 Assumption 3

7.4|Appendix C1 Assumption 3

7.4 Assumption 3

IG v3.2[7.4][Assumption
IG v3.2[7.4]|IG v3.2[Appendix C1] 3]|IG v3.2[Appendix C1]

IG v3.3[7.4.2]
[Assumption 3]|IG
IG v3.3[7.4.2]|IG v3.3[Appendix C1] v3.3[Appendix C1]

IG v3.2[7.4][Assumption
IG v3.2[7.4]|IG v3.2[Appendix C1] 3]|IG v3.2[Appendix C1]

IG v3.3[7.4.2]
[Assumption 3]|IG
IG v3.3[7.4.2]|IG v3.3[Appendix C1] v3.3[Appendix C1]

IG v3.2[7.4][Assumption
IG v3.2[7.4]|IG v3.2[Appendix C1] 3]|IG v3.2[Appendix C1]
IG v3.3[7.4.2]
[Assumption 3]|IG
IG v3.3[7.4.2]|IG v3.3[Appendix C1] v3.3[Appendix C1]

IG v3.2[7.4][Assumption
IG v3.2[7.4]|IG v3.2[Appendix C1] 3]|IG v3.2[Appendix C1]

IG v3.3[7.4.2]
[Assumption 3]|IG
IG v3.3[7.4.2]|IG v3.3[Appendix C1] v3.3[Appendix C1]

IG v3.2[7.4][Assumption
IG v3.2[7.4]|IG v3.2[Appendix C1] 3]|IG v3.2[Appendix C1]

IG v3.3[7.4.2]
[Assumption 3]|IG
IG v3.3[7.4.2]|IG v3.3[Appendix C1] v3.3[Appendix C1]

IG v3.2[7.4][Assumption
IG v3.2[7.4]|IG v3.2[Appendix C1] 3]|IG v3.2[Appendix C1]

IG v3.3[7.4.2]
[Assumption 3]|IG
IG v3.3[7.4.2]|IG v3.3[Appendix C1] v3.3[Appendix C1]

IG v3.2[7.4][Assumption
IG v3.2[7.4]|IG v3.2[Appendix C1] 3]|IG v3.2[Appendix C1]

IG v3.3[7.4.2]
[Assumption 3]|IG
IG v3.3[7.4.2]|IG v3.3[Appendix C1] v3.3[Appendix C1]
IG v3.2[7.4][Assumption
IG v3.2[7.4]|IG v3.2[Appendix C1] 3]|IG v3.2[Appendix C1]

IG v3.3[7.4.2]
[Assumption 3]|IG
IG v3.3[7.4.2]|IG v3.3[Appendix C1] v3.3[Appendix C1]

IG v3.2[7.4][Assumption
IG v3.2[7.4]|IG v3.2[Appendix C1] 3]|IG v3.2[Appendix C1]

IG v3.3[7.4.2]
[Assumption 3]|IG
IG v3.3[7.4.2]|IG v3.3[Appendix C1] v3.3[Appendix C1]

7.4 Assumption 3

7.4 Assumption 3
7.4 Assumption 3

7.4 Assumption 3

7.4 Assumption 3
7.4 Specification
7.4.2 Specification
7.4 Specification
7.4.2 Specification

Section 7.4-TS - Use of Null Flavor

Enumeration

7.4.2.1

7.4 Assumption 3

7.4.2 Assumption 3

7 Specification

7.3.1 Specification

7 Specification
7.3.1 Specification

7 Specification

7.3.1 Specification

7 Specification

7.3.1 Specification

7 Specification

7.3.1 Specification
7 Specification
7.3.1 Specification

6.3 Specification

6.3.16.2 Specification

6.3 Specification

6.3.16.2 Specification

6.3 Specification

6.3.16.2 Specification

6.3 Specification

6.3.16.2 Specification

3.2.2
6.2 Assumption 8

6.2.1 Assumption 9
7.4 Specification
7.4.2 Specification

2.2

2.2
2.2
2.2

2.2

4.2.8.3

2.2

4.2.1

2.5

2.6

2.2.4

2.5

IG v3.3[2.5]|Model v1.7[2.1]

IG v3.2[2.6]|IG v3.2[6.3]
IG v3.2[2.6]|IG v3.2[6.3] [PP]

IG v3.3[2.6]|IG
IG v3.3[2.6]|IG v3.3[6.3.11.2] v3.3[6.3.11.2]
2.6

2.6 3.b

2.6

7.2 Assumption 8 for TE

7.2.2 Assumption 8

7.2 Assumption 9 for TE

7.2.2 Assumption 9

7.2 Assumption 13 for TE

7.2.2 Assumption 13

Specification|Assumption
7.2 15

7.2.2 Assumption 15

Specification|Assumption
7.2 12

Specification|Assumption
7.2.2 12

Specification|Assumption
7.2 12

Specification|Assumption
7.2.2 12

4.1.1.4

4.1.4
4.1.1.7 6

4.1.7 6

4.1.1.7 6

4.1.7 6

4.1.1.7 7

4.1.7 7

4.1.2.6

4.2.6

4.1.2.6

4.2.6

4.1.2.6

4.2.6
4.1.2.6

4.2.6

4.1.2.6

4.2.6

4.1.2.7.3

4.2.7.3

4.1.2.7.3

4.2.7.3

4.1.2.7.3

4.2.7.3

4.1.2.8.1

4.2.8.1

4.1.2.8.1
4.2.8.1

4.1.2.8.1

4.2.8.1

4.1.2.8.2

4.2.8.2

4.1.5.1.1

4.5.1.1

4.1.2.2
4.2.2

4.1.2.6

4.2.6
3.2.2
3.2.2

2.7

2.7
2.7

2.7

2.6 3h

2.6 3h
4.1.4
Table 4.1.4.1

Table 4.1.4.1
4.1.4

Table 4.1.4.1

4.1.4

Table 4.1.4.1

5.1.1

6.1

5.1.1

6.1

5.1.1

6.1.1

2.2.6

2.2.7

IG v3.2[4.1.2.1]|Model v1.4[3.3.1]
IG v3.3[7.4.1 ]|Model v1.7[3.2.1]

8.4.2

8.4.2
4.1.1 RDOMAIN Description
4.1.1.1 RDOMAIN Description

IG v3.2[7.3]|Model v1.4[3.5.1]

IG v3.3[7.3.2]|Model v1.7[3.4.1]

IG v3.2[7.3]|Model v1.4[3.5.1]
IG v3.3[7.3]|Model v1.7[3.4.1]
2.2.2
2.2.2
2.2.2
2.2.2

2.2.1

2.2.2
2.2.2
2.2.2
2.2.2
2.2.2
2.2.2
2.2.2
2.2.2
2.2.2
2.2.2
2.2.2

2.2.2

2.2.2
2.2.2
2.2.2

2.2.2

2.2.2
2.2.2
2.2.2
2.2.2
2.2.2
2.2.2

2.2.2

2.2.2.1 --CONTRT

IG v3.2[6.3 LB]|Model v1.4[2.2.3]

IG v3.3[6.3.6]|Model v1.7[2.2.3]

6.2 DS Assumption 5.a

2.2.3

2.2.3
Model v1.4[2.2.1 (Interventions )]|
Model v1.4[2.2.2 (Events)]

Model v1.7[2.2.1 (Interventions )]|

Model v1.7[2.2.2 (Events)]

4.1.5.3.1

4.5.3.1

6.1

6.1.3 Assumption 1.c

3.2

4.1.2.6 2.B.1
4.2.6 2.B.1
5 SV

IG v3.3[5.5 SV]|IG
v3.3[7.3.1.1 TV][TV
IG v3.3[5.5 SV]|IG v3.3[7.3.1.1 TV] Issues 4]
8.4.1

8.4

6.2 DS Assumption 1

2.1

5 SE Assumption 2

5 SE Assumptions
7.2
7.2.1

4.1.2

4.1.2
4.1.2

4.1.2

2.2.5

IG v3.2[8.2.1]|IG v3.2[8.3.1]

IG v3.3[8.2.1]|IG v3.3[8.3.1]

2.2.5

2.2.5
6.3 LB
6.3.6 LB

2.2.1
2.2.1
2.2.3

2.2.3
2.2.3

2.2.3

2.2.2|2.2.3

2.2.2|2.2.3
2.2.1|2.2.2|2.2.3
2.2.1[Table 3.2.1:
--SCAT]|2.2.2[Table
3.2.2: --SCAT]|
2.2.3[Table 3.2.3:
2.2.1|2.2.2|2.2.3 --SCAT]
2.2.1|2.2.2|2.2.3
2.2.1[Table 3.2.1:
--SCAT]|2.2.2[Table
3.2.2: --SCAT]|
2.2.3[Table 3.2.3:
2.2.1|2.2.2|2.2.3 --SCAT]

4.1.1.5

4.1.5
2.2.6
Table 2.2.6.1
2.2.6
Table 2.2.6.1
2.2.6
Table 2.2.6.1
2.2.6

Table 2.2.6.1
2.2.2
2.2.2
2.2.2
2.2.2

7.4|Appendix C1 Assumption 3

7.4 Assumption 3

7.4|Appendix C1 Assumption 3

7.4 Assumption 3

7.4|Appendix C1 Assumption 3

7.4 Assumption 3

7.4|Appendix C1 Assumption 3

7.4 Assumption 3

7.4|Appendix C1 Assumption 3

7.4 Assumption 3

7.4|Appendix C1 Assumption 3

7.4 Assumption 3

7.4|Appendix C1 Assumption 3

7.4 Assumption 3
7.4|Appendix C1 Assumption 3

7.4 Assumption 3

7.4|Appendix C1 Assumption 3

7.4 Assumption 3

7.4|Appendix C1 Assumption 3

7.4 Assumption 3

7.4|Appendix C1 Assumption 3

7.4 Assumption 3

7.4|Appendix C1 Assumption 3

7.4 Assumption 3

7.4|Appendix C1 Assumption 3

7.4 Assumption 3

7.4|Appendix C1 Assumption 3

7.4 Assumption 3

7.4|Appendix C1 Assumption 3

7.4 Assumption 3

7.4|Appendix C1 Assumption 3
7.4 Assumption 3

7.4|Appendix C1 Assumption 3

7.4 Assumption 3

7.4|Appendix C1 Assumption 3

7.4 Assumption 3

7.4|Appendix C1 Assumption 3

7.4 Assumption 3

Section 7.4-TS: Use of Null Flavor

Enumeration

7.4.2.1
2.2.2
2.2.2
2.2.2
2.2.2

Assumption 4a|
6.1 Assumption 4b
Assumption 4a|
6.1.3 Assumption 4b

2.6

2.6 3.b

2.2.7

2.2.7|5.1.2

2.2.3

2.2.3
IG v3.2[4.1.1.3]|IG v3.2[4.1.1.8]

IG v3.3[4.1.3]|IG v3.3[4.4.8]
4.1.4.10

4.4.10

2.2.5 --MIDS

2.2.5 --RELMIDS
2.2.5 --MIDSDTC

2.7

2.7
2.7

5.2 Specification

Specification|Assumption
5.2 4

5.2 Assumption 4

5.2 Assumption 4
5.2 Assumption 6

5.2 Assumption 6

5.2 Assumption 5

5.2 Specification

5.2 Assumption 6

Specification|Assumption
5.2 9
Table 2.2.6.1 RPATHCD
Specification|Assumption
5.2 4.a.4|Assumption 9

6.2.3 DS Assumption 2.b

Assumption 2.b|
6.2.3 DS Assumption 5

6.2.3 DS Assumption 2.b.1

Assumption 2.b.2|
6.2.3 DS Assumption 2.b.3
6.2.3 DS Assumption 1

Various Findings Domains CDISC Notes

Table 2.2.12.1 EGBEATNO

5 SE Specification

5.4 5.5|6.1.5 Specification

5.5 Assumption 2.a

5.5 Assumption 2.b

5.5 Assumption 3.a

Table 2.2.3 --ORREF

Table 2.2.3 --STREFC

Table 2.2.3 --STREFN

Table 2.2.3 --RESLOC

Table 2.2.3 --LOBXFL

2.2.4
6.3.11.2 Assumption 3

6.3.11.2 Assumption 3

6.3.11.2 Assumption 3
6.3.11.2 Assumption 3
6.3.12 PESTRESC

Table 2.2.3 --REPNUM

6.3.13.3 Assumption 4

Table 2.2.12.1 MSAGENT

Table 2.2.12.1 MSCONC

Table 2.2.12.1 MSCONCU

Table 2.2.12.1 MHEVDTYP

Table 2.2.12.1 EXMETHOD

Table 2.2.3 --LOXBFL

7.2|5.2|7.3 Specification

4.1.4.10
4.4.10

4.1.4.10

4.4.10

4.1.4.10

4.4.10
Cited Guidance

Check the CDISC Controlled Terminology [see Appendix C - Controlled

Terminology] for reserved two-character domain identifiers or abbreviations. If
one has not been assigned by CDISC, then the sponsor may select the unique
two-character domain code to be used consistently throughout the submission.

Determine the domain code, one that is not a domain code in the CDISC
Controlled Terminology codelist "SDTM Domain Abbreviations" available at
http://www.cancer.gov/research/resources/terminology/cdisc. If it desired to
have this domain code as part of CDISC controlled terminology, then submit a
request to https://ncitermform.nci.nih.gov/ncitermform/?version=cdisc. The
sponsor-selected, two-character domain code should be used consistently
throughout the submission.
Collected duration of an event, intervention, or finding represented in ISO 8601
character format. Used only if collected on the CRF and not derived.
Collected duration of an event, intervention, or finding. Used only if collected on
the CRF and not derived. Format=ISO8601

IG v3.2[4.1.4.4][The Study Day value is incremented by 1 for each date

IG v3.3[4.4.4][The Study Day value is incremented by 1 for each date following

RFSTDTC. Dates prior to RFSTDTC are decreased by 1, with the date
preceding RFSTDTC designated as Study Day -1 (there is no Study Day
0). . . . All Study Day values are integers.] IG v3.3[4.4.4][ Thus, to calculate
Study Day: --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if
--DTC is on or after RFSTDTC --DY = (date portion of --DTC) - (date portion of
RFSTDTC) if --DTC precedes RFSTDTC This algorithm should be used across
all domains.]
The permissible Study Day variables (--DY, --STDY, and --ENDY) . . . are
determined by comparing the date portion of the respective date/time variables
(--DTC, --STDTC, and --ENDTC) to the date portion of the Subject Reference
Start Date (RFSTDTC from the Demographics domain).
The permissible Study Day variables (--DY, --STDY, and --ENDY) . . . are
determined by comparing the date portion of the respective date/time variables
(--DTC, --STDTC, and --ENDTC) to the date portion of the Subject Reference
Start Date (RFSTDTC from the Demographics domain).
Planned Elapsed time in ISO 8601 character format relative to a planned fixed
reference (--TPTREF) such as "Previous Dose" or "Previous Meal".
Planned Elapsed time relative to a planned fixed reference (--TPTREF) such as
"Previous Dose" or "Previous Meal". This variable is useful where there are
repetitive measures. Not a clock time or a date/time variable, but an interval.
Format=ISO8601
... EPOCH, as a Timing variable, is the name of the Epoch during which
--STDTC or --DTC falls. The values of EPOCH are drawn from the Trial Arms
domain, Section 7.2 - Experimental Design: Trial Arms (TA)
EPOCH may be included as a timing variable as in other general-observation-
class domains. In DS, EPOCH is based on DSSTDTC. The values of EPOCH
are drawn from the Trial Arms (TA) dataset (Section 7.2.1, Trial Arms).
IG v3.2[3.1][Since these roles are predefined for all standard domains that
follow the general observation classes]|Model v1.4[2][Each variable . . . can be
classified according to its Role]
Each variable can be classified according to its Role. A Role determines the
type of information conveyed by the variable about each distinct observation
and how it can be used. Variables can be classified into five major roles
Following SDTM-specified controlled terminology and format guidelines for
variables, when provided
Following SDTM-specified controlled terminology and format guidelines for
variables, when provided

IG v3.2[3.2.2][Using SDTM-specified data types for all variables]|Model v1.4[2]

[The data Type (e.g., whether the variable value is a character or numeric)]
IG v3.3[3.2.2][Using SDTM-specified data types for all variables]|Model
v1.7[2.1][The SDTM describes the name, label, role, and type for the standard
variables. Note that the SDTM type specified in this document is either
character or numeric, as these are the only types supported by SAS v.5
transport files.]
IG v3.2[2.5][Sponsors may not add any other variables. . . . Standard variables
must not be renamed or modified for novel usage. Using SDTM-specified
standard variable names.]|Model v1.4[3.2.22][Each observation can be
described by a series of named variables.]

