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SAS 9.2 CDISC Procedure - User's Guide

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SAS 9.2 CDISC Procedure - User's Guide

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®

SAS 9.2 CDISC Procedure

User’s Guide
The correct bibliographic citation for this manual is as follows: SAS Institute Inc. 2008.
SAS ® 9.2 CDISC Procedure: User’s Guide. Cary, NC: SAS Institute Inc.
SAS® 9.2 CDISC Procedure: User’s Guide
Copyright © 2008, SAS Institute Inc., Cary, NC, USA
ISBN 978-1-59994-324-4
All rights reserved. Produced in the United States of America.
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photocopying, or otherwise, without the prior written permission of the publisher, SAS
Institute Inc.
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terms established by the vendor at the time you acquire this publication.
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software and related documentation by the U.S. government is subject to the Agreement
with SAS Institute and the restrictions set forth in FAR 52.227-19 Commercial Computer
Software-Restricted Rights (June 1987).
SAS Institute Inc., SAS Campus Drive, Cary, North Carolina 27513.
1st electronic book, February 2008
2nd electronic book, May 2010
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respective companies.
Contents

What’s New v

Overview v

CDISC SDTM Validation Support v

Enhanced CDISC ODM Support v

PART 1 Concepts 1

Chapter 1 � Introduction to the CDISC Procedure 3

What Is CDISC? 3

What Is the CDISC Procedure? 3

Overview of PROC CDISC Syntax 4

Chapter 2 � Importing and Exporting a CDISC ODM XML Document 5

Introduction to CDISC ODM 5

CDISC ODM KeySet Members 6

Specifying CDISC ODM Metadata Attributes 9

Chapter 3 � Validating a CDISC SDTM SAS Data Set 11

Introduction to CDISC SDTM 11

Validating a CDISC SDTM SAS Data Set 11

CDISC Procedure Capabilities for Validating a CDISC SDTM SAS Data Set 11

PART 2 Usage 13

Chapter 4 � CDISC Procedure Examples for CDISC ODM 15

Example: Importing a CDISC ODM XML Document Using Default KeySet

Processing 16

Example: Importing a CDISC ODM XML Document Specifying KeySet Processing

Options 19

Example: Importing a CDISC ODM XML Document Using a Language Identiﬁer 21

Example: Importing a CDISC ODM XML Document with OrderNumber Attributes 27

Example: Exporting a CDISC ODM XML Document with Metadata Attributes in

Statement Syntax 28

Example: Exporting a CDISC ODM XML Document with Metadata Attributes in SAS

Data Sets 33

Example: Exporting a CDISC ODM XML Document with Required and Optional

Statements 38

Example: Describing a CDISC ODM SAS Data Set with the CONTENTS

Statement 42

Example: Listing a Directory with the DATASETS Statement 46

Chapter 5 � CDISC Procedure Examples for CDISC SDTM 49

Example: Validating CDISC SDTM Data in a SAS Data Set 49

Example: Validating CDISC SDTM Data in an Oracle Table 50

PART 3 Procedure Reference 51

Chapter 6 � CDISC Procedure for CDISC ODM 53

Overview: CDISC Procedure for CDISC ODM 53

Syntax: CDISC Procedure for CDISC ODM 53

Chapter 7 � CDISC Procedure for CDISC SDTM 75

Overview: CDISC Procedure for CDISC SDTM 75

Syntax: CDISC Procedure for CDISC SDTM 75

PART 4 Appendixes 79

Appendix 1 � Sample XML Document 81

Sample CDISC ODM XML Document 81

Appendix 2 � Recommended Reading 89

CDISC SDTM Validation Support

PROC CDISC performs data content validation on a SAS data set that conforms to
CDISC SDTM version 3.1. PROC CDISC validates the SAS data set against domains
that are provided by CDISC SDTM. See Chapter 3, “Validating a CDISC SDTM SAS
Data Set,” on page 11, and Chapter 7, “CDISC Procedure for CDISC SDTM,” on page 75.