IG v3.3[2.5][Sponsors may not add any other variables. . . . Standard variables

must not be renamed or modified for novel usage]|IG v3.3[2.5][[Using SDTM-
specified standard variable names]|Model v1.7[3.2.2 2.1][Each observation can
be described by a series of named variables. Domain-specific variables, a
concept introduced in SDTM v1.5, are for use in a limited number of
designated domains and will be identified in the appropriate implementation
guide.]
Required variables must always be included in the dataset and cannot be null
for any record.
Required variables must always be included in the dataset and cannot be null
for any record.
The sponsor does not have the discretion to exclude permissible variables
when they contain data.
The sponsor does not have the discretion to exclude permissible variables
when they contain data.
When no data has been collected for an expected variable, however, a null
column must still be included in the dataset, and a comment must be included
in the define.xml to state that data was not collected.
When no data has been collected for an expected variable, however, a null
column must still be included in the dataset, and a comment must be included
in the define.xml to state that data was not collected.
Split dataset names can be up to four characters in length. For example, if
splitting by --CAT, then dataset names would be the domain name plus up to
two additional characters (e.g., QS36 for SF-36). If splitting Findings About by
parent domain, then the dataset name would be the domain name plus the
two-character domain code describing the parent domain code (e.g., FACM).
Split dataset names can be up to four characters in length. For example, if
splitting by --CAT, then dataset names would be the domain name plus up to
two additional characters (e.g., QS36 for SF-36). If splitting Findings About by
parent domain, then the dataset name would be the domain name plus the
two-character domain code describing the parent domain code (e.g., FACM).
Supplemental Qualifier datasets for split domains would also be split. The
nomenclature would include the additional one-to-two characters used to
identify the split dataset.
Supplemental Qualifier datasets for split domains would also be split. The
nomenclature would include the additional one-to-two characters used to
identify the split dataset.
Table 3.2.1[Note that the key variables shown in this table are examples only.
A sponsor's actual key structure may be different.]|3.2.1.1[Since the purpose of
this column is to aid reviewers in understanding the structure of a dataset,
sponsors should list all of the natural keys (see definition below) for the
dataset. These keys should define uniqueness for records within a dataset, and
may define a record sort order.]
Table 3.2.1[Note that the key variables shown in this table are examples only.
A sponsor's actual key structure may be different.]||3.2.1.1[Since the purpose
of this column is to aid reviewers in understanding the structure of a dataset,
sponsors should list all of the natural keys (see definition below) for the
dataset. These keys should define uniqueness for records within a dataset, and
may define a record sort order.]

[Conformance with the SDTMIG Domain Models is minimally indicated by

following SDTM-specified controlled terminology and format guidelines for
variables, when provided][The SDTM permits one value for each Qualifier
variable per record. If multiple values exist (e.g., due to a "Check all that apply"
instruction on a CRF), then the value for the Qualifier variable should be
"MULTIPLE" and SUPP-- should be used to store the individual responses.]
3.2.2[Conformance with the SDTMIG Domain Models is minimally indicated by
following SDTM-specified controlled terminology and format guidelines for
variables, when provided]|4.1.2.7.1[When the CRF includes a list of values for
a qualifier field that includes "Other" and the "Other" is supplemented with a
"Specify" free text field,]
3.2.2[Conformance with the SDTMIG Domain Models is minimally indicated by
following SDTM-specified controlled terminology and format guidelines for
variables, when provided]|4.2.7.1[When the CRF includes a list of values for a
qualifier field that includes "Other" and the "Other" is supplemented with a
"Specify" free text field,]
Identifier used to link related, grouped records across domains.
--LNKGRP is a grouping identifier used to identify a group of records in one
domain that is related to a record in another domain, often forming a many-to-
one relationship.
Identifier used to link related records across domains.

--LNKID is a grouping identifier used to identify a record in one domain that is

related to records in another domain, often forming a one-to-many relationship.
Date/time for a fixed reference time point defined by --TPTREF in ISO 8601
character format.
Date/time for a fixed reference time point defined by --TPTREF
Used to define a further categorization of --CAT values.
Used to define a further categorization of --CAT values.
Sequence number to ensure uniqueness of records within a dataset for a
subject (or within a parameter, in the case of the Trial Summary domain). May
be any valid number (including decimals) and does not have to start at 1.
Sequence number to ensure uniqueness of records within a dataset for a
subject (or within a parameter, in the case of the Trial Summary domain). May
be any valid number (including decimals) and does not have to start at 1.
... a unique identifier (USUBJID) should be assigned and included in all
datasets. The unique subject identifier (USUBJID) is required in all datasets
containing subject-level data.
The unique subject identifier (USUBJID) is required in all datasets containing
subject-level data. USUBJID values must be unique for each trial participant
(subject) across all trials in the submission.
For planned visits, values of VISIT, VISITNUM, and VISITDY must be those
defined in the Trial Visits dataset,
For planned visits, values of VISIT, VISITNUM, and VISITDY must be those
defined in the Trial Visits dataset,
For planned visits, values of VISIT, VISITNUM, and VISITDY must be those
defined in the Trial Visits dataset,
For planned visits, values of VISIT, VISITNUM, and VISITDY must be those
defined in the Trial Visits dataset,
For planned visits, values of VISIT, VISITNUM, and VISITDY must be those
defined in the Trial Visits dataset,
For planned visits, values of VISIT, VISITNUM, and VISITDY must be those
defined in the Trial Visits dataset,
The Subject Visits domain consolidates information about the timing of subject
visits that is otherwise spread over domains that include the visit variables
(VISITNUM and possibly VISIT and/or VISITDY).
The Subject Visits domain consolidates information about the timing of subject
visits that is otherwise spread over domains that include the visit variables
(VISITNUM and possibly VISIT and/or VISITDY).
There should be a one-to-one relationship between values of VISIT and
VISITNUM.
There should be a one-to-one relationship between values of VISIT and
VISITNUM.

IG v3.2[6.2 AE][Specification][IG: Dictionary derived. Code for body system or

organ class used by the sponsor from the coding dictionary (e.g., MedDRA).
When using a multi-axial dictionary such as MedDRA, this should contain the
SOC used for the sponsor's analyses and summary tables which may not
necessarily be the primary SOC.]|Model v1.4[2.2.2][Table 2.2.2: --BDSYCD]
[Model:MedDRA System Organ Class code corresponding to --BODSYS
assigned for analysis.]
IG v3.3[6.2.1][Specification][Dictionary derived. Code for body system or organ
class used by the sponsor from the coding dictionary (e.g., MedDRA). When
using a multi-axial dictionary such as MedDRA, this should contain the SOC
used for the sponsor's analyses and summary tables which may not
necessarily be the primary SOC.]|Model v1.7[2.2.2][Table 2.2.2.1: -BDSYCD]
[Model:MedDRA System Organ Class code corresponding to --BODSYS
assigned for analysis.]

IG v3.2[6.2 AE][Specification][Dictionary derived. Body system or organ class

IG v3.3[6.2.1][Specification][Dictionary derived. Body system or organ class

used by the sponsor from the coding dictionary (e.g., MedDRA). When using a
multi-axial dictionary such as MedDRA, this should contain the SOC used for
the sponsor's analyses and summary tables which may not necessarily be the
primary SOC.]|Model v1.7[2.2.2][Table 2.2.2.1: --BODSYS][Model: Body
system or system organ class assigned for analysis from a standard hierarchy
(e.g. MedDRA) associated with an event.]
The following Qualifiers would not be used in AE: --OCCUR, --STAT, and--
REASND. They are the only Qualifiers from the SDTM Events Class not in the
AE domain. They are not permitted because the AE domain contains only
records for adverse events that actually occurred.
The following Qualifiers would not be used in AE: --OCCUR, --STAT, and--
REASND. They are the only Qualifiers from the SDTM Events Class not in the
AE domain. They are not permitted because the AE domain contains only
records for adverse events that actually occurred.
If categories of serious events are collected secondarily to a leading question,
as in the example below, the values of the variables that capture reasons an
event is considered serious (i.e., AESCAN, AESCONG, etc.) may be null. For
example, if Serious is answered "No, " the values for these variables may be
null. However, if Serious is answered "Yes, " at least one of them will have a
"Y" response.
If categories of serious events are collected secondarily to a leading question,
as in the example below, the values of the variables that capture reasons an
event is considered serious (i.e., AESCAN, AESCONG, etc.) may be null. For
example, if Serious is answered "No, " the values for these variables may be
null. However, if Serious is answered "Yes, " at least one of them will have a
"Y" response.
If categories of serious events are collected secondarily to a leading question,
as in the example below, the values of the variables that capture reasons an
event is considered serious (i.e., AESCAN, AESCONG, etc.) may be null. For
example, if Serious is answered "No, " the values for these variables may be
null. However, if Serious is answered "Yes, " at least one of them will have a
"Y" response.
If categories of serious events are collected secondarily to a leading question,
as in the example below, the values of the variables that capture reasons an
event is considered serious (i.e., AESCAN, AESCONG, etc.) may be null. For
example, if Serious is answered "No, " the values for these variables may be
null. However, if Serious is answered "Yes, " at least one of them will have a
"Y" response.
When a description of Other Medically Important Serious Adverse Events
category is collected on a CRF, sponsors should place the description in the
SUPPAE dataset using the standard supplemental qualifier name code
AESOSP.
When a description of Other Medically Important Serious Adverse Events
category is collected on a CRF, sponsors should place the description in the
SUPPAE dataset using the standard supplemental qualifier name code
AESOSP.
The following Qualifiers would not be used in AE: --OCCUR, --STAT, and--
REASND. They are the only Qualifiers from the SDTM Events Class not in the
AE domain. They are not permitted because the AE domain contains only
records for adverse events that actually occurred.
The following Qualifiers would not be used in AE: --OCCUR, --STAT, and--
REASND. They are the only Qualifiers from the SDTM Events Class not in the
AE domain. They are not permitted because the AE domain contains only
records for adverse events that actually occurred.
(--ENRTPT) Identifies the end of the observation as being before or after the
sponsor-defined reference time point defined by variable --ENTPT.
Identifies the end of the observation as being before or after the sponsor-
defined reference time point defined by variable --ENTPT.
(--ENRTPT) Identifies the end of the observation as being before or after the
sponsor-defined reference time point defined by variable --ENTPT.
Identifies the end of the observation as being before or after the sponsor-
defined reference time point defined by variable --ENTPT.
If the value for --TERM is modified for coding purposes, then the modified text
is placed here.
If the value for --TERM is modified for coding purposes, then the modified text
is placed here.
Model v1.4[2.2.2][--DECOD][Dictionary or sponsor-defined derived text
description of the topic variable, --TERM, or the modified topic variable (--
MODIFY), if applicable. Equivalent to the Preferred Term (PT in MedDRA).]|
Model v1.4[2.2.2][--PTCD][MedDRA Preferred Term code.]
Model v1.7[2.2.2][--DECOD][Dictionary or sponsor-defined derived text
description of the topic variable, --TERM, or the modified topic variable (--
MODIFY), if applicable. Equivalent to the Preferred Term (PT in MedDRA).]|
Model v1.7[2.2.2][--PTCD][MedDRA Preferred Term code.]
MedDRA Preferred Term code.
MedDRA Preferred Term code.
(--PRESP/Events) Used to indicate whether the event describe by --TERM was
pre-specified on a CRF. Value is Y for pre-specified events, null for
spontaneously reported events. (--PRESP/Interventions) Used when a specific
intervention is pre-specified on a CRF. Values should be "Y" or null. (--
REASND) Used in conjunction with --STAT when value is NOT DONE
(--PRESP/Events) Used to indicate whether the event describe by --TERM was
pre-specified on a CRF. Value is Y for pre-specified events, null for
spontaneously reported events. (--PRESP/Interventions) Used when a specific
intervention is pre-specified on a CRF. Values should be "Y" or null. (--
REASND) Used in conjunction with --STAT when value is NOT DONE

Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a specific intervention

is pre-specified on a CRF. Values should be "Y" or null.]|Model v1.4[2.2.2
(Events)][--PRESP Used to indicate whether the event describe by --TERM
was pre-specified on a CRF. Value is Y for pre-specified events, null for
spontaneously reported events. --STAT Used to indicate when a question
about the occurrence of a pre-specified event was not answered. Should be
null or hav a value of NOT DONE]

Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a specific intervention

is pre-specified on a CRF. Values should be "Y" or null.]|Model v1.7[2.2.2
(Events)][--PRESP Used to indicate whether the event describe by --TERM
was pre-specified on a CRF. Value is Y for pre-specified events, null for
spontaneously reported events. --STAT Used to indicate when a question
about the occurrence of a pre-specified event was not answered. Should be
null or hav a value of NOT DONE]
(--ENRTPT) Identifies the end of the observation as being before or after the
sponsor-defined reference time point defined by variable --ENTPT.
Identifies the end of the observation as being before or after the sponsor-
defined reference time point defined by variable --ENTPT.
(--ENTPT) Description or date/time in ISO 8601 or other character format of the
sponsor-defined reference point referred to by --ENRTPT. Examples: "2003-
12-25" or "VISIT 2".
Description or date/time in ISO 8601 or other character format of the sponsor-
defined reference point referred to by --ENRTPT. Examples: "2003-12-25" or
"VISIT 2".
(--STRTPT) Identifies the start of the observation as being before or after the
sponsor-defined reference time point defined by variable --STTPT.
Identifies the start of the observation as being before or after the sponsor-
defined reference time point defined by variable --STTPT.
(--STRTPT) Identifies the start of the observation as being before or after the
sponsor-defined reference time point defined by variable --STTPT.
Identifies the start of the observation as being before or after the sponsor-
defined reference time point defined by variable --STTPT.
(--STTPT) Description or date/time in ISO 8601 or other character format of the
sponsor-defined reference point referred to by --STRTPT. Examples: "2003-12-
15" or "VISIT 1".
Description or date/time in ISO 8601 or other character format of the sponsor-
defined reference point referred to by --STRTPT. Examples: "2003-12-15" or
"VISIT 1".
(--STTPT) Description or date/time in ISO 8601 or other character format of the
sponsor-defined reference point referred to by --STRTPT. Examples: "2003-12-
15" or "VISIT 1".
Description or date/time in ISO 8601 or other character format of the sponsor-
defined reference point referred to by --STRTPT. Examples: "2003-12-15" or
"VISIT 1".
A sponsor may collect one disposition event for the trial as a whole, or they
may collect disposition for each Epoch of the trial. When disposition is collected
for each Epoch, the variable EPOCH should be included in the DS dataset.
When EPOCH is populated for disposition events (records with DSCAT =
DISPOSITION EVENT), EPOCH is the name of the Epoch for the disposition
event described in the record. This is a subtly different meaning from that of
EPOCH when it is used in other general-observation-class domains, where
EPOCH, as a Timing variable, is the name of the Epoch during which --STDTC
or --DTC falls. The values of EPOCH are drawn from the Trial Arms domain,
Section 7.2 - Experimental Design: Trial Arms (TA)
b. When DSTERM = 'COMPLETED', DSDECOD = 'COMPLETED'.
b. When DSTERM = 'COMPLETED', DSDECOD = 'COMPLETED'.

d. When DSCAT='PROTOCOL MILESTONE', DSTERM and DSDECOD will

contain the same value drawn from the sponsor's controlled terminology.
For example, if a subject's Survival Status is "DEAD", the date of death must
be stored in DM and within a final disposition record in DS.
For example, if a subject's Survival Status is "DEAD", the date of death must
be stored in DM and within a final disposition record in DS.
Date/time of informed consent in ISO 8601 character format. This will be the
same as the date of informed consent in the Disposition domain, if that protocol
milestone is documented.
Date/time of informed consent in ISO 8601 character format. This will be the
same as the date of informed consent in the Disposition domain, if that protocol
milestone is documented.
Date/time of death for any subject who died, in ISO 8601 format. Should
represent the date/time that is captured in the clinical-trial database.
Date/time of death for any subject who died, in ISO 8601 format. Should
represent the date/time that is captured in the clinical-trial database.
When DSCAT='DISPOSITION EVENT", DSTERM contains either
"COMPLETED" or, if the subject did not complete, specific verbatim information
about the disposition event
When DSCAT = "DISPOSITION EVENT" DSTERM contains either
"COMPLETED" or, if the subject did not complete, specific verbatim information
about the reason for non-completion
When DSCAT='PROTOCOL MILESTONE', DSTERM and DSDECOD will
contain the same value drawn from the sponsor's controlled terminology.
Examples of controlled terms include 'INFORMED CONSENT OBTAINED' and
'RANDOMIZED.' EPOCH should not be populated when DSCAT =
"PROTOCOL MILESTONE".

The intent of the domain is to capture protocol violations and deviations during
the course of the study and will store only those criteria violation by or deviated
from by the subject and not a response to each violation or deviation.
The intent of the domain model is to capture protocol deviations that occurred
during the course of the study (see ICH E3: Section 10.2 at
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficac
y/E3/E3_Guideline.pdf). Usually these are deviations that occur after the
subject has been randomized or received the first treatment.
The DV domain is an Events model for collected protocol deviations and not for
derived protocol deviations that are more likely to be part of analysis
The DV domain is an Events model for collected protocol deviations and not for
derived protocol deviations that are more likely to be part of analysis.
This categorization should not group all records (within the MH Domain) into
one generic group such as "Medical History" or "General Medical History"
because this is redundant information with the domain code. If no smaller
categorization can be applied, then it is not necessary to include or populate
this variable.
This categorization should not group all records (within the MH Domain) into
one generic group such as "Medical History" or "General Medical History"
because this is redundant information with the domain code. If no smaller
categorization can be applied, then it is not necessary to include or populate
this variable.

IG v3.2[2.6][Section 2.6: Do not create separate domains based on time, rather

represent both prior and current observations in a domain (e.g., CM for all non-
study medications). Note that AE and MH are an exception to this best practice
because of regulatory reporting needs.]|IG v3.2[4.1.2.6][Section 4.1.2.6, Item
2.B.3.A (Discussion of --CAT/--SCAT): Adverse Events (AE), Medical History
(MH) and Clinical Events (CE), for example, are conceptually the same data,
the only differences being when the event started relative to the study start and
whether the event is considered a regulatory reportable adverse event in the
study.]|IG v3.2[6.2][Domain Code Table: The medical history dataset includes
the subject's prior history at the start of the trial.][MH: The medical history
dataset includes the subject's prior history at the start of the trial.][Assumption
1:The Medical History dataset generally includes the subject's prior and
concomitant conditions at the start of the trial.]

IG v3.3[2.6][Do not create separate domains based on time; rather, represent

both prior and current observations in a domain (e.g., CM for all non-study
medications). Note that AE and MH are an exception to this best practice
because of regulatory reporting needs]|IG v3.3[4.2.6][Item 2.B.3.A (Discussion
of --CAT/--SCAT): Adverse Events (AE), Medical History (MH), and Clinical
Events (CE), for example, are conceptually the same data, the only differences
being when the event started relative to the study start and whether the event
is considered a regulatory reportable adverse event in the study.]|IG v3.3[6.2]
[Domain Code Table: The medical history dataset includes the subject's prior
history at the start of the trial.][MH: The medical history dataset includes the
subject's prior history at the start of the trial.][Assumption 1:The Medical History
dataset generally includes the subject's prior and concomitant conditions at the
start of the trial.]
IG v3.2[2.6][Section 2.6: Do not create separate domains based on time, rather
represent both prior and current observations in a domain (e.g., CM for all non-
study medications). Note that AE and MH are an exception to this best practice
because of regulatory reporting needs.]|IG v3.2[4.1.2.6][Section 4.1.2.6, Item
2.B.3.A (Discussion of --CAT/--SCAT): Adverse Events (AE), Medical History
(MH) and Clinical Events (CE), for example, are conceptually the same data,
the only differences being when the event started relative to the study start and
whether the event is considered a regulatory reportable adverse event in the
study.]|IG v3.2[6.2][Domain Code Table: The medical history dataset includes
the subject's prior history at the start of the trial.][MH: The medical history
dataset includes the subject's prior history at the start of the trial.][Assumption
1:The Medical History dataset generally includes the subject's prior and
concomitant conditions at the start of the trial.]

IG v3.3[2.6][Do not create separate domains based on time; rather, represent

Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention

is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to
record whether a pre-specified event occurred when information about the
occurrence of a specific event is solicited.][--STAT: Used to indicate when a
question about the occurrence of a pre-specified event was not answered.
Should be null or hav a value of NOT DONE][--REASND: Used in conjunction
with --STAT when value is NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP:
Used to indicate whether the event describe by --TERM was pre-specified on a
CRF. Value is Y for pre-specified events, null for spontaneously reported
events.][--OCCUR: Used to record whether a pre-specified event occurred
when information about the occurrence of a specific event is solicited.][--STAT:
Used to indicate when a question about the occurrence of a pre-specified event
was not answered . Should be null or hav a value of NOT DONE][--REASND:
Used in conjunction with --STAT when value is NOT DONE]
Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention
is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to
record whether a pre-specified event occurred when information about the
occurrence of a specific event is solicited.][--STAT: Used to indicate when a
question about the occurrence of a pre-specified event was not answered.
Should be null or hav a value of NOT DONE][--REASND: Used in conjunction
with --STAT when value is NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP:
Used to indicate whether the event describe by --TERM was pre-specified on a
CRF. Value is Y for pre-specified events, null for spontaneously reported
events.][--OCCUR: Used to record whether a pre-specified event occurred
when information about the occurrence of a specific event is solicited.][--STAT:
Used to indicate when a question about the occurrence of a pre-specified event
was not answered . Should be null or hav a value of NOT DONE][--REASND:
Used in conjunction with --STAT when value is NOT DONE]
Variable Qualifier of --BODSYS
Variable Qualifier of --BODSYS
Variable Qualifier of --BODSYS
Variable Qualifier of --BODSYS
Variable Qualifier of --TOXGR
Variable Qualifier of --TOXGR
Model v1.4[2.2.1 (Interventions )][--PRESP: Values should be "Y" or null.]|
Model v1.4[2.2.2 (Events)][--PRESP: Values should be "Y" or null.]
Model v1.7[2.2.1 (Interventions )][--PRESP: Values should be "Y" or null.]|
Model v1.7[2.2.2 (Events)][--PRESP: Values should be "Y" or null.]

Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention

Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention

is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to
record whether a pre-specified event occurred when information about the
occurrence of a specific event is solicited.][--STAT: Used to indicate when a
question about the occurrence of a pre-specified event was not answered.
Should be null or hav a value of NOT DONE]|Model v1.7[2.2.2 (Events)][--
PRESP: Used to indicate whether the event describe by --TERM was pre-
specified on a CRF. Value is Y for pre-specified events, null for spontaneously
reported events.][--OCCUR: Used to record whether a pre-specified event
occurred when information about the occurrence of a specific event is
solicited.][--STAT: Used to indicate when a question about the occurrence of a
pre-specified event was not answered . Should be null or have a value of NOT
DONE]
Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention
is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to
record whether a pre-specified event occurred when information about the
occurrence of a specific event is solicited.][--STAT: Used to indicate when a
question about the occurrence of a pre-specified event was not answered.
Should be null or hav a value of NOT DONE]|Model v1.4[2.2.2 (Events)][--
PRESP: Used to indicate whether the event describe by --TERM was pre-
specified on a CRF. Value is Y for pre-specified events, null for spontaneously
reported events.][--OCCUR: Used to record whether a pre-specified event
occurred when information about the occurrence of a specific event is
solicited.][--STAT: Used to indicate when a question about the occurrence of a
pre-specified event was not answered . Should be null or have a value of NOT
DONE]

Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention

Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention

is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to
record whether a pre-specified event occurred when information about the
occurrence of a specific event is solicited.]|Model v1.4[2.2.2 (Events)][--
PRESP: Used to indicate whether the event describe by --TERM was pre-
specified on a CRF. Value is Y for pre-specified events, null for spontaneously
reported events.][--OCCUR: Used to record whether a pre-specified event
occurred when information about the occurrence of a specific event is
solicited.]

Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention

is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to
record whether a pre-specified event occurred when information about the
occurrence of a specific event is solicited.]|Model v1.7[2.2.2 (Events)][--
PRESP: Used to indicate whether the event describe by --TERM was pre-
specified on a CRF. Value is Y for pre-specified events, null for spontaneously
reported events.][--OCCUR: Used to record whether a pre-specified event
occurred when information about the occurrence of a specific event is
solicited.]
Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention
is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to
record whether a pre-specified event occurred when information about the
occurrence of a specific event is solicited.]|Model v1.4[2.2.2 (Events)][--
PRESP: Used to indicate whether the event describe by --TERM was pre-
specified on a CRF. Value is Y for pre-specified events, null for spontaneously
reported events.][--OCCUR: Used to record whether a pre-specified event
occurred when information about the occurrence of a specific event is
solicited.]

Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention

is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to
record whether a pre-specified event occurred when information about the
occurrence of a specific event is solicited.]|Model v1.7[2.2.2 (Events)][--
PRESP: Used to indicate whether the event describe by --TERM was pre-
specified on a CRF. Value is Y for pre-specified events, null for spontaneously
reported events.][--OCCUR: Used to record whether a pre-specified event
occurred when information about the occurrence of a specific event is
solicited.]
(--RFTDTC) Date/time for a fixed reference time point defined by --TPTREF in
ISO 8601 character format.

Date/time for a fixed reference time point defined by --TPTREF.

Model v1.4[2.2.5 Timing Variables for All Classes][Specification][(--TPTREF)

Description of the fixed reference point referred to by --ELTM, --TPTNUM, and
--TPT. Examples: PREVIOUS DOSE, PREVIOUS MEAL.]|IG v3.2[4.1.4.10
Representing Time Points][If the protocol describes the scheduling of a dose
using a reference intervention or assessment, then --TPTREF should be
populated, even if it does not contribute to uniqueness. The fact that time
points are related to a reference time point, and what that reference time point
is, are important for interpreting the data collected at the time point.]

Model v1.7[2.2.5 Timing Variables for All Classes][Table 2.2.5.1:

--TPTREF]Description of the fixed reference point referred to by --ELTM,
--TPTNUM, --TPT, --STINT, and --ENINT. Examples: "PREVIOUS DOSE",
"PREVIOUS MEAL".]|IG v3.3[4.4.10 Representing Time Points][If the protocol
describes the scheduling of a dose using a reference intervention or
assessment, then --TPTREF should be populated, even if it does not contribute
to uniqueness. The fact that time points are related to a reference time point,
and what that reference time point is, are important for interpreting the data
collected at the time point.]
(--TPTREF) Description of the fixed reference point referred to by --ELTM,
--TPTNUM, and --TPT. Examples: PREVIOUS DOSE, PREVIOUS MEAL.
Description of the fixed reference point referred to by --ELTM, --TPTNUM,
--TPT, --STINT, and --ENINT. Examples: "PREVIOUS DOSE", "PREVIOUS
MEAL".

Reason not done. Used in conjunction with --STAT when value is NOT DONE.
Reason not done. Used in conjunction with --STAT when value is "NOT
DONE".
Qualifier for anatomical location further detailing laterality.
Qualifier for anatomical location further detailing laterality.
IG v3.2[6.1][Assumption 2c][CMDECOD is the standardized medication/therapy
term derived by the sponsor from the coding dictionary. It is expected that the
reported term (CMTRT) or the modified term (CMMODIFY) will be coded using
a standard dictionary.]|IG v3.2[6.1][Specification][Standardized or dictionary-
derived text description of CMTRT or CMMODIFY. Equivalent to the generic
medication name in WHO Drug. The sponsor is expected to provide the
dictionary name and version used to map the terms utilizing the define.xml
external codelist attributes. If an intervention term does not have a decode
value in the dictionary then CMDECOD will be left blank.]

IG v3.3[6.1.2][Assumption 2c][CMDECOD is the standardized

medication/therapy term derived by the sponsor from the coding dictionary. It is
expected that the reported term (CMTRT) or the modified term (CMMODIFY)
will be coded using a standard dictionary.]|IG v3.3[6.1.2][Specification]
[Standardized or dictionary-derived text description of CMTRT or CMMODIFY.
Equivalent to the generic medication name in WHO Drug. The sponsor is
expected to provide the dictionary name and version used to map the terms
utilizing the define.xml external codelist attributes. If an intervention term does
not have a decode value in the dictionary then CMDECOD will be left blank.]
Verbatim medication name that is either pre-printed or collected on a CRF.
Verbatim medication name that is either pre-printed or collected on a CRF.
CMTRT should only include the medication/therapy name and should not
include dosage, formulation, or other qualifying information.
CMTRT should only include the medication/therapy name and should not
include dosage, formulation, or other qualifying information.
If the value for --TRT is modified for coding purposes, then the modified text is
placed here.
If the value for --TRT is modified for coding purposes, then the modified text is
placed here.

IG v3.2[6.1][Assumption 4a][For example, if 0 tablets are taken within a

Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL

IG v3.3[6.1.3.2][Assumption 4a][For example, if 0 tablets are taken within a

Doses of placebo should be represented by EXTRT = 'PLACEBO' and

EXDOSE = 0 (indicating 0 mg of active ingredient was taken or administered).

Doses of placebo should be represented by EXTRT = 'PLACEBO' and

EXDOSE = 0 (indicating 0 mg of active ingredient was taken or administered).
Units ... representing protocol-specified values.
Units ... representing protocol-specified values.
Name of the protocol-specified study treatment given during the dosing period
for the observation.
Name of the protocol-specified study treatment given during the dosing period
for the observation.
When the EC domain (See Section 6.1.2.3) is implemented in conjunction with
the EX domain, EXVAMT and EXVAMTU should not be used in EX; collected
values instead would be represented in ECDOSE and ECDOSU
When the EC domain is implemented in conjunction with the EX domain,
EXVAMT and EXVAMTU should not be used in EX; collected values instead
would be represented in ECDOSE and ECDOSU.
[--TRTV:Vehicle for administration of treatment, such as a liquid in which the
treatment drug is dissolved. Example: SALINE.][--VAMT: Amount of the
prepared product (treatment + vehicle) administered or given. Note: should not
be diluent amount alone.][--VAMTU: Units for the prepared product (treatment
+ vehicle). Examples: mL, mg.]
[--TRTV:Vehicle for administration of treatment, such as a liquid in which the
treatment drug is dissolved. Example: SALINE.][--VAMT: Amount of the
prepared product (treatment + vehicle) administered or given. Note: should not
be diluent amount alone.][--VAMTU: Units for the prepared product (treatment
+ vehicle). Examples: mL, mg.]
When the EC domain (See Section 6.1.2.3) is implemented in conjunction with
the EX domain, EXVAMT and EXVAMTU should not be used in EX; collected
values instead would be represented in ECDOSE and ECDOSU
When the EC domain (See Section 6.1.2.3) is implemented in conjunction with
the EX domain, EXVAMT and EXVAMTU should not be used in EX; collected
values instead would be represented in ECDOSE and ECDOSU
--TRTV:Vehicle for administration of treatment, such as a liquid in which the
treatment drug is dissolved. Example: SALINE. --VAMT: Amount of the
prepared product (treatment + vehicle) administered or given. Note: should not
be diluent amount alone. --VAMTU: Units for the prepared product (treatment +
vehicle). Examples: mL, mg.
--TRTV:Vehicle for administration of treatment, such as a liquid in which the
treatment drug is dissolved. Example: SALINE. --VAMT: Amount of the
prepared product (treatment + vehicle) administered or given. Note: should not
be diluent amount alone. --VAMTU: Units for the prepared product (treatment +
vehicle). Examples: mL, mg.

Specification[ACTARMCD: Randomized subjects who were not treated will be

given a value of NOTTRT. Values should be "SCRNFAIL" for screen failures
and "NOTASSGN" for subjects not assigned to treatment]|Assumption
4[Subjects withdrawn from a trial before assignment to an Arm, if they are not
screen failures, should have ARMCD = 'NOTASSGN' and ARM = 'Not
Assigned'.]|Assumption 10[subjects who are ineligible for treatment (e.g.,
screen failures with ARMCD=SCRNFAIL), subjects who were enrolled but not
assigned to an arm (ARMCD=NOTASSGN), or subjects who were randomized
but not treated (ACTARMCD=NOTTRT), RFSTDTC will be null.]
Amount of --TRT when numeric. Not populated when --DOSTXT is populated.
Amount of --TRT when numeric. Not populated when --DOSTXT is populated.
Amount of --TRT when non-numeric. Dosing amounts or a range of dosing
information collected in text form. Example: 200-400. Not populated when
--DOSE is populated.
Dosing information collected in text form. Examples: <1 per day, 200-400. Not
populated when --DOSE is populated.
Dosing information collected in text form. Examples: <1 per day, 200-400. Not
populated when --DOSE is populated.
Dosing information collected in text form. Examples: <1 per day, 200-400. Not
populated when --DOSE is populated.
Units for --DOSE, --DOSTOT, or --DOSTXT (Examples: ng, mg, mg/kg).
Units for --DOSE, --DOSTOT, or --DOSTXT. Examples: "ng", "mg", "mg/kg".
Qualifier for anatomical location further detailing the distribution, which means
arrangement of, apportioning of the intervention administration.
Qualifier for anatomical location further detailing the distribution, which means
arrangement of, apportioning of the intervention administration.

Qualifier for anatomical location further detailing directionality ...

Description of actual Arm. When an Arm is not planned (not in Trial Arms),
ACTARM will be “Unplanned Treatment”. Randomized subjects who were not
treated will be given a value of “Not Treated”. Values should be “Screen
Failure” for screen failures and “Not Assigned” for subjects not assigned to
treatment. Restricted to values in Trial Arms in all other cases.
Description of actual Arm. When an Arm is not planned (not in Trial Arms),
ACTARM will be “Unplanned Treatment”. Randomized subjects who were not
treated will be given a value of “Not Treated”. Values should be “Screen
Failure” for screen failures and “Not Assigned” for subjects not assigned to
treatment. Restricted to values in Trial Arms in all other cases.
Values should be "Screen Failure" for screen failures and "Not Assigned" for
subjects not assigned to treatment.
Name of the Arm to which the subject was assigned.
Name of the Arm to which the subject was assigned.
Data for screen failure subjects, if submitted, should be included in the
Demographics dataset, with ARMCD = "SCRNFAIL' and ARM = "Screen
Failure". Subjects withdrawn from a trial before assignment to an Arm, if they
are not screen failures, should have ARMCD ='NOTASSGN' and ARM = 'Not
Assigned'.
ACTARMCD is limited to 20 characters and does not have special character
restrictions.
Code of actual Arm. ACTARMCD is limited to 20 characters. It is not subject to
the character restrictions that apply to TESTCD.
Code of actual Arm. When an Arm is not planned (not in Trial Arms),
ACTARMCD will be UNPLAN. Randomized subjects who were not treated will
be given a value of NOTTRT. Values should be "SCRNFAIL" for screen failures
and "NOTASSGN" for subjects not assigned to treatment. Restricted to values
in Trial Arms in all other cases
Code of actual Arm. When an Arm is not planned (not in Trial Arms),
ACTARMCD will be UNPLAN. Randomized subjects who were not treated will
be given a value of NOTTRT. Values should be "SCRNFAIL" for screen failures
and "NOTASSGN" for subjects not assigned to treatment. Restricted to values
in Trial Arms in all other cases
Data for screen failure subjects, if submitted, should be included in the
Demographics dataset, with ARMCD = "SCRNFAIL' and ARM = "Screen
Failure". Subjects withdrawn from a trial before assignment to an Arm, if they
are not screen failures, should have ARMCD ='NOTASSGN' and ARM = 'Not
Assigned'.
Values should be "SCRNFAIL" for screen failures and "NOTASSGN" for
subjects not assigned to treatment.
Data for screen failure subjects, if submitted, should be included in the
Demographics dataset, with ARMCD = "SCRNFAIL' and ARM = "Screen
Failure". Subjects withdrawn from a trial before assignment to an Arm, if they
are not screen failures, should have ARMCD ='NOTASSGN' and ARM = 'Not
Assigned'.
Values should be "SCRNFAIL" for screen failures and "NOTASSGN" for
subjects not assigned to treatment.
Should be Y or null.
Should be "Y" or null.
For example, if a subject's Survival Status is "DEAD", the date of death must
be stored in DM and within a final disposition record in DS.
For example, if a subject's Survival Status is "DEAD", the date of death must
be stored in DM and within a final disposition record in DS.
Specification[Indicates the subject died. Should be Y or null. Should be
populated even when the death date is unknown.]|DD Assumption 1[This
domain captures information pertaining to the death of a subject, including the
causes of death.]
IG v3.3[5.2][Indicates the subject died. Should be Y or null. Should be
populated even when the death date is unknown.]||IG v3.3[6.3.2][A findings
domain that contains the diagnosis of the cause of death for a subject]
Indicates the subject died. Should be Y or null. Should be populated even
when the death date is unknown.
Indicates the subject died. Should be Y or null. Should be populated even
when the death date is unknown.
Indicates the subject died. Should be Y or null. Should be populated even
when the death date is unknown.
Indicates the subject died. Should be Y or null. Should be populated even
when the death date is unknown.
Indicates the subject died. Should be Y or null. Should be populated even
when the death date is unknown.
Indicates the subject died. Should be Y or null. Should be populated even
when the death date is unknown.
When study population flags are included in SDTM, they are treated as
Supplemental Qualifiers (see Section 8: 8.4, Relating Non-Standard Variables
Values To A Parent Domain) to DM and placed in the SUPPDM dataset.
Controlled terms for these subject-level population flags, (e.g., COMPLT,
SAFETY, ITT and PPROT) are listed in Appendix C2 - Supplemental Qualifier
Name Codes.
If multiple races are collected then the value of RACE should be 'MULTIPLE'
and the additional information will be included in the Supplemental Qualifiers
dataset.