Enhanced CDISC ODM Support

For a CDISC ODM XML document, PROC CDISC provides the following changes:
3 There is no longer an ODM normative document (ODM-ND) non-conformance
issue. The SignificantDigits attribute (decimal precision) in an ItemDef element
for a floating-point value (DataType=float) that is required by the ODM-ND is now
generated.
3 PROC CDISC behavior for handling SAS data set (ItemGroupDef element),
variable (ItemDef element), and format (CodeList element) names is controlled by
the new LONGNAMES= processing option. See “ODM Statement” on page 57. The
option determines the sources of captured SAS name parameters and controls the
maximum length of SAS names that is valid.
3 PROC CDISC produces a directory listing of the CDISC ODM XML document with
the DATASETS statement, and PROC CDISC describes the contents of a CDISC
ODM SAS data set with the CONTENTS statement. See “CONTENTS Statement”
on page 73 and “DATASETS Statement” on page 74.
vi What’s New

3 The PROC CDISC statement now includes the LANGUAGE= option to specify a
language identifier. See “PROC CDISC Statement for CDISC ODM” on page 55.
3 The ORDERNUMBER= processing option determines whether PROC CDISC
validates OrderNumber attributes when you import a CDISC ODM XML
document. See “ODM Statement” on page 57.
3 PROC CDISC behavior to determine the sources of captured SAS data set and
variable labels is controlled by the new USENAMEASLABEL= processing option.
See “ODM Statement” on page 57.
3 The CLINICALDATA statement now supports the INVESTIGATORREF= option to
determine whether to import the unique identifier for the investigator user, and
the SITEREF= option to determine whether to import the unique identifier for the
clinical data study location. See “CLINICALDATA Statement” on page 71.
1

1
P A R T

Concepts

Chapter 1. . . . . . . . . . Introduction to the CDISC Procedure 3

Chapter 2 . . . . . . . . . . Importing and Exporting a CDISC ODM XML Document 5

Chapter 3 . . . . . . . . . . Validating a CDISC SDTM SAS Data Set 11

CHAPTER

1
Introduction to the CDISC
Procedure

What Is CDISC? 3
What Is the CDISC Procedure? 3
Overview of PROC CDISC Syntax 4

What Is CDISC?
CDISC is an organization that develops industry standards. The standards support
the electronic acquisition, exchange, and archival of clinical trials data and metadata
for medical and biopharmaceutical product development. CDISC deﬁnes several data
models for the interoperability of clinical data exchange.
The mission of CDISC is to develop and support global, platform-independent data
standards that enable information system interoperability to improve medical research
and related areas of health care.
For more information about CDISC, see the Web site at www.cdisc.org.
Note: The CDISC mission statement above is cited from the CDISC Web site. In
addition, some explanations in the CDISC procedure documentation are from the
CDISC standards descriptions. �

What Is the CDISC Procedure?

The CDISC procedure provides functionality that is based on specific CDISC models.
The procedure currently supports the following CDISC models and functionality:
CDISC ODM PROC CDISC provides the ability to import and export XML
version 1.2 documents that conform to CDISC ODM version 1.2.
3 Importing is the process of reading an external XML document
as a SAS data set.
3 Exporting is the process of writing a SAS data set to an output
XML document that conforms to a CDISC model.
CDISC SDTM PROC CDISC performs data content validation on a SAS data set
version 3.1 that conforms to CDISC SDTM version 3.1. PROC CDISC validates
the SAS data set against domain definitions that are provided by
CDISC SDTM.
Note: A SAS data set is any file that is accessed by SAS, such as a SAS data file or
a file that points to data from other sources, such as a DBMS table that is accessed
with a SAS/ACCESS engine. �
4 Overview of PROC CDISC Syntax � Chapter 1

Overview of PROC CDISC Syntax

The syntax for PROC CDISC depends on the following:
3 The CDISC model determines the set of associated statements. That is, CDISC
ODM has a set of associated statements, and CDISC SDTM has a set of associated
statements.
3 For CDISC ODM, whether you want to import or export a ﬁle determines what
statements are required or optional. In addition, each statement supports both
required and optional syntax, depending on the process.