IG v3.2[5][Specification: RFENDTC][Required for all randomized subjects; null

for screen failures or unassigned subjects.]|IG v3.2[5][Specification: ACTARM]
[Randomized subjects who were not treated will be given a value of “Not
Treated”. Values should be “Screen Failure” for screen failures and “Not
Assigned” for subjects not assigned to treatment.]|IG v3.2[5][Assumption 10]
[This definition applies for most interventional studies, when the start of
treatment is the natural and preferred starting point for study day variables and
thus the logical value for RFSTDTC. In such studies, when data are submitted
for subjects who are ineligible for treatment (e.g., screen failures with
ARMCD=SCRNFAIL), subjects who were enrolled but not assigned to an arm
(ARMCD=NOTASSGN), or subjects who were randomized but not treated
(ACTARMCD=NOTTRT), RFSTDTC will be null.]
IG v3.2[5][Specification: RFENDTC][Required for all randomized subjects; null
for screen failures or unassigned subjects.]|IG v3.2[5][Specification: ACTARM]
[Randomized subjects who were not treated will be given a value of “Not
Treated”. Values should be “Screen Failure” for screen failures and “Not
Assigned” for subjects not assigned to treatment.]|IG v3.2[5][Assumption 10]
[This definition applies for most interventional studies, when the start of
treatment is the natural and preferred starting point for study day variables and
thus the logical value for RFSTDTC. In such studies, when data are submitted
for subjects who are ineligible for treatment (e.g., screen failures with
ARMCD=SCRNFAIL), subjects who were enrolled but not assigned to an arm
(ARMCD=NOTASSGN), or subjects who were randomized but not treated
(ACTARMCD=NOTTRT), RFSTDTC will be null.]

Specification[This will be the same as the date of informed consent in the

Disposition domain, if that protocol milestone is documented. Would be null
only in studies not collecting the date of informed consent.]|Assumption
13[RFICDTC should correspond to the date of the informed . . . In the event
that there are multiple informed consents, this will be the date of the first one.]
Specification[This will be the same as the date of informed consent in the
Disposition domain, if that protocol milestone is documented. Would be null
only in studies not collecting the date of informed consent.]|Assumption 10c[In
the event that there are multiple informed consents, this will be the date of the
first one.]

Null for screen failures or unassigned subjects.

Required for all randomized subjects.

Equal to the latest value of EXENDTC (or the latest value of EXSTDTC if
EXENDTC was not collected or is missing).
Equal to the latest value of EXENDTC (or the latest value of EXSTDTC if
EXENDTC was not collected or is missing).
First date of exposure to any protocol-specified treatment or therapy, equal to
the earliest value of EXSTDTC.
First date of exposure to any protocol-specified treatment or therapy, equal to
the earliest value of EXSTDTC.
Maximum of 8 characters.
Maximum of 8 characters.
Subject identifier, which must be unique within the study.
Subject identifier, which must be unique within the study.
Identifier used to uniquely identify a subject across all studies
Identifier used to uniquely identify a subject across all studies
The name of the Element. If ETCD has a value of "UNPLAN" then ELEMENT
should be null.
The name of the Element. If ETCD has a value of "UNPLAN" then ELEMENT
should be null.
ARMCD is limited to 20 characters and does not have special character
restrictions.
ARMCD is limited to 20 characters and does not have special character
restrictions.
ETCD (the companion to ELEMENT) is limited to 8 characters and does not
have special character restrictions.
ETCD (the companion to ELEMENT) is limited to 8 characters and does not
have special character restrictions.

[Associated Persons datasets are given a prefix of AP-- to identify the data as
AP data to and distinguish them from study subject data.][Associated Persons
domain codes in the DOMAIN column of every record are also given a prefix of
AP-- to identify the domains as AP domains and to distinguish them from study
subject domains. AP domain codes are therefore four characters long.]
Identifier for a single associated person, a group of associated persons, or a
pool of associated persons. If APID identifies a pool, POOLDEF records must
exist for each associated person.
Identifier for a single associated person, a group of associated persons, or a
pool of associated persons. If APID identifies a pool, POOLDEF records must
exist for each associated person.
RSUBJID will be populated with the USUBJID of the related subject or the
POOLID of the related pool.
RSUBJID will be populated with the USUBJID of the related subject or the
POOLID of the related pool.
RSUBJID will be populated with the USUBJID of the related subject or the
POOLID of the related pool.
RSUBJID will be populated with the USUBJID of the related subject or the
POOLID of the related pool.
RSUBJID will be populated with the USUBJID of the related subject or the
POOLID of the related pool.
RSUBJID will be populated with the USUBJID of the related subject or the
POOLID of the related pool.
If RSUBJID is populated, describes the relationship of the associated person(s)
identified in APID to the subject or pool identified in RSUBJID. If RDEVID is
populated, describes the relationship of the associated person(s) identified in
APID to the device identified in RDEVID. If RSUBJID and RDEVID are null,
SREL describes the relationship of the associated person(s) identified in APID
to the study identified in STUDYID
If RSUBJID is populated, describes the relationship of the associated person(s)
identified in APID to the subject or pool identified in RSUBJID. If RDEVID is
populated, describes the relationship of the associated person(s) identified in
APID to the device identified in RDEVID. If RSUBJID and RDEVID are null,
SREL describes the relationship of the associated person(s) identified in APID
to the study identified in STUDYID
If RSUBJID is populated, describes the relationship of the associated person(s)
identified in APID to the subject or pool identified in RSUBJID. If RDEVID is
populated, describes the relationship of the associated person(s) identified in
APID to the device identified in RDEVID. If RSUBJID and RDEVID are null,
SREL describes the relationship of the associated person(s) identified in APID
to the study identified in STUDYID
If RSUBJID is populated, describes the relationship of the associated person(s)
identified in APID to the subject or pool identified in RSUBJID. If RDEVID is
populated, describes the relationship of the associated person(s) identified in
APID to the device identified in RDEVID. If RSUBJID and RDEVID are null,
SREL describes the relationship of the associated person(s) identified in APID
to the study identified in STUDYID
If RSUBJID is populated, describes the relationship of the associated
person(s) identified in APID to the subject or pool identified in RSUBJID. If
RDEVID is populated, describes the relationship of the associated person(s)
identified in APID to the device identified in RDEVID. If RSUBJID and RDEVID
are null, SREL describes the relationship of the associated person(s) identified
in APID to the study identified in STUDYID
If RSUBJID is populated, describes the relationship of the associated person(s)
identified in APID to the subject or pool identified in RSUBJID. If RDEVID is
populated, describes the relationship of the associated person(s) identified in
APID to the device identified in RDEVID. If RSUBJID and RDEVID are null,
SREL describes the relationship of the associated person(s) identified in APID
to the study identified in STUDYID
Identifying variable in the parent dataset that identifies the record(s) to which
the comment applies. Examples AESEQ or CMGRPID. Used only when
individual comments are related to domain records. null for comments collected
on separate CRFs.
Identifying variable in the parent dataset that identifies the record(s) to which
the comment applies. Examples AESEQ or CMGRPID. Used only when
individual comments are related to domain records. null for comments collected
on separate CRFs.
Identifying variable in the parent dataset that identifies the record(s) to which
the comment applies. Examples AESEQ or CMGRPID. Used only when
individual comments are related to domain records. null for comments collected
on separate CRFs.
Identifying variable in the parent dataset that identifies the record(s) to which
the comment applies. Examples AESEQ or CMGRPID. Used only when
individual comments are related to domain records. null for comments collected
on separate CRFs.
Value of identifying variable of the parent record(s). Used only when individual
comments are related to domain records. null for comments collected on
separate CRFs.
Value of identifying variable of the parent record(s). Used only when individual
comments are related to domain records. null for comments collected on
separate CRFs.
The Comments special-purpose domain provides a solution for submitting free-
text comments related to data in one or more SDTM domains (as described in
Section 8: 8.5, Relating Comments To A Parent Domain) or collected on a
separate CRF page dedicated to comments. Comments are generally not
responses to specific questions; instead, comments usually consist of
voluntary, free-text or unsolicited observations.
The Comments special-purpose domain provides a solution for submitting free-
text comments related to data in one or more SDTM domains (as described in
Section 8: 8.5, Relating Comments To A Parent Domain) or collected on a
separate CRF page dedicated to comments. Comments are generally not
responses to specific questions; instead, comments usually consist of
voluntary, free-text or unsolicited observations.

[Date/time of comment on dedicated comment form. Should be null if this is a

child record of another domain or if comment date was not collected.][Those
related to a specific parent record or group of parent records, in which case the
value of the variable RDOMAIN is set to the DOMAIN code of the parent
record(s) and the variables IDVAR and IDVARVAL are populated with the key
variable name and value of the parent record(s).][Assumptions for populating
IDVAR and IDVARVAL are further described in Section 8: 8.5, Relating
Comments To A Parent Domain. CODTC should be null because the timing of
the parent record(s) is inherited by the comment record. See example, Rows 3-
5.]
When the comment text is longer than 200 characters, the first 200 characters
of the comment will be in COVAL, the next 200 in COVAL1, and additional text
stored as needed to COVALn. See example, Rows 3-4.
When the comment text is longer than 200 characters, the first 200 characters
of the comment will be in COVAL, the next 200 in COVAL1, and additional text
stored as needed to COVALn. See example, Rows 3-4.

Subject Status does not contain details about the circumstances of a subject's
status. The response to the status assessment may trigger collection of
additional details but those details are to be stored in appropriate separate
domains. For example, if a subject's Survival Status is "DEAD", the date of
death must be stored in DM and within a final disposition record in DS. Only
the status collection date, the status question and the status response are
stored in SS.
Subject Status does not contain details about the circumstances of a subject's
status. The response to the status assessment may trigger collection of
additional details but those details are to be stored in appropriate separate
domains. For example, if a subject's Survival Status is "DEAD", the date of
death must be stored in DM and within a final disposition record in DS. Only
the status collection date, the status question and the status response are
stored in SS.

Subject Status does not contain details about the circumstances of a subject’s
status. The response to the status assessment may trigger collection of
additional details but those details are to be stored in appropriate separate
domains. For example, if a subject’s Survival Status is “DEAD”, the date of
death must be stored in DM and within a final disposition record in DS. Only
the status collection date, the status question and the status response are
stored in SS.
When collected data fit a Qualifier variable listed in SDTM: Sections 2.2.1,
2.2.2, or 2.2.3, and are represented in the Findings About domain, then the
name of the variable should be used as the value of FATESTCD.
When collected data fit a Qualifier variable listed in SDTM: Sections 2.2.1,
2.2.2, or 2.2.3, and are represented in the Findings About domain, then the
name of the variable should be used as the value of FATESTCD.
In general, the value in FAOBJ should match the value in --TERM or --TRT,
unless the parent domain is dictionary coded or subject to controlled
terminology, in which case FAOBJ should then match the value in --DECOD.
In general, the value in FAOBJ should match the value in --TERM or --TRT,
unless the parent domain is dictionary coded or subject to controlled
terminology, in which case FAOBJ should then match the value in --DECOD.
The intent of the domain model is to collect response to only those criteria that
the subject did not meet, and not the responses to all criteria.
The intent of the domain model is to collect response to only those criteria that
the subject did not meet, and not the responses to all criteria.
The intent of the domain model is to collect response to only those criteria that
the subject did not meet, and not the responses to all criteria.
The intent of the domain model is to collect response to only those criteria that
the subject did not meet, and not the responses to all criteria.
Response to Inclusion/Exclusion criterion result in standard format.
Response to Inclusion/Exclusion criterion result in standard format.
The complete list of Inclusion/Exclusion criteria can be found in the TI trial
inclusion/exclusion criteria dataset described in Section 7.4 - Trial Summary
and Eligibility: Trial Inclusion/Exclusion Criteria (TI).
The complete list of Inclusion/Exclusion criteria can be found in the TI trial
inclusion/exclusion criteria dataset described in Section 7.4 - Trial Summary
and Eligibility: Trial Inclusion/Exclusion Criteria (TI).
The complete list of Inclusion/Exclusion criteria can be found in the TI trial
inclusion/exclusion criteria dataset described in Section 7.4 - Trial Summary
and Eligibility: Trial Inclusion/Exclusion Criteria (TI).
The complete list of Inclusion/Exclusion criteria can be found in the Trial
Inclusion/Exclusion Criteria (TI) dataset described in Section 7.4.1, Trial
Inclusion/Exclusion Criteria.
Lower end of reference range for continuous measurements in original units.
Should be populated only for continuous results.
Lower end of reference range for continuous measurements in original units.
Should be populated only for continuous results.
Upper end of reference range for continuous measurements in original units.
Should be populated only for continuous results.
Upper end of reference range for continuous measurements in original units.
Should be populated only for continuous results.
Lower end of reference range for continuous measurements in original units.
Should be populated only for continuous results.
Lower end of reference range for continuous measurements in original units.
Should be populated only for continuous results.
Upper end of reference range for continuous measurements in original units.
Should be populated only for continuous results.
Upper end of reference range for continuous measurements in original units.
Should be populated only for continuous results.
For normal range values that are character in ordinal scale or if categorical
ranges were supplied (e.g., "-1 to +1", "NEGATIVE TO TRACE").
For normal range values that are character in ordinal scale or if categorical
ranges were supplied (e.g., "-1 to +1", "NEGATIVE TO TRACE").
If value is from a numeric scale, represent only the number (e.g., "2" and not
"Grade 2").
If value is from a numeric scale, represent only the number (e.g., "2" and not
"Grade 2").
Lower end of reference range for continuous measurements in original units.
Lower end of reference range for continuous measurements in original units.
Upper end of reference range for continuous measurements in original units.
Upper end of reference range for continuous measurements in original units.
Lower end of reference range for continuous measurements for
LBSTRESC/LBSTRESN in standardized units.
Lower end of reference range for continuous measurements for
LBSTRESC/LBSTRESN in standardized units.
Upper end of reference range for continuous measurements in standardized
units.
Upper end of reference range for continuous measurements in standardized
units.
Reference Range for Char Rslt-Std Units
Reference Range for Char Rslt-Std Units
2.6[Item 1, Bullet 5][The domain pair uses DOMAIN as an Identifier to group
parent records (e.g., MB) from child records (e.g., MS) and enables a dataset-
level relationship to be described in RELREC.]|6.3[MS Assumption 1]
[Definition: The MS domain is designed to store any findings related to the
organisms found and submitted in MB.]
2.6[Item 1][The domain pair uses DOMAIN as an Identifier to group parent
records (e.g., MB) from child records (e.g., MS) and enables a dataset-level
relationship to be described in RELREC.]|6.3.7[MS is used for representing
data from drug susceptibility testing on the organisms identified in MB.]

3. MBTESTCD value for organisms present in a specimen is 'ORGANISM'.

MBRESCAT is expected in all records where a microorganism has been
identified to differentiate between colonizing organisms and the one(s) that are
causing the infection. It is not expected when there is “No growth” or when the
results are from a gram stain.
Text description of any abnormal findings. If the examination was completed
and there were no abnormal findings, the value should be NORMAL.
Text description of any abnormal findings. If the examination was completed
and there were no abnormal findings, the value should be NORMAL.
If there are findings for a body system, then either the dictionary preferred term
(if findings are coded using a dictionary) or PEORRES (if findings are not
coded) should appear here.
If there are findings for a body system, then either the dictionary preferred term
(if findings are coded using a dictionary) or PEORRES (if findings are not
coded) should appear here.
Relationships represented in RELREC are collected relationships, either by
explicit references or check boxes on the CRF, or by design of the CRF, such
as vital signs captured during an exercise stress test.
Relationships represented in RELREC are collected relationships, either by
explicit references or check boxes on the CRF, or by design of the CRF, such
as vital signs captured during an exercise stress test.
All records for the same USUBJID that have the same RELID are considered
"related/associated."
All records for the same USUBJID that have the same RELID are considered
"related/associated."
This example shows how to use the RELREC dataset to represent related
information that is submitted as two datasets that have a one-to-many
relationship. in the example below all the records in one domain are being
related to all of the records in the other, so both USUBJID and IDVARVAL are
null.
This example shows how to use the RELREC dataset to represent related
information that is submitted as two datasets that have a one-to-many
relationship. in the example below all the records in one domain are being
related to all of the records in the other, so both USUBJID and IDVARVAL are
null.
For objective data, the value in QEVAL will be null. For subjective data (when
QORIG=”ASSIGNED”), the value in QEVAL should reflect the role of the
person or institution assigning the value (e.g., SPONSOR or ADJUDICATION
COMMITTEE).
For objective data, the value in QEVAL will be null. For subjective data (when
QORIG=”ASSIGNED”), the value in QEVAL should reflect the role of the
person or institution assigning the value (e.g., SPONSOR or ADJUDICATION
COMMITTEE).

A record in a SUPP-- dataset relates back to its parent record(s) via the key
identified by the STUDYID, RDOMAIN,and IDVAR/IDVARVAL variables. An
exception is SUPP-- dataset records that are related to Demographics (DM)
records, such as the Intent To Treat (ITT) and Safety (SAFETY) subject-level
population flags, where both IDVAR and IDVARVAL will be null because the
key variables STUDYID, RDOMAIN, and USUBJID are sufficient to identify the
unique parent record in DM (DM has one record per USUBJID).
A record in a SUPP-- dataset relates back to its parent record(s) via the key
identified by the STUDYID, RDOMAIN,and IDVAR/IDVARVAL variables. An
exception is SUPP-- dataset records that are related to Demographics (DM)
records, such as the Intent To Treat (ITT) and Safety (SAFETY) subject-level
population flags, where both IDVAR and IDVARVAL will be null because the
key variables STUDYID, RDOMAIN, and USUBJID are sufficient to identify the
unique parent record in DM (DM has one record per USUBJID).

When data have been split into multiple datasets (see Section 4: 4.1.1.7,
Splitting Domains), longer names such as SUPPFAMH may be needed. in
cases where data about Associated Persons (see Associated Persons
Implementation Guide) have been collected, an associated person with
Supplemental Qualifiers for Findings About their medical history, the resulting
dataset name SUPPAPFAMH) would be too long so that, in this case only, the
"SUPP" portion should be shortened to "SQ". resulting in a dataset name of
SQAPFAMH.

TAETORD will not be populated for subject Elements that are not planned for
the Arm to which the subject was assigned. Thus, TAETORD will not be
populated for any Element with an ETCD value of "UNPLAN". TAETORD will
also not be populated if a subject passed through an Element that, although
defined in the TE dataset, was out of place for the Arm to which the subject
was assigned. For example, if a subject in a parallel study of Drug A vs. Drug B
was assigned to receive Drug A, but received Drug B instead, then TAETORD
would be left blank for the SE record for their Drug B Element. If a subject was
assigned to receive the sequence of Elements A, B, C, D, and instead received
A, D, B, C, then the sponsor would have to decide for which of these subject
Element records TAETORD should be populated. The rationale for this
decision should be documented in the Comments column of the define.xml.
TAETORD will not be populated for subject Elements that are not planned for
the Arm to which the subject was assigned. Thus, TAETORD will not be
populated for any Element with an ETCD value of "UNPLAN". TAETORD will
also not be populated if a subject passed through an Element that, although
defined in the TE dataset, was out of place for the Arm to which the subject
was assigned. For example, if a subject in a parallel study of Drug A vs. Drug B
was assigned to receive Drug A, but received Drug B instead, then TAETORD
would be left blank for the SE record for their Drug B Element. If a subject was
assigned to receive the sequence of Elements A, B, C, D, and instead received
A, D, B, C, then the sponsor would have to decide for which of these subject
Element records TAETORD should be populated. The rationale for this
decision should be documented in the Comments column of the define.xml.
Since there are, by definition, no gaps between Elements, the value of
SEENDTC for one Element will always be the same as the value of SESTDTC
for the next Element
Since there are, by definition, no gaps between Elements, the value of
SEENDTC for one Element will always be the same as the value of SESTDTC
for the next Element

Note that SESTDTC is required, although --STDTC is not required in any other
subject-level dataset. The purpose of the dataset is to record the Elements a
subject actually passed through. We assume that if it is known that a subject
passed through a particular Element, then there must be some information on
when it started, even if that information is imprecise. Thus, SESTDTC may not
be null, although some records may not have all the components (e.g., year,
month, day, hour, minute) of the date/time value collected.

Assumption 10[Since there are, by definition, no gaps between Elements, the

value of SEENDTC for one Element will always be the same as the value of
SESTDTC for the next Element.]|Assumption 11[Note that SESTDTC is
required, although --STDTC is not required in any other subject-level dataset.
The purpose of the dataset is to record the Elements a subject actually passed
through. We assume that if it is known that a subject passed through a
particular Element, then there must be some information on when it started,
even if that information is imprecise. Thus, SESTDTC may not be null, although
some records may not have all the components (e.g., year, month, day, hour,
minute) of the date/time value collected.]
Assumption 8[Since there are, by definition, no gaps between Elements, the
value of SEENDTC for one Element will always be the same as the value of
SESTDTC for the next Element.]|Assumption 9[Note that SESTDTC is
required, although --STDTC is not required in any other subject-level dataset.
The purpose of the dataset is to record the Elements a subject actually passed
through. We assume that if it is known that a subject passed through a
particular Element, then there must be some information on when it started,
even if that information is imprecise. Thus, SESTDTC may not be null, although
some records may not have all the components (e.g., year, month, day, hour,
minute) of the date/time value collected.]
If the sponsor decides that the subject's experience for a particular period of
time cannot be represented with one of the planned Elements, then that period
of time should be represented as an unplanned Element. The value of ETCD
for an unplanned Element is "UNPLAN" and SEUPDES should be populated
with a description of the unplanned Element only if ETCD has the value of
"UNPLAN".
If the sponsor decides that the subject's experience for a particular period of
time cannot be represented with one of the planned Elements, then that period
of time should be represented as an unplanned Element. The value of ETCD
for an unplanned Element is "UNPLAN" and SEUPDES should be populated
with a description of the unplanned Element only if ETCD has the value of
"UNPLAN".
If the sponsor decides that the subject's experience for a particular period of
time cannot be represented with one of the planned Elements, then that period
of time should be represented as an unplanned Element. The value of ETCD
for an unplanned Element is "UNPLAN" and SEUPDES should be populated
with a description of the unplanned Element only if ETCD has the value of
"UNPLAN".
If the sponsor decides that the subject's experience for a particular period of
time cannot be represented with one of the planned Elements, then that period
of time should be represented as an unplanned Element. The value of ETCD
for an unplanned Element is "UNPLAN" and SEUPDES should be populated
with a description of the unplanned Element only if ETCD has the value of
"UNPLAN".
The method for deriving these values should be consistent with the visit
definitions in the Trial Visits dataset [see Section 7.3 - Schedule for
Assessments: Trial Visits (TV)].
The method for deriving these values should be consistent with the visit
definitions in the Trial Visits (TV) dataset (Section 7.3.1, Trial Visits).

Records for unplanned visits should be included in the SV dataset. For

unplanned visits, SVUPDES should be populated with a description of the
reason for the unplanned visit. Some judgment may be required to determine
what constitutes an unplanned visit. When data are collected outside a planned
visit, that act of collecting data may or may not be described as a 'visit.' The
encounter should generally be treated as a visit if data from the encounter are
included in any domain for which VISITNUM is included, since a record with a
missing value for VISITNUM is generally less useful than a record with
VISITNUM populated. If the occasion is considered a visit, its date/times must
be included in the SV table and a value of VISITNUM must be assigned. See
Section 4: 4.1.4.5, Clinical Encounters And Visits for information on the
population of visit variables for unplanned visits.
Records for unplanned visits should be included in the SV dataset. For
unplanned visits, SVUPDES should be populated with a description of the
reason for the unplanned visit. Some judgment may be required to determine
what constitutes an unplanned visit. When data are collected outside a planned
visit, that act of collecting data may or may not be described as a 'visit.' The
encounter should generally be treated as a visit if data from the encounter are
included in any domain for which VISITNUM is included, since a record with a
missing value for VISITNUM is generally less useful than a record with
VISITNUM populated. If the occasion is considered a visit, its date/times must
be included in the SV table and a value of VISITNUM must be assigned. See
Section 4.4.5, Clinical Encounters And Visits for information on the population
of visit variables for unplanned visits.
Protocol-defined description of clinical encounter.
Protocol-defined description of clinical encounter.
Planned study day of the start of the visit based upon RFSTDTC in
Demographics. Should not be populated for Unplanned Visits
VISITDY is the Planned Study Day of a visit. It should not be populated for
unplanned visits.
If TAETORD and/or EPOCH are added, then the values must be those at the
start of the visit.It would be inappropriate to add the variables that support time
points (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic
of this dataset is visits.
If TAETORD and/or EPOCH are added, then the values must be those at the
start of the visit.It would be inappropriate to add the variables that support time
points (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic
of this dataset is visits.
If TAETORD and/or EPOCH are added, then the values must be those at the
start of the visit.It would be inappropriate to add the variables that support time
points (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic
of this dataset is visits.
If TAETORD and/or EPOCH are added, then the values must be those at the
start of the visit.It would be inappropriate to add the variables that support time
points (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic
of this dataset is visits.
In general, all domains based on the three general observation classes should
have at least one Timing variable. in the Events or Interventions general
observation class this could be the start date of the event or intervention. in the
Findings observation class where data are usually collected at multiple visits, at
least one Timing variable must be used.
Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM
subject-level domain datasets. In general, all domains based on the three
general observation classes should have at least one Timing variable. In the
Events or Interventions general observation class, this could be the start date
of the event or intervention. In the Findings observation class, where data are
usually collected at multiple visits, at least one Timing variable must be used
[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the
relative day of the observation starting with the reference date as Day 1. They
are determined by comparing the date portion of the respective date/time
variables (--DTC, --STDTC, and --ENDTC) to the date portion of the Subject
Reference Start Date (RFSTDTC from the Demographics domain).][All Study
Day values are integers. Thus, to calculate Study Day: --DY = (date portion of
--DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY
= (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes
RFSTDTC. This algorithm should be used across all domains.]

[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the
relative day of the observation starting with the reference date as Day 1. They
are determined by comparing the date portion of the respective date/time
variables (--DTC, --STDTC, and --ENDTC) to the date portion of the Subject
Reference Start Date (RFSTDTC from the Demographics domain).][All Study
Day values are integers. Thus, to calculate Study Day: --DY = (date portion of
--DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY
= (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes
RFSTDTC. This algorithm should be used across all domains.]
VISITDY must not be populated for unplanned visits, since VISITDY is, by
definition, the planned study day of visit, and since the actual study day of an
unplanned visit belongs in a --DY variable.
VISITDY must not be populated for unplanned visits, since VISITDY is, by
definition, the planned study day of visit, and since the actual study day of an
unplanned visit belongs in a --DY variable.
Identifies the start of the observation as being before, during, or after the
sponsor-defined reference period. The sponsor-defined reference period is a
continuous period of time defined by a discrete starting point and a discrete
ending point represented by RFSTDTC and RFENDTC in Demographics.
Identifies the start of the observation as being before, during, or after the
sponsor-defined reference period. The sponsor-defined reference period is a
continuous period of time defined by a discrete starting point and a discrete
ending point represented by RFSTDTC and RFENDTC in Demographics.
Identifies the end of the observation as being before, during or after the
sponsor-defined reference period. The sponsor-defined reference period is a
continuous period of time defined by a discrete starting point and a discrete
ending point represented by RFSTDTC and RFENDTC in Demographics.
Identifies the end of the observation as being before, during or after the
sponsor-defined reference period. The sponsor-defined reference period is a
continuous period of time defined by a discrete starting point and a discrete
ending point represented by RFSTDTC and RFENDTC in Demographics.

If the reference time point corresponds to the date of collection or assessment:

Start values: an observation can start BEFORE that time point, can start
COINCIDENT with that time point, or it is unknown (U) when it started. End
values: an observation can end BEFORE that time point, can end
COINCIDENT with that time point, can be known that it didn't end but was
ONGOING, or it is unknown (U) at all when it ended or if it was ongoing.
AFTER is not a valid value in this case because it would represent an event
after the date of collection.
If the reference time point is prior to the date of collection or assessment: Start
values: an observation can start BEFORE the reference point, can start
COINCIDENT with the reference point, can start AFTER the reference point, or
it may not be known (U) when it started. End values: an observation can end
BEFORE the reference point, can end COINCIDENT with the reference point,
can end AFTER the reference point, can be known that it didn't end but was
ONGOING, or it is unknown (U) when it ended or if it was ongoing.

If the reference time point is prior to the date of collection or assessment: Start
values: an observation can start BEFORE the reference point, can start
COINCIDENT with the reference point, can start AFTER the reference point, or
it may not be known (U) when it started. End values: an observation can end
BEFORE the reference point, can end COINCIDENT with the reference point,
can end AFTER the reference point, can be known that it didn't end but was
ONGOING, or it is unknown (U) when it ended or if it was ongoing.
For any domain based on the Findings general observation class, such as lab
tests which are based on a specimen, the collection date is likely to be tied to
when the specimen or source of the finding was captured, not necessarily
when the data was recorded. in order to ensure that the critical timing
information is always represented in the same variable, the --DTC variable is
used to represent the time of specimen collection.
For any domain based on the Findings general observation class, such as lab
tests which are based on a specimen, the collection date is likely to be tied to
when the specimen or source of the finding was captured, not necessarily
when the data were recorded. In order to ensure that the critical timing
information is always represented in the same variable, the --DTC variable is
used to represent the time of specimen collection.
For any domain based on the Findings general observation class, such as lab
tests which are based on a specimen, the collection date is likely to be tied to
when the specimen or source of the finding was captured, not necessarily
when the data was recorded. in order to ensure that the critical timing
information is always represented in the same variable, the --DTC variable is
used to represent the time of specimen collection.
For any domain based on the Findings general observation class, such as lab
tests which are based on a specimen, the collection date is likely to be tied to
when the specimen or source of the finding was captured, not necessarily
when the data were recorded. In order to ensure that the critical timing
information is always represented in the same variable, the --DTC variable is
used to represent the time of specimen collection.
Dates are generally used only as timing variables, ... but there may be
occasions when it may be preferable to model a date as a result (--ORRES) in
a Findings dataset. ... this situation may occasionally occur when a) a group of
questions (each of which has a date response) is asked and analyzed together;
or b) the Event(s) and Intervention(s) in question are not medically significant
(often the case when included in questionnaires). Consider the following cases:
Calculated due date; Date of last day on the job; Date of high school
graduation. One approach to modeling these data would be to place the text of
the question in --TEST and the response to the question, a date represented in
ISO 8601 format, in --ORRES and --STRESC as long as these date results do
not contain the dates of medically significant events or interventions. Again,
use extreme caution when storing dates as the results of Findings. Remember,
in most cases, these dates should be timing variables associated with a record
in an Intervention or Events dataset.

Dates are generally used only as timing variables, ... but there may be
occasions when it may be preferable to model a date as a result (--ORRES) in
a Findings dataset. ... this situation may occasionally occur when a) a group of
questions (each of which has a date response) is asked and analyzed together;
or b) the Event(s) and Intervention(s) in question are not medically significant
(often the case when included in questionnaires). Consider the following cases:
Calculated due date, Date of last day on the job, Date of high school
graduation. One approach to modeling these data would be to place the text of
the question in --TEST and the response to the question, a date represented in
ISO 8601 format, in --ORRES and --STRESC as long as these date results do
not contain the dates of medically significant events or interventions. Again,
use extreme caution when storing dates as the results of Findings. Remember,
in most cases, these dates should be timing variables associated with a record
in an Intervention or Events dataset.

Within the context that defines uniqueness for a time point, there is likely to be
a one-to-one relationship between most values of --TPT and --ELTM. However,
since --ELTM can only be populated with ISO 8601 periods of time (as
described in Section 4.1.4.3, Intervals of Time and Use of Duration for --DUR
Variables), --ELTM may not be populated for all time points. For example,
--ELTM is likely to be null for time points described by text such as 'pre-dose' or
'before breakfast.' When --ELTM is populated, if two subjects have records with
the same values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, then
these records may not have different values in --ELTM.
Within the context that defines uniqueness for a time point, there is likely to be
a one-to-one relationship between most values of --TPT and --ELTM. However,
since --ELTM can only be populated with ISO 8601 periods of time (as
described in Section 4.1.4.3, Intervals of Time and Use of Duration for --DUR
Variables), --ELTM may not be populated for all time points. For example,
--ELTM is likely to be null for time points described by text such as 'pre-dose' or
'before breakfast.' When --ELTM is populated, if two subjects have records with
the same values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, then
these records may not have different values in --ELTM.