The following PROC CDISC code shows the syntax that is required to import an
XML document that conforms to CDISC ODM version 1.2:
proc cdisc model=odm read=xmlinp;
odm odmversion="1.2";
clinicaldata out=results.ae sasdatasetname="AE";
run;

The following PROC CDISC code shows the syntax that is required to validate a SAS
data set that conforms to CDISC SDTM version 3.1:

proc cdisc model=sdtm;

sdtm sdtmversion="3.1";
domaindata data=results.ae domain=ae catagory=events;
run;
5

CHAPTER

2
Importing and Exporting a CDISC
ODM XML Document

Introduction to CDISC ODM 5

What Is CDISC ODM? 5
CDISC ODM Basics 5
CDISC ODM KeySet Members 6
What Is a CDISC ODM KeySet? 6
Converting CDISC ODM KeySet Members 6
Processing CDISC ODM KeySet Members 8
Specifying CDISC ODM Metadata Attributes 9
Introduction to CDISC ODM Metadata Attributes 9
Specifying CDISC ODM Metadata Attributes When Importing 10
Specifying CDISC ODM Metadata Attributes When Exporting 10

Introduction to CDISC ODM

What Is CDISC ODM?

CDISC ODM is a vendor-neutral, platform-independent format. CDISC ODM
supports the electronic acquisition, exchange, and archival of clinical trials data for the
medical and biopharmaceutical industries.
PROC CDISC supports CDISC ODM version 1.2.

CDISC ODM Basics

CDISC ODM deﬁnes the following entities to represent clinical trials (study) data:

item describes an individual study item, such as a single blood pressure

reading.

item group describes a closely related set of study items that are usually
analyzed together.

form describes logically or temporally related information. Forms can

contain multiple item groups.

study event describes a data collection event such as a patient visit. A series of
forms might be collected as part of a study event. A study event is
associated with a speciﬁc patient in the study.
6 CDISC ODM KeySet Members � Chapter 2

CDISC ODM defines the following metadata to describe the types of study events,
forms, item groups, and items that are allowed in the study:
StudyEventDef describes a particular instance of a study event.
FormDef describes a particular instance of a form.
ItemDef describes a particular instance of an item.
ItemGroupDef describes a particular instance of an item group.
CodeList defines a discrete set of permitted values for an item or a more
human-readable description of an encoded value.
Metadata contains internal and external attributes that identify the entity for which
information is provided. The internal attributes designate entities within the model
and allow cross-references to be defined between entities, both within and between
CDISC ODM XML documents. Internal attributes include an object instance identifier
(OID), a subject key, and repeat keys.
3 An OID uniquely identifies each entity. For example, a StudyOID is assigned to
uniquely identify each study, a StudyEventOID is assigned to uniquely identify
each StudyEventDef within a study, a FormOID is assigned to uniquely identify
each form used in a StudyEventDef, and so on.
3 The subject key identifies a subject within a study.
3 The repeat key identifies an entity as one of a series. For example, there can be
several study events of a particular type for a particular subject. The repeat key
temporarily relates the distinct study events to each other.
The external attributes are used by clinical personnel to specify information that is
unique to the entity. These attributes include subject randomization codes, site codes,
and so on. Within CDISC ODM, the attributes are treated as part of the clinical trials
data.
The set of attributes that are required to reference a single entity is referred to as a
KeySet. For more information about the CDISC ODM KeySet, see “CDISC ODM
KeySet Members” on page 6.

CDISC ODM KeySet Members

What Is a CDISC ODM KeySet?

In a CDISC ODM XML document, a clinical trials data KeySet references an entity,
such as a study, a subject, a study event, and so on. The following is an excerpt from a
sample XML document that shows a fully populated KeySet:
<ClinicalData StudyOID="123-456-789" MetaDataVersionOID="v1.1.0">

<StudyEventData StudyEventOID="SE.VISIT1" StudyEventRepeatKey="1">

<FormData FormOID="FORM.AE" FormRepeatKey="1">

<ItemGroupData ItemGroupOID="IG.AE" ItemGroupRepeatKey="1"

TransactionType="Insert">

Converting CDISC ODM KeySet Members

PROC CDISC imports and exports CDISC ODM KeySet members as follows:
Importing and Exporting a CDISC ODM XML Document � Converting CDISC ODM KeySet Members 7

3 When importing, KeySet members (KeySet attributes) that are in the input XML
document are converted to SAS variables and values in the output SAS data set.
3 When exporting, KeySet members (SAS variables and values) that are in the input
SAS data set are converted to KeySet attributes in the output XML document.
The following tables list the results of importing and exporting KeySet members:

Table 2.1 Importing KeySet Members from a CDISC ODM XML Document

KeySet Member Description Resulting SAS Variable Name *

StudyOID= Speciﬁes a unique identiﬁer __STUDYOID
for the study.