The trial arms table describes each planned arm in the trial.
ETCD (the companion to ELEMENT) is limited to 8 characters
ETCD (the companion to ELEMENT) is limited to 8 characters
Number that gives the order of the Element within the Arm.
Number that gives the order of the Element within the Arm.
TAETORD is an integer.
TAETORD is an integer.
If an Element does not end with a decision that could lead to a shortened path
within the Arm, then TATRANS will be blank.
If an Element does not end with a decision that could lead to a shortened path
within the Arm, then TATRANS will be blank.
... values of EPOCH must be different for different epochs.
... values of EPOCH must be different for different epochs.
TABRANCH describes the outcome of a branch decision point in the trial
design for subjects in the Arm
TABRANCH describes the outcome of a branch decision point in the trial
design for subjects in the Arm
If the trial design allows a subject to transition to an Element other than the
next Element in sequence, then the conditions for transitioning to those other
Elements, and the alternative Element sequences, are specified in this rule
(e.g., Responders go to washout).
If the trial design allows a subject to transition to an Element other than the
next Element in sequence, then the conditions for transitioning to those other
Elements, and the alternative Element sequences, are specified in this rule
(e.g., Responders go to washout).
If inclusion/exclusion criteria were amended during the trial, then each
complete set of criteria must be included in the TI domain. TIVERS is used to
distinguish between the versions.
If inclusion/exclusion criteria were amended during the trial, then each
complete set of criteria must be included in the TI domain. TIVERS is used to
distinguish between the versions.
The number of this version of the Inclusion/Exclusion criteria. May be omitted if
there is only one version.
The number of this version of the Inclusion/Exclusion criteria. May be omitted if
there is only one version.
If inclusion/exclusion criteria were amended during the trial, then each
complete set of criteria must be included in the TI domain. TIVERS is used to
distinguish between the versions.
If inclusion/exclusion criteria were amended during the trial, then each
complete set of criteria must be included in the TI domain. TIVERS is used to
distinguish between the versions.
Specification[The number of this version of the Inclusion/Exclusion criteria. May
be omitted if there is only one version.]|Assumption 3[Individual criteria do not
have versions. If a criterion changes, it should be treated as a new criterion,
with a new value for IETESTCD.]
Specification[The number of this version of the Inclusion/Exclusion criteria. May
be omitted if there is only one version.]|Assumption 3[Individual criteria do not
have versions. If a criterion changes, it should be treated as a new criterion,
with a new value for IETESTCD.]
TSPARMCD (the companion to TSPARM) is limited to 8 characters and does
not have special character restrictions.
TSPARMCD (the companion to TSPARM) is limited to 8 characters and does
not have special character restrictions.
The value in TSPARM cannot be longer than 40 characters.
The value in TSPARM cannot be longer than 40 characters.
TSVAL can only be null when TSVALNF is populated.
TSVAL can only be null when TSVALNF is populated.
Null flavor for the value of TSPARM, to be populated if and only if TSVAL =
null.
Null flavor for the value of TSPARM, to be populated if and only if TSVAL =
null.
Text over 200 characters can be added to additional columns TSVAL1-
TSVALn.
Text over 200 characters can be added to additional columns TSVAL1-
TSVALn.
Text over 200 characters can be added to additional columns TSVAL1-
TSVALn.
Text over 200 characters can be added to additional columns TSVAL1-
TSVALn.
This is the code of the term in TSVAL.
This is the code of the term in TSVAL.
The version number of the Reference Terminology, if applicable.
The version number of the Reference Terminology, if applicable.
The version number of the Reference Terminology, if applicable.
The version number of the Reference Terminology, if applicable.
TSSEQ has a different value for each record for the same parameter.
TSSEQ has a different value for each record for the same parameter.

Further information about the parameters is included below in Table 1. TSVAL

IG v3.2[7.4][Assumption 3][Further information about the parameters is

IG v3.3[7.4.2][Assumption 3][Further information about the parameters is

IG v3.2[7.4][Assumption 3][Further information about the parameters is

IG v3.3[7.4.2][Assumption 3][Further information about the parameters is

included Appendix C1, Trial Summary Codes. TSVAL may have controlled
terminology depending on the value of TSPARMCD. Conditions for including
parameters are included in Appendix C1, Trial Summary Codes.]|IG
v3.3[Appendix C1][If the study population is healthy subjects (i.e., healthy
subjects flag is Y), this parameter is not expected. If the healthy subject flag is
N, then this parameter would contain the diagnosis/medical problem of the
study population. [Validation rule; IF healthy volunteers = N then TDIGRP must
be present and not null]
IG v3.2[7.4][Assumption 3][Further information about the parameters is
included below in Table 1. TSVAL may have controlled terminology depending
on the value of TSPARMCD.]|IG v3.2[Appendix C1][Required when ADDON
equals "Y"]
IG v3.3[7.4.2][Assumption 3][Further information about the parameters is
included Appendix C1, Trial Summary Codes. TSVAL may have controlled
terminology depending on the value of TSPARMCD. Conditions for including
parameters are included in Appendix C1, Trial Summary Codes.]|IG
v3.3[Appendix C1][Required when ADDON equals "Y"]
IG v3.3[7.4.2][Assumption 3][Further information about the parameters is
included below in Table 1. TSVAL may have controlled terminology depending
on the value of TSPARMCD]|IG v3.3[Appendix C1][If study type is
INTERVENTIONAL" this parameter is required]
IG v3.3[7.4.2][Assumption 3][Further information about the parameters is
included Appendix C1, Trial Summary Codes. TSVAL may have controlled
terminology depending on the value of TSPARMCD. Conditions for including
parameters are included in Appendix C1, Trial Summary Codes.]|IG
v3.3[Appendix C1][If study type is INTERVENTIONAL" this parameter is
required]
IG v3.3[7.4.2][Assumption 3][Further information about the parameters is
included below in Table 1. TSVAL may have controlled terminology depending
on the value of TSPARMCD]|IG v3.3[Appendix C1][If study type is
INTERVENTIONAL" this parameter is required]
IG v3.3[7.4.2][Assumption 3][Further information about the parameters is
included Appendix C1, Trial Summary Codes. TSVAL may have controlled
terminology depending on the value of TSPARMCD. Conditions for including
parameters are included in Appendix C1, Trial Summary Codes.]|IG
v3.3[Appendix C1][If study type is INTERVENTIONAL" this parameter is
required]
IG v3.3[7.4.2][Assumption 3][Further information about the parameters is
included below in Table 1. TSVAL may have controlled terminology depending
on the value of TSPARMCD]|IG v3.3[Appendix C1][If study type is
"INTERVENTIONAL" this parameter is required]
IG v3.3[7.4.2][Assumption 3][Further information about the parameters is
included Appendix C1, Trial Summary Codes. TSVAL may have controlled
terminology depending on the value of TSPARMCD. Conditions for including
parameters are included in Appendix C1, Trial Summary Codes.]|IG
v3.3[Appendix C1][If study type is "INTERVENTIONAL" this parameter is
required]
IG v3.3[7.4.2][Assumption 3][Further information about the parameters is
included below in Table 1. TSVAL may have controlled terminology depending
on the value of TSPARMCD]|IG v3.3[Appendix C1][If study type is
"INTERVENTIONAL" and if Intervention Type is one for which pharmacological
class is applicable this parameter is required.]

IG v3.3[7.4.2][Assumption 3][Further information about the parameters is

included Appendix C1, Trial Summary Codes. TSVAL may have controlled
terminology depending on the value of TSPARMCD. Conditions for including
parameters are included in Appendix C1, Trial Summary Codes.]|IG
v3.3[Appendix C1][If study type is "INTERVENTIONAL" and if Intervention
Type is one for which pharmacological class is applicable this parameter is
required.]
IG v3.2[7.4][Assumption 3][Further information about the parameters is
included below in Table 1. TSVAL may have controlled terminology depending
on the value of TSPARMCD]|IG v3.2[Appendix C1][Required only when there
is only one investigational treatment. The value is always a number between 0
and 1. There are cases where the ratio is 1 (e.g., crossover study or open label
study where all subjects are exposed to investigational therapy).]

IG v3.3[7.4.2][Assumption 3][Further information about the parameters is

included Appendix C1, Trial Summary Codes. TSVAL may have controlled
terminology depending on the value of TSPARMCD. Conditions for including
parameters are included in Appendix C1, Trial Summary Codes.]|IG
v3.3[Appendix C1][Required only when there is only one investigational
treatment. The value is always a number between 0 and 1. There are cases
where the ratio is 1 (e.g., crossover study or open label study where all
subjects are exposed to investigational therapy).]
|IG v3.2[Appendix C1][Further information about the parameters is included
below in Table 1. TSVAL may have controlled terminology depending on the
value of TSPARMCD]|IG v3.2[Appendix C1][Required only when there is only
one investigational treatment. The value is always a number between 0 and 1.
There are cases where the ratio is 1 (e.g., crossover study or open label study
where all subjects are exposed to investigational therapy).]

IG v3.3[7.4.2][Assumption 3][Further information about the parameters is

included Appendix C1, Trial Summary Codes. TSVAL may have controlled
terminology depending on the value of TSPARMCD. Conditions for including
parameters are included in Appendix C1, Trial Summary Codes.]|IG
v3.3[Appendix C1][Required only when there is only one investigational
treatment. The value is always a number between 0 and 1. There are cases
where the ratio is 1 (e.g., crossover study or open label study where all
subjects are exposed to investigational therapy).]

Further information about the parameters is included below in Table 1. TSVAL

may have controlled terminology depending on the value of TSPARMCD
Further information about the parameters is included Appendix C1, Trial
Summary Codes. TSVAL may have controlled terminology depending on the
value of TSPARMCD. Conditions for including parameters are included in
Appendix C1, Trial Summary Codes.
The version number of the Reference Terminology, if applicable.
The version number of the Reference Terminology, if applicable.
The version number of the Reference Terminology, if applicable.
The version number of the Reference Terminology, if applicable.
While it would be possible to allow a value such as NONE or UNBOUNDED to
be entered in TSVAL, validation programs would then have to recognize this
special term as an exception to the expected data format. Therefore, it was
decided that a separate null flavor variable that uses the ISO 21090 null flavor
terminology would be a better solution.
While it would be possible to allow a value such as NONE or UNBOUNDED to
be entered in TSVAL, validation programs would then have to recognize this
special term as an exception to the expected data format. Therefore, it was
decided that a separate null flavor variable that uses the ISO 21090 null flavor
terminology would be a better solution.
Further information about the parameters is included below in Table 1. TSVAL
may have controlled terminology depending on the value of TSPARMCD.
Conditions for including parameters are included in Table 1.
Further information about the parameters is included Appendix C1, Trial
Summary Codes. TSVAL may have controlled terminology depending on the
value of TSPARMCD. Conditions for including parameters are included in
Appendix C1, Trial Summary Codes.
2. If the timing of Visits for a trial does not depend on which ARM a subject is
in, then ARMCD should be null.
2. If the timing of Visits for a trial does not depend on which ARM a subject is
in, then ARMCD should be null.

1. Name given to an Arm or Treatment Group. 2. If the timing of Visits for a trial
does not depend on which Arm a subject is in, then Arm should be left blank.
1. Name given to an Arm or Treatment Group. 2. If the timing of Visits for a trial
does not depend on which Arm a subject is in, then Arm should be left blank.
If the timing of Visits for a trial does not depend on which ARM a subject is in,
then ARMCD should be null.
If the timing of Visits for a trial does not depend on which ARM a subject is in,
then ARMCD should be null.
If the timing of Visits for a trial does not depend on which Arm a subject is in,
then Arm should be left blank.
If the timing of Visits for a trial does not depend on which Arm a subject is in,
then Arm should be left blank.
ARMCD is limited to 20 characters and does not have special character
restrictions.
ARMCD is limited to 20 characters and does not have special character
restrictions.
Protocol-defined description of clinical encounter.
Protocol-defined description of clinical encounter.
The TR domain does not include anatomical location information on each
measurement record because this would be a duplication of information
already represented in TU. This duplication of data was a deciding factor in
multi-domain approach to representing this data.
The TR domain does not include anatomical location information on each
measurement record because this would be a duplication of information
already represented in TU. This duplication of data was a deciding factor in
multi-domain approach to representing this data.
The TR domain does not include anatomical location information on each
measurement record because this would be a duplication of information
already represented in TU. This duplication of data was a deciding factor in
multi-domain approach to representing this data.
The TR domain does not include anatomical location information on each
measurement record because this would be a duplication of information
already represented in TU. This duplication of data was a deciding factor in
multi-domain approach to representing this data.
The TR domain does not include anatomical location information on each
measurement record because this would be a duplication of information
already represented in TU. This duplication of data was a deciding factor in
multi-domain approach to representing this data.
The TR domain does not include anatomical location information on each
measurement record because this would be a duplication of information
already represented in TU. This duplication of data was a deciding factor in
multi-domain approach to representing this data.
The TR domain does not include anatomical location information on each
measurement record because this would be a duplication of information
already represented in TU. This duplication of data was a deciding factor in
multi-domain approach to representing this data.
The TR domain does not include anatomical location information on each
measurement record because this would be a duplication of information
already represented in TU. This duplication of data was a deciding factor in
multi-domain approach to representing this data.

Using SDTM-specified variable labels for all standard domains

The following Qualifiers would not be used in AE: --OCCUR, --STAT, and--
REASND. They are the only Qualifiers from the SDTM Events Class not in the
AE domain. They are not permitted because the AE domain contains only
records for adverse events that actually occurred.
The following Qualifiers would not be used in AE: --OCCUR, --STAT, and--
REASND. They are the only Qualifiers from the SDTM Events Class not in the
AE domain. They are not permitted because the AE domain contains only
records for adverse events that actually occurred.
TSPARMCD (the companion to TSPARM)
TSPARMCD (the companion to TSPARM)

Each domain dataset is distinguished by a unique, two-character code

Each domain dataset is distinguished by a unique, two-character code
Each domain dataset is distinguished by a unique, two-character code
The Variable Name (limited to 8 characters for compatibility with the SAS
Transport format)
In some cases, the standard variable name will be shortened to meet the 8-
character variable name requirement...
A descriptive Variable Label, using up to 40 characters, which should be
unique for each variable in the dataset

Variable descriptive names (labels), up to 40 characters, should be provided as

data variable labels for all variables, including Supplemental Qualifier variables.
The following standard domains, listed in alphabetical order by Domain Code,
with their respective domain codes have been defined or referenced by the
CDISC SDS Team in this document. Note that other domain models may be
posted separately for comment after this publication. See list in 2.5
A custom domain may only be created if the data are different in nature and do
not fit into an existing published domain.
STUDYID, DOMAIN, USUBJID (or POOLID), and --SEQ are required in all
domains based on one of the three general observation classes.
The SDTM allows for the inclusion of the sponsors non-SDTM variables using
the Supplemental Qualifiers special-purpose dataset structure, described in
Section 8: 8.4, Relating Non-Standard Variables Values To A Parent Domain.
IG v3.3[2.5][The SDTM allows for the inclusion of a sponsor's non-SDTM
variables using the Supplemental Qualifiers special purpose dataset structure,
described in Section 8.4, Relating Non-Standard Variables Values to a Parent
Domain.]|Model v1.7[2.1][New sponsor-defined variables must not be added,
and existing variables must not be renamed or modified for novel usage.]
IG v3.2[2.6][The domain pair uses DOMAIN as an Identifier to group parent
records (e.g., MB) from child records (e.g., MS) and enables a dataset-level
relationship to be described in RELREC.]|IG v3.2[6.3][PP][Pharmacokinetic
parameters derived from pharmacokinetic concentration-time (PC) data.]
IG v3.3[2.6]|IG v3.3[6.3.11.2][The domain pair uses DOMAIN as an Identifier to
group parent records (e.g., MB) from child records (e.g., MS) and enables a
dataset-level relationship to be described in RELREC.]|IG v3.3[6.3.11.2][A
findings domain that contains pharmacokinetic parameters derived from
pharmacokinetic concentration-time (PC) data.]
Include the Topic variable from the identified general observation class (e.g.,
--TESTCD for Findings)
Include the Topic variable from the identified general observation class (e.g.,
--TESTCD for Findings)
This section describes the overall process for creating a custom domain, which
must be based on one of the three SDTM general observation classes.
This section describes the overall process for creating a custom domain, which
must be based on one of the three SDTM general observation classes.
TESTRL should be expressed without referring to Arm. If the Element appears
in more than one Arm in the Trial Arms dataset; then the Element description
(ELEMENT) must not refer to any Arms.
TESTRL should be expressed without referring to Arm. If the Element appears
in more than one Arm in the Trial Arms dataset; then the Element description
(ELEMENT) must not refer to any Arms.
TESTRL should be expressed without referring to Epoch. If the Element
appears in more than one Epoch in the Trial Arms dataset; then the Element
description (ELEMENT) must not refer to any Epochs.
TESTRL should be expressed without referring to Epoch. If the Element
appears in more than one Epoch in the Trial Arms dataset; then the Element
description (ELEMENT) must not refer to any Epochs.
The Trial Arms dataset; not the Trial Elements dataset; describes where the
subject moves next; so TEENRL must be expressed without referring to Arm.
The Trial Arms dataset; not the Trial Elements dataset; describes where the
subject moves next; so TEENRL must be expressed without referring to Arm.
Specification[Expresses rule for ending Element. Either TEENRL or TEDUR
must be present for each Element.]|Assumption 15[Note that Elements that
have different start and end rules are different Elements and must have
different values of ELEMENT and ETCD.]
Note that Elements that have different start and end rules are different
Elements and must have different values of ELEMENT and ETCD.
Specification[Either TEENRL or TEDUR must be present for each Element.]|
Assumption 12[At least one of TEENRL or TEDUR must be populated. Both
may be populated.]
Specification[Either TEENRL or TEDUR must be present for each Element.]|
Assumption 12[At least one of TEENRL or TEDUR must be populated. Both
may be populated.]
Specification[Either TEENRL or TEDUR must be present for each Element.]|
Assumption 12[At least one of TEENRL or TEDUR must be populated. Both
may be populated.]
Specification[Either TEENRL or TEDUR must be present for each Element.]|
Assumption 12[At least one of TEENRL or TEDUR must be populated. Both
may be populated.]
Variables for the three general observation classes must be ordered with
Identifiers first; followed by the Topic; Qualifier; and Timing variables. Within
each role; variables must be ordered as shown in SDTM: Tables 2.2.1; 2.2.2;
2.2.3; 2.2.3.1; 2.2.4; and 2.2.5
Variables for the three general observation classes must be ordered with
Identifiers first; followed by the Topic; Qualifier; and Timing variables. Within
each role; variables must be ordered as shown in SDTM: Tables 2.2.1; 2.2.2;
2.2.3; 2.2.3.1; 2.2.4; and 2.2.5
Split dataset names can be up to four characters in length. For example; if
splitting by '--CAT; then dataset names would be the domain name plus up to
two additional characters (e.g., QS36 for SF-36). If splitting Findings About by
parent domain; then the dataset name would be the domain name plus the
two-character domain code describing the parent domain code (e.g., FACM).
The four-character dataset-name limitation allows the use of a Supplemental
Qualifier dataset associated with the split dataset.

Split dataset names can be up to four characters in length. For example; if

splitting by '--CAT; then dataset names would be the domain name plus up to
two additional characters (e.g., QS36 for SF-36). If splitting Findings About by
parent domain; then the dataset name would be the domain name plus the
two-character domain code describing the parent domain code (e.g., FACM).
The four-character dataset-name limitation allows the use of a Supplemental
Qualifier dataset associated with the split dataset.
Supplemental Qualifier datasets for split domains would also be split. The
nomenclature would include the additional one-to-two characters used to
identify the split dataset (e.g., SUPPQS36; SUPPFACM). The value of
RDOMAIN in the SUPP'-- datasets would be the two-character domain code
(e.g., QS; FA).
Supplemental Qualifier datasets for split domains would also be split. The
nomenclature would include the additional one-to-two characters used to
identify the split dataset (e.g., SUPPQS36; SUPPFACM). The value of
RDOMAIN in the SUPP'-- datasets would be the two-character domain code
(e.g., QS; FA).
Values for --CAT and --SCAT should not be redundant with the domain name
or dictionary classification provided by --DECOD and --BODSYS.
Values for --CAT and --SCAT should not be redundant with the domain name
or dictionary classification provided by --DECOD and --BODSYS.
Values for --CAT and --SCAT should not be redundant with the domain name
or dictionary classification provided by --DECOD and --BODSYS.
Values for --CAT and --SCAT should not be redundant with the domain name
or dictionary classification provided by --DECOD and --BODSYS.
Values for --CAT and --SCAT should not be redundant with the domain name
or dictionary classification provided by --DECOD and --BODSYS.
Values for --CAT and --SCAT should not be redundant with the domain name
or dictionary classification provided by --DECOD and --BODSYS.
Values for --CAT and --SCAT should not be redundant with the domain name
or dictionary classification provided by --DECOD and --BODSYS.
Values for --CAT and --SCAT should not be redundant with the domain name
or dictionary classification provided by --DECOD and --BODSYS.
Values for --CAT and --SCAT should not be redundant with the domain name
or dictionary classification provided by --DECOD and --BODSYS.
Values for --CAT and --SCAT should not be redundant with the domain name
or dictionary classification provided by --DECOD and --BODSYS.
Findings: 'Other; Specify' for tests may be handled similarly to Interventions.
--TESTCD and --TEST should be populated with the code and description of
the test found in the specified text. If specific tests are not prespecified on the
CRF and the investigator has the option of writing free text for tests; then the
name of the test would have to be coded to ensure that all --TESTCD and
--TEST values are controlled terminology and are not free text.
Findings: "Other; Specify" for tests may be handled similarly to Interventions.
--TESTCD and --TEST should be populated with the code and description of
the test found in the specified text. If specific tests are not prespecified on the
CRF and the investigator has the option of writing in tests; then the name of the
test would have to be coded to ensure that all --TESTCD and --TEST values
are consistent with the test controlled terminology.
Interventions: If a list of specific treatments is provided along with 'Other;
Specify'; --TRT should be populated with the name of the treatment found in
the specified text.
Interventions: If a list of specific treatments is provided along with 'Other;
Specify'; --TRT should be populated with the name of the treatment found in
the specified text.
Events: 'Other; Specify' for Events may be handled similarly to Interventions.
--TERM should be populated with the description of the event found in the
specified text and --PRESP could be used to distinguish between pre-specified
and free text responses.
Events: "Other; Specify" for Events may be handled similarly to Interventions.
--TERM should be populated with the description of the event found in the
specified text and --PRESP could be used to distinguish between prespecified
and free text responses.
If multiple values are reported for a topic variable (i.e.; --TRT in an
Interventions general-observation-class dataset or --TERM in an Events
general-observation-class dataset); it is assumed that the sponsor will split the
values into multiple records or otherwise resolve the multiplicity as per the
sponsor's standard data management procedures.
If multiple values are reported for a topic variable (i.e.; --TRT in an
Interventions general-observation-class dataset or --TERM in an Events
general-observation-class dataset); it is assumed that the sponsor will split the
values into multiple records or otherwise resolve the multiplicity as per the
sponsor's standard data management procedures.
If multiple values are reported for a topic variable (i.e.; --TRT in an
Interventions general-observation-class dataset or --TERM in an Events
general-observation-class dataset); it is assumed that the sponsor will split the
values into multiple records or otherwise resolve the multiplicity as per the
sponsor's standard data management procedures.
If multiple values are reported for a topic variable (i.e.; --TRT in an
Interventions general-observation-class dataset or --TERM in an Events
general-observation-class dataset); it is assumed that the sponsor will split the
values into multiple records or otherwise resolve the multiplicity as per the
sponsor's standard data management procedures.
If multiple values are reported for a topic variable (i.e.; --TRT in an
Interventions general-observation-class dataset or --TERM in an Events
general-observation-class dataset); it is assumed that the sponsor will split the
values into multiple records or otherwise resolve the multiplicity as per the
sponsor's standard data management procedures.
If multiple values are reported for a topic variable (i.e.; --TRT in an
Interventions general-observation-class dataset or --TERM in an Events
general-observation-class dataset); it is assumed that the sponsor will split the
values into multiple records or otherwise resolve the multiplicity as per the
sponsor's standard data management procedures.
Multiple Values for a Findings Result Variable. If multiple result values (--
ORRES) are reported for a test in a Findings class dataset; multiple records
should be submitted for that --TESTCD. Example: - EGTESTCD=RHYRATE;
EGTEST=Rhythm and Rate; EGORRES=ATRIAL FIBRILLATION. -
EGTESTCD=RHYRATE; EGTEST=Rhythm and Rate; EGORRES=ATRIAL
FLUTTER
If multiple result values (--ORRES) are reported for a test in a Findings class
dataset; multiple records should be submitted for that --TESTCD. When a
finding can have multiple results; the key structure for the findings dataset must
be adequate to distinguish between the multiple results. See Section 4.1.9
Assigning Natural Keys in the Metadata.
The --ORRES variable contains the result of the measurement or finding as
originally received or collected. --ORRES is an expected variable and should
always be populated; with two exceptions: When --STAT = 'NOT DONE'.
--ORRES should generally not be populated for derived records.
The --ORRES variable contains the result of the measurement or finding as
originally received or collected. --ORRES is an expected variable and should
always be populated; with two exceptions: When --STAT = 'NOT DONE'.
--ORRES should generally not be populated for derived records.

The philosophy applied to determine which variable names use a prefix was
that all variable names are prefixed with the Domain Identifier in which they
originate except the following: a. Required Identifiers (STUDYID; DOMAIN;
USUBJID). b. Commonly used grouping and merge Keys (VISIT; VISITNUM;
VISITDY); and many of the variables in trial design (such as ELEMENT and
ARM). c. All Demographics domain (DM) variables other than DMDTC and
DMDY. d. All variables in RELREC and SUPPQUAL; and some variables in
Comments and Trial Design datasets.
The following variables are exceptions to the philosophy that all variable names
are prefixed with the Domain Identifier: - Required Identifiers (STUDYID;
DOMAIN; USUBJID). -Commonly used grouping and merge Keys (e.g.,VISIT;
VISITNUM; VISITDY). -All Demographics domain (DM) variables other than
DMDTC and DMDY. -All variables in RELREC and SUPPQUAL; and some
variables in Comments and Trial Design datasets. Required Identifiers are not
prefixed because they are usually used as keys when merging/joining
observations. The --SEQ and the optional Identifiers --GRPID and --REFID are
prefixed because they may be used as keys when relating observations across
domains.
Values for --CAT and --SCAT should not be redundant with the domain name
or dictionary classification provided by --DECOD and --BODSYS.
Values for --CAT and --SCAT should not be redundant with the domain name
or dictionary classification provided by --DECOD and --BODSYS.
Using SDTM-specified standard variable names
Using SDTM-specified standard variable names
The following SDTM variables; defined for use in non-clinical studies (SEND);
must NEVER be used in the submission of SDTM-based data for human
clinical trials: --DTHREL (Findings) --EXCLFL (Findings) --REASEX (Findings)
--DETECT (Findings)
The following SDTM variables; defined for use in non-clinical studies (SEND);
must NEVER be used in the submission of SDTM-based data for human
clinical trials: --USCHFL (Interventions; Events; Findings) --DTHREL (Findings)
--EXCLFL (Findings) --REASEX (Findings) --IMPLBL (Findings) FETUSID
(Identifiers) --DETECT (Timing Variables) --NOMDY (Timing Variables)
--NOMLBL (Timing Variables)
The following SDTM variables; defined for use in non-clinical studies (SEND);
must NEVER be used in the submission of SDTM-based data for human
clinical trials: --DTHREL (Findings) --EXCLFL (Findings) --REASEX (Findings)
--DETECT (Findings)
The following SDTM variables; defined for use in non-clinical studies (SEND);
must NEVER be used in the submission of SDTM-based data for human
clinical trials: --USCHFL (Interventions; Events; Findings) --DTHREL (Findings)
--EXCLFL (Findings) --REASEX (Findings) --IMPLBL (Findings) FETUSID
(Identifiers) --DETECT (Timing Variables) --NOMDY (Timing Variables)
--NOMLBL (Timing Variables)
The following SDTM variables; defined for use in non-clinical studies (SEND);
must NEVER be used in the submission of SDTM-based data for human
clinical trials: --DTHREL (Findings) --EXCLFL (Findings) --REASEX (Findings)
--DETECT (Findings)
The following SDTM variables; defined for use in non-clinical studies (SEND);
must NEVER be used in the submission of SDTM-based data for human
clinical trials: --USCHFL (Interventions; Events; Findings) --DTHREL (Findings)
--EXCLFL (Findings) --REASEX (Findings) --IMPLBL (Findings) FETUSID
(Identifiers) --DETECT (Timing Variables) --NOMDY (Timing Variables)
--NOMLBL (Timing Variables)
The following SDTM variables; defined for use in non-clinical studies (SEND);
must NEVER be used in the submission of SDTM-based data for human
clinical trials: --DTHREL (Findings) --EXCLFL (Findings) --REASEX (Findings)
--DETECT (Findings)
The following SDTM variables; defined for use in non-clinical studies (SEND);
must NEVER be used in the submission of SDTM-based data for human
clinical trials: --USCHFL (Interventions; Events; Findings) --DTHREL (Findings)
--EXCLFL (Findings) --REASEX (Findings) --IMPLBL (Findings) FETUSID
(Identifiers) --DETECT (Timing Variables) --NOMDY (Timing Variables)
--NOMLBL (Timing Variables)
The following variables can be used for non-clinical studies (SEND) but must
NEVER be used in the Demographics domain for human clinical trials.
However; the use of these variables is currently being evaluated in Findings
general observation class domains being developed for use in the tabulations
of virology data: SPECIES (Demographics) STRAIN (Demographics)
SBSTRAIN (Demographics)
The following variables can be used for non-clinical studies (SEND) but must
NEVER be used in the Demographics domain for human clinical trials; where
all subjects are human. See Section 9.2; Non-host Organism Identifiers (OI);
for information about representing taxonomic information for non-host
organisms such as bacteria and viruses. SPECIES (Demographics) STRAIN
(Demographics) SBSTRAIN (Demographics)
The following variables can be used for non-clinical studies (SEND) but must
NEVER be used in the Demographics domain for human clinical trials.
However; the use of these variables is currently being evaluated in Findings
general observation class domains being developed for use in the tabulations
of virology data: - SPECIES (Demographics) - STRAIN (Demographics) -
SBSTRAIN (Demographics)
The following variables can be used for non-clinical studies (SEND) but must
NEVER be used in the Demographics domain for human clinical trials; where
all subjects are human. See Section 9.2; Non-host Organism Identifiers (OI);
for information about representing taxonomic information for non-host
organisms such as bacteria and viruses. SPECIES (Demographics) STRAIN
(Demographics) SBSTRAIN (Demographics)
The following variables can be used for non-clinical studies (SEND) but must
NEVER be used in the Demographics domain for human clinical trials.
However; the use of these variables is currently being evaluated in Findings
general observation class domains being developed for use in the tabulations
of virology data: SPECIES (Demographics) STRAIN (Demographics)
SBSTRAIN (Demographics)
The following variables can be used for non-clinical studies (SEND) but must
NEVER be used in the Demographics domain for human clinical trials; where
all subjects are human. See Section 9.2; Non-host Organism Identifiers (OI);
for information about representing taxonomic information for non-host
organisms such as bacteria and viruses. SPECIES (Demographics) STRAIN
(Demographics) SBSTRAIN (Demographics)
Use title case for all labels (title case means to capitalize the first letter of every
word except for articles; prepositions; and conjunctions).
Use title case for all labels (title case means to capitalize the first letter of every
word except for articles; prepositions; and conjunctions).
Either USUBJID or POOLID must be populated.
Either USUBJID or POOLID must be populated.
Either USUBJID or POOLID must be populated.
Either USUBJID or POOLID must be populated.
Identifier used to identify a related subject or pool of subjects. RSUBJID will be
populated with either the USUBJID of the related subject or the POOLID of the
related pool.
Identifier used to identify a related subject or pool of subjects. RSUBJID will be
populated with either the USUBJID of the related subject or the POOLID of the
related pool.
Identifier used to identify a related subject or pool of subjects. RSUBJID will be
populated with either the USUBJID of the related subject or the POOLID of the
related pool.
Identifier used to identify a related subject or pool of subjects. RSUBJID will be
populated with either the USUBJID of the related subject or the POOLID of the
related pool.
Associated Persons (AP) are persons who can be associated with a study; a
particular study subject or a device used in the study.
Associated Persons (AP) are persons who can be associated with a study; a
particular study subject or a device used in the study.
Associated Persons (AP) are persons who can be associated with a study; a
particular study subject or a device used in the study.
Associated Persons (AP) are persons who can be associated with a study; a
particular study subject or a device used in the study.
Identifier for a related study subject or pool of study subjects. The subject(s)
may be human or animal. RSUBJID will be populated with the USUBJID of the
related subject or the POOLID of the related pool. RSUBJID will be null for data
about associated persons who are related to the study but not to any of the
study subjects.
Identifier for a related subject or pool of subjects. RSUBJID may be populated
with the USUBJID of the related subject or the POOLID of the related pool.
RSUBJID will be null for data about associated persons who are related to the
study but not to any study subjects
Each study must include one standardized set of observations in a specific
structure; this is the Demographics domain described in Table 2.2.6.
Each study must include one standardized set of observations in a specific
structure; this is the Demographics domain described in Table 2.2.6.

Domain Abbreviation of the parent record(s).

Identifying variable in the parent dataset that identifies the record(s) to which
the comment applies.
Identifying variable in the parent dataset that identifies the record(s) to which
the comment applies.

Value of identifying variable of the parent record(s).

IG v3.2[4.1.2.1][Values of --TESTCD must be limited to 8 characters; and
cannot start with a number; nor can they contain characters other than letters;
numbers; or underscores]|Model v1.4[3.3.1][The value in IETESTCD cannot be
longer than 8 characters; nor can it start with a number (e.g., '1TEST').
IETESTCD cannot contain characters other than letters; numbers; or
underscores.]
IG v3.3[7.4.1 ][Values of --TESTCD must be limited to 8 characters; and cannot
start with a number; nor can they contain characters other than letters;
numbers; or underscores]|Model v1.7[3.2.1][The value in IETESTCD cannot be
longer than 8 characters; nor can it start with a number (e.g., '1TEST').
IETESTCD cannot contain characters other than letters; numbers; or
underscores.]
There is a one-to-one correspondence between a domain dataset and it's
Supplemental Qualifier dataset by creating one SUPPQUAL for each domain
dataset. The single SUPPQUAL dataset option that was introduced in SDTMIG
v3.1.1 is now deprecated. The set of Supplemental Qualifiers for each domain
is included in a separate dataset with the name SUPP-- where '--' denotes the
source domain which the supplemental Qualifiers relate back to.
There is a one-to-one correspondence between a domain dataset and its
Supplemental Qualifier dataset. The single SUPPQUAL dataset option that
was introduced in SDTMIG v3.1 was deprecated. The set of Supplemental
Qualifiers for each domain is included in a separate dataset with the name
SUPP-- where "--" denotes the source domain which the Supplemental
Qualifiers relate back to.
Two-character abbreviation for the domain of the parent record(s).
2-character abbreviation for the domain of the parent record(s).