MetaDataVersionOID= Speciﬁes the metadata __METADATAVERSIONOID

version that is used by the
study.

SubjectKey= Speciﬁes a subject within __SUBJECTKEY

the study.

StudyEventOID= Speciﬁes a StudyEventDef __STUDYEVENTOID

in the study.
StudyEventRepeatKey= Speciﬁes a study event __STUDYEVENTREPEATKEY
repeat key.

FormOID= Speciﬁes a FormDef in the __FORMOID

study.

FormRepeatKey= Distinguishes between __FORMREPEATKEY

repeats of the same type of
form in a single study
event.

ItemGroupOID= Speciﬁes an ItemGroup in __ITEMGROUPOID

the study.
ItemGroupRepeatKey= Speciﬁes an ItemGroup __ITEMGROUPREPEATKEY
repeat key.

TransactionType= Speciﬁes the transaction __TRANSACTIONTYPE

type, which can be Insert,
Update, Remove, Upsert, or
Context.

* The ﬁrst two characters in resulting SAS variable names are two underscores to ensure that
the name is unique.

Table 2.2 Exporting KeySet Members from a SAS Data Set

KeySet Member Description Resulting KeySet Created By

Attributes

__STUDYOID Speciﬁes a unique StudyOID= STUDY

identiﬁer for the statement
study.

__METADATAVERSIONOID Speciﬁes the MetaDataVersionOID= METADATAVERSION

metadata version statement
that is used by the
study.
8 Processing CDISC ODM KeySet Members � Chapter 2

KeySet Member Description Resulting KeySet Created By

Attributes

__SUBJECTKEY Speciﬁes a subject SubjectKey= Read from the

in the study. exported SAS
data set

__STUDYEVENTOID Speciﬁes a StudyEventOID= STUDY

StudyEventDef in statement
the study.
__STUDYEVENTREPEATKEY Speciﬁes a study StudyEventRepeatKey= Automatically
event repeat key. generated

__FORMOID Speciﬁes a FormOID= Automatically

FormDef in the generated
study.
__FORMREPEATKEY Distinguishes FormRepeatKey= Automatically
between repeats of generated
the same type of
form in a single
study event.
__ITEMGROUPOID Speciﬁes an ItemGroupOID= Automatically
ItemGroup in the generated
study.

__ITEMGROUPREPEATKEY Speciﬁes an ItemGroupRepeatKey= Automatically

ItemGroup repeat generated
key.

__TRANSACTIONTYPE Speciﬁes the TransactionType= INSERT is

transaction type, always used
which can be
Insert, Update,
Remove, Upsert,
or Context.

Processing CDISC ODM KeySet Members

PROC CDISC provides processing options that determine how KeySet members are
imported or exported. The following processing options are speciﬁed in the ODM
statement:
LONGNAMES=NO | YES

when importing or exporting, determines the sources of captured SAS name

parameters and controls the maximum length of SAS names that is valid.

ODMMAXIMUMOIDLENGTH=number
when importing, speciﬁes a character length for CDISC ODM KeySet members.
ODMMINIMUMKEYSET=NO|YES

when importing or exporting, speciﬁes whether to limit CDISC ODM KeySet

members that are in the study data.

For more information about processing options, see the “ODM Statement” on page 57.
Importing and Exporting a CDISC ODM XML Document � Introduction to CDISC ODM Metadata Attributes 9

For examples of how the KeySet processing options affect the data in an import
operation, see “Example: Importing a CDISC ODM XML Document Using Default
KeySet Processing” on page 16, and “Example: Importing a CDISC ODM XML
Document Specifying KeySet Processing Options” on page 19.