IG v3.2[7.3][A reference to the date variable name that provides the start point
from which the planned disease assessment schedule is measured. This must
be referenced from the ADaM ADSL dataset e.g. ANCH1DT. Note:
TDANCVAR is to contain the name of a reference date variable name.]|Model
v1.4[3.5.1][A reference to the date variable name that provides the start point
from which the planned disease assessment schedule is measured. This must
be referenced from the ADaM ADSL dataset e.g. ANCH1DT. Note:
TDANCVAR is to contain the name of a reference date variable name.]

IG v3.3[7.3.2][A reference to the date variable name that provides the start
point from which the planned disease assessment schedule is measured. This
must be referenced from the ADaM ADSL dataset (e.g., ANCH1DT). Note:
TDANCVAR is to contain the name of a reference date variable name.]|Model
v1.7[3.4.1][A reference to the date variable name that provides the start point
from which the planned disease assessment schedule is measured. This must
be referenced from the ADaM ADSL dataset (e.g., ANCH1DT). Note:
TDANCVAR is to contain the name of a reference date variable name.]

IG v3.2[7.3][A fixed offset from the date provided by the variable referenced in
TDANCVAR. This is used when the timing of planned cycles does not start on
the exact day referenced in the variable indicated in TDANCVAR. The value of
this variable will be either zero or a positive value and will be represented in
ISO 8601 character format.]|Model v1.4[3.5.1][A fixed offset from the date
provided by the variable referenced in TDANCVAR. This is used when the
timing of planned cycles does not start on the exact day referenced in the
variable indicated in TDANCVAR. The value of this variable will be either zero
or a positive value and will be represented in ISO 8601 character format.]
IG v3.3[7.3][A fixed offset from the date provided by the variable referenced in
TDANCVAR. This is used when the timing of planned cycles does not start on
the exact day referenced in the variable indicated in TDANCVAR. The value of
this variable will be either zero or a positive value and will be represented in
ISO 8601 character format.]|Model v1.7[3.4.1][A fixed offset from the date
provided by the variable referenced in TDANCVAR. This is used when the
timing of planned cycles does not start on the exact day referenced in the
variable indicated in TDANCVAR. The value of this variable will be either zero
or a positive value and will be represented in ISO 8601 character format.]
MedDRA Lowest Level Term.
MedDRA Lowest Level Term.
MedDRA Lowest Level Term.
MedDRA Lowest Level Term.
Dictionary or sponsor-defined derived text description of the topic variable;
--TERM; or the modified topic variable (--MODIFY); if applicable. Equivalent to
the Preferred Term (PT in MedDRA).
Dictionary or sponsor-defined derived text description of the topic variable;
--TERM; or the modified topic variable (--MODIFY); if applicable. Equivalent to
the Preferred Term (PT in MedDRA).
MedDRA Preferred Term code.
MedDRA Preferred Term code.
MedDRA High Level Term from the primary path.
MedDRA High Level Term from the primary path.
MedDRA High Level Term code from the primary path.
MedDRA High Level Term code from the primary path.
MedDRA High Level Group Term from the primary path.
MedDRA High Level Group Term from the primary path.
MedDRA High Level Group Term code from the primary path.
MedDRA High Level Group Term code from the primary path.
Body system or system organ class assigned for analysis from a standard
hierarchy (e.g. MedDRA) associated with an event. Example:
GASTROINTESTINAL DISORDERS.
Body system or system organ class assigned for analysis from a standard
hierarchy (e.g. MedDRA) associated with an event. Example:
GASTROINTESTINAL DISORDERS.
MedDRA System Organ Class code corresponding to -BODSYS assigned for
analysis.
MedDRA System Organ Class code corresponding to -BODSYS assigned for
analysis.
Is this is a serious event? Valid values are 'Y' and 'N'.
Is this is a serious event? Valid values are 'Y' and 'N'.
Was the event associated with the development of cancer? Valid values are 'Y'
and 'N'.
Was the event associated with congenital anomaly or birth defect? Valid values
are 'Y' and 'N'.
Did the event result in persistent or significant disability/incapacity? Valid
values are 'Y' and 'N'.
Did the event result in death? Valid values are 'Y' and 'N'.
Did the event require or prolong hospitalization? Valid values are 'Y' and 'N'.
Did the event require or prolong hospitalization? Valid values are 'Y' and 'N'.
Did the event occur with an overdose? Valid values are 'Y' and 'N'.
Do additional categories for seriousness apply? Valid values are 'Y' and 'N'.
Was another treatment given because of the occurrence of the event? Valid
values are 'Y' and 'N'.
Was another treatment given because of the occurrence of the event? Valid
values are "Y", "N", and null.

IG v3.2[6.3 LB][Contains the result value for all findings; copied or derived from
LBORRES in a standard format or standard units. LBSTRESC should store all
results or findings in character format; if results are numeric; they should also
be stored in numeric format in LBSTRESN. For example; if a test has results
'NONE'; 'NEG'; and 'NEGATIVE' in LBORRES and these results effectively
have the same meaning; they could be represented in standard format in
LBSTRESC as 'NEGATIVE'. For other examples; see general assumptions.]|
Model v1.4[2.2.3][Contains the result value for all findings; copied or derived
from --ORRES in a standard format or in standard units.]

IG v3.3[6.3.6][Contains the result value for all findings; copied or derived from
--ORRES in a standard format or in standard units.]|Model v1.7[2.2.3] Contains
the result value for all findings; copied or derived from LBORRES in a standard
format or standard units. LBSTRESC should store all results or findings in
character format; if results are numeric; they should also be stored in numeric
format in LBSTRESN. For example; if a test has results 'NONE'; 'NEG'; and
'NEGATIVE' in LBORRES and these results effectively have the same
meaning; they could be represented in standard format in LBSTRESC as
'NEGATIVE'. For other examples; see general assumptions.]

ICH E3: Section 10.1 indicates that 'the specific reason for discontinuation'
should be presented; and that summaries should be 'grouped by treatment and
by major reason.' The CDISC SDS Team interprets this guidance as requiring
one standardized disposition term (DSDECOD) per disposition event. If
multiple reasons are reported; the sponsor should identify a primary reason
and use that to populate DSTERM and DSDECOD. Additional reasons should
be submitted in SUPPDS.
Indicates the upper limit of quantitation for an assay. Units will be those used
for --STRESU.
Indicates the upper limit of quantitation for an assay. Units will be those used
for --STRESU.
Logical Observation Identifiers Names and Codes (LOINC) code for the topic
variable such as a lab test.
Logical Observation Identifiers Names and Codes (LOINC) code for the topic
variable such as a lab test.
Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention
is pre-specified on a CRF. Values should be 'Y' or null.][--OCCUR: Used to
record whether a pre-specified event occurred when information about the
occurrence of a specific event is solicited.][--STAT: Used to indicate when a
question about the occurrence of a pre-specified event was not answered.
Should be null or have a value of NOT DONE]|Model v1.4[2.2.2 (Events)][--
PRESP: Used to indicate whether the event describe by --TERM was pre-
specified on a CRF. Value is Y for pre-specified events; null for spontaneously
reported events.][--OCCUR: Used to record whether a pre-specified event
occurred when information about the occurrence of a specific event is
solicited.][--STAT: Used to indicate when a question about the occurrence of a
pre-specified event was not answered. Should be null or have a value of NOT
DONE]

Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention

is pre-specified on a CRF. Values should be 'Y' or null.][--OCCUR: Used to
record whether a pre-specified event occurred when information about the
occurrence of a specific event is solicited.][--STAT: Used to indicate when a
question about the occurrence of a pre-specified event was not answered.
Should be null or have a value of NOT DONE]|Model v1.7[2.2.2 (Events)][--
PRESP: Used to indicate whether the event describe by --TERM was pre-
specified on a CRF. Value is Y for pre-specified events; null for spontaneously
reported events.][--OCCUR: Used to record whether a pre-specified event
occurred when information about the occurrence of a specific event is
solicited.][--STAT: Used to indicate when a question about the occurrence of a
pre-specified event was not answered. Should be null or have a value of NOT
DONE]
The length of --TEST is normally limited to 40 characters to conform to the
limitations of the SAS V5 Transport format currently used for submission
datasets. IETEST values in IE and TI are exceptions to the above 40-character
rule and are limited to 200 characters since they are not expected to be
transformed to a column labels.

Sponsors may have test descriptions (--TEST) longer than 40 characters in

their operational database. Since the --TEST variable is meant to serve as a
label for a --TESTCD when a Findings dataset is transposed to a more
horizontal format; the length of --TEST is limited to 40 characters (except as
noted below) to conform to the limitations of the SAS v5 Transport format
currently used for submission datasets. IETEST values in IE and TI are
exceptions to the above 40-character rule and are limited to 200 characters
since they are not expected to be transformed to a column labels.
The EX domain is required for all studies that include protocol-specified study
treatment.
The EX domain is required for all studies that include protocol-specified study
treatment.
In the event that no records are present in a dataset (e.g., a small PK study
where no subjects took concomitant medications); the empty dataset should
not be submitted and should not be described in the define.xml document.
In the event that no records are present in a dataset (e.g., a small PK study
where no subjects took concomitant medications); the empty dataset should
not be submitted and should not be described in the Define-XML document.
All records with the same STUDYID value are a group of records that describe
that study
All records with the same STUDYID value are a group of records that describe
that study
One record per subject per actual visit.
IG v3.3[5.5 SV][One record per subject per actual visit.]|IG v3.3[7.3.1.1 TV][TV
Issues 4][Some data collection is contingent on the occurrence of a "trigger"
event; or disease milestone (see Section 7.3.3 Trial Disease Milestones).
When such planned data collection involves an additional clinic visit; a
"contingent" Visit may be included in the trial visits table;]
One record per IDVAR, IDVARVAL, and QNAM value per subject
The combined set of values for the first six columns (STUDYID-QNAM) should
be unique for every record. That is; there should not be multiple records in a
SUPP-- dataset for the same QNAM value; as it relates to IDVAR/IDVARVAL
for a USUBJID in a domain.
The Disposition dataset provides an accounting for all subjects who entered
the study and may include protocol milestones; such as randomization; as well
as the subject's completion status or reason for discontinuation for the entire
study or each phase or segment of the study; including screening and post-
treatment follow-up.
This code; which is stored in the SDTM variable named DOMAIN; is used in
four ways: as the dataset name; the value of the DOMAIN variable in that
dataset; as a prefix for most variable names in that dataset; and as a value in
the RDOMAIN variable in relationship tables.
Each domain dataset is distinguished by a unique; 2-character code that
should be used consistently throughout the submission. This code; which is
stored in the SDTM variable named DOMAIN; is used in 4 ways: as the dataset
name; as the value of the DOMAIN variable in that dataset; as a prefix for most
variable names in that dataset; and as a value in the RDOMAIN variable in
relationship tables.

The Subject Elements domain allows the submission of data on the timing of
the trial Elements a subject actually passed through in their participation in the
trial. Please read Section 7.2.2 - Experimental Design: Trial Elements (TE); on
the Trial Elements dataset and Section 7.2.1 - Experimental Design: Trial Arms
(TA); on the Trial Arms dataset; as these datasets define a trial's planned
Elements; and describe the planned sequences of lements for the Arms of the
trial.
The trial arms table describes each planned arm in the trial.
A trial design domain that contains each planned arm in the trial.
This is the long name or label associated with QNAM. The value in QLABEL
cannot be longer than 40 characters. This will often be the column label in the
sponsor's original dataset.
This is the long name or label associated with QNAM. The value in QLABEL
cannot be longer than 40 characters. This will often be the column label in the
sponsor's original dataset.
The value in QNAM cannot be longer than 8 characters; nor can it start with a
number (e.g., '1TEST'). QNAM cannot contain characters other than letters;
numbers; or underscores.
The value in QNAM cannot be longer than 8 characters; nor can it start with a
number (e.g., '1TEST'). QNAM cannot contain characters other than letters;
numbers; or underscores.
Number that gives the planned order of the Element within the Arm (see Trial
Arms; Section 3.2.2 ).
Number that gives the planned order of the Element within the Arm (see
Section 3.1.2; Trial Arms).

IG v3.2[8.2.1][Identifies the hierarchical level of the records in the relationship.

Values should be either ONE or MANY. Used only when identifying a
relationship between datasets (as described in Section 8.3).]IG v3.2[8.3.1]
[Since IDVAR identifies the keys that can be used to merge/join records
between the datasets; the root values (e.g., -- GRPID in the above example)
for IDVAR must be the same for both records with the same RELID. --SEQ
cannot be used because --SEQ only has meaning within a subject within a
dataset; not across datasets.]
IG v3.3[8.2.1][Identifies the hierarchical level of the records in the relationship.
Values should be either ONE or MANY. Used only when identifying a
relationship between datasets (as described in Section 8.3).]|IG v3.3[8.3.1]
[Since IDVAR identifies the keys that can be used to merge/join records
between the datasets; --SEQ cannot be used because --SEQ only has
meaning within a subject within a dataset; not across datasets.]
Identifies the start of the observation as being before; during; or after the
sponsor-defined reference period. The sponsor-defined reference period is a
continuous period of time defined by a discrete starting point and a discrete
ending point represented by RFSTDTC and RFENDTC in Demographics.
Identifies the start of the observation as being before; during; or after the
sponsor-defined reference period. The sponsor-defined reference period is a
continuous period of time defined by a discrete starting point and a discrete
ending point represented by RFSTDTC and RFENDTC in Demographics.
Identifies the end of the observation as being before; during or after the
sponsor-defined reference period. The sponsor-defined reference period is a
continuous period of time defined by a discrete starting point and a discrete
ending point represented by RFSTDTC and RFENDTC in Demographics.
Identifies the end of the observation as being before; during or after the
sponsor-defined reference period. The sponsor-defined reference period is a
continuous period of time defined by a discrete starting point and a discrete
ending point represented by RFSTDTC and RFENDTC in Demographics.
Used to indicate exam not done. Should be null if a result exists in LBORRES.
Used to indicate exam not done. Should be null if a result exists in LBORRES.
--TRTV:Vehicle for administration of treatment; such as a liquid in which the
treatment drug is dissolved. Example: SALINE. --VAMT: Amount of the
prepared product (treatment + vehicle) administered or given. Note: should not
be diluent amount alone. --VAMTU: Units for the prepared product (treatment +
vehicle). Examples: mL; mg.
--TRTV:Vehicle for administration of treatment; such as a liquid in which the
treatment drug is dissolved. Example: SALINE. --VAMT: Amount of the
prepared product (treatment + vehicle) administered or given. Note: should not
be diluent amount alone. --VAMTU: Units for the prepared product (treatment +
vehicle). Examples: mL; mg.
--STRESU: Standardized units used for --STRESC and --STRESN.
--STRESU:Standardized units used for --STRESC, --STRESN, --STREFC, and
--STREFN. Example: "mol/L".
--STRESU: Standardized units used for --STRESC and --STRESN.
--STRESU: Standardized units used for --STRESC, --STRESN, --STREFC, and
--STREFN. Example: "mol/L".
--STRESC: Contains the result value for all findings, copied or derived from
--ORRES in a standard format or in standard units. --RESCAT: used to
categorize the result of a finding.
--STRESC: Contains the result value for all findings, copied or derived from
--ORRES in a standard format or in standard units. --RESCAT: used to
categorize the result of a finding.
Description of toxicity quantified by --TOXGR such as NCI CTCAE Short
Name. Examples: HYPERCALCEMIA; HYPOCALCEMIA. Sponsor should
specify which scale and version is used in the Sponsor Comments column of
the Define-XML document.
Description of toxicity quantified by --TOXGR such as NCI CTCAE Short
Name. Examples: HYPERCALCEMIA; HYPOCALCEMIA. Sponsor should
specify which scale and version is used in the Sponsor Comments column of
the Define-XML document.
Used to define a further categorization of --CAT values.

2.2.1[Table 3.2.1: --SCAT][Used to define a further categorization of --CAT

values.]|2.2.2[Table 3.2.2: --SCAT][Used to define a further categorization of
--CAT values.]|2.2.3[Table 3.2.3: --SCAT][Used to define a further
categorization of --CAT values.]
When no data has been collected for an expected variable; however; a null
column must still be included in the dataset; and a comment must be included
in the define.xml to state that data was not collected.
When the study does not include the data item for an expected variable;
however; a null column must still be included in the dataset; and a comment
must be included in the Define-XML document to state that the study does not
include the data item.
Units associated with AGE or AGETXT.
Units associated with AGE or AGETXT.
Units associated with AGE or AGETXT.
Units associated with AGE or AGETXT.
Units associated with AGE or AGETXT.
Units associated with AGE or AGETXT.
A value of 'Y' indicates the subject died. Should be Y or null. Should be
populated even when the death date is unknown.
A value of "Y" indicates the subject died. Should be "Y" or null. Should be
populated even when the death date is unknown.
MedDRA primary System Organ Class associated with the event.
MedDRA primary System Organ Class associated with the event.
MedDRA primary System Organ Class code.
MedDRA primary System Organ Class code.