Specifying CDISC ODM Metadata Attributes

Introduction to CDISC ODM Metadata Attributes

Several CDISC procedure statements enable you to specify metadata attributes
either directly in the CDISC procedure statement or stored in a SAS data set that you
reference in the DATA= argument.
The DATA= argument enables you to use the same execution code for all operations.
It also enables you to change the metadata and data content by redirecting the
LIBNAME statement speciﬁcations to different locations, perhaps on a study basis.
Here is an example of an ODM statement that speciﬁes metadata attributes as part
of the statement syntax:

odm odmversion="1.2"
fileoid="000-00-0000"
filetype=SNAPSHOT
description="Adverse events from the CTChicago file";

The following example references those same metadata attributes stored in a SAS
data set:
odm data=current.odm;

The SAS DATA step code shows how CURRENT.ODM, which contains the metadata
attributes, is created:
data current.odm;
odmversion="1.2";
fileoid="000-00-0000";
filetype="SNAPSHOT";
description="Adverse events from the CTChicago file";
run;

The following example illustrates how the same PROC CDISC code can be used to
export data for many studies:

libname metadata ’c:\your-meta-library’;

libname clindata ’c:\your-data-library’;

filename xmlout ’c:\your-output\ae.xml’;

proc cdisc model=odm write=xmlout;

odm data=metadata.odm;
study data=metadata.study;
10 Specifying CDISC ODM Metadata Attributes When Importing � Chapter 2

globalvariables data=metadata.globals;

basicdefinitions data=metadata.basic;

metadataversion data=metadata.metadata;

presentation data=metadata.present;

user data=metadata.users;

location data=metadata.location;

signature data=metadata.signature;

clinicaldata data=clindata.ae;

run;

Specifying CDISC ODM Metadata Attributes When Importing

When importing a CDISC ODM XML document, you can specify the metadata
attribute for the version number either directly in the ODM statement or stored in a
SAS data set that you reference in the DATA= argument.
The following example imports data from a CDISC ODM ItemGroupDef element that
has a SASDatasetName= attribute value of AE. All KeySet members are written to the
output SAS data set named MY.AE. A maximum OID length of 16 characters is
allocated for each KeySet member. The metadata attribute for the ODM statement is
speciﬁed in the statement.

filename xmlinp ’CDISC-ODM-XML-document’;

proc cdisc model=odm read=xmlinp formatactive=yes formatnoreplace=no;

odm odmversion="1.2" odmmaximumoidlength=16 odmminimumkeyset=no;
clinicaldata out=my.ae sasdatasetname="AE";
run;

Specifying CDISC ODM Metadata Attributes When Exporting

When exporting a CDISC ODM XML document, follow these conventions:
3 You can specify metadata attributes for the required statements ODM, STUDY,
GLOBALVARIABLES, and METADATAVERSION either directly in the statement
or stored in a SAS data set that you reference in the DATA= argument.
Note: You cannot store some metadata attributes in a SAS data set, and also
specify other metadata attributes in the statement. If you use a SAS data set, you
must store all metadata attributes in the SAS data set. �
3 Optional metadata attributes for the CLINICALDATA statement must be speciﬁed
as part of the statement syntax. For example, in the following code, the SAS data
set MY.AE contains the KeySet members and clinical data content. DOMAIN=,
NAME=, and COMMENT= are optional export metadata attributes.
clinicaldata data=my.AE

domain="AE"

name="Adverse Events"

comment="All adverse events in this trial";

3 Metadata attributes for the optional statements BASICDEFINITIONS,

PRESENTATION, USER, LOCATION, and SIGNATURE must be submitted in a
SAS data set that you reference in the DATA= argument.
11

CHAPTER

3
Validating a CDISC SDTM SAS
Data Set

Introduction to CDISC SDTM 11

Validating a CDISC SDTM SAS Data Set 11
CDISC Procedure Capabilities for Validating a CDISC SDTM SAS Data Set 11

Introduction to CDISC SDTM

CDISC SDTM defines a standard structure for study data tabulation data sets that
are submitted as part of a product application to a regulatory authority such as the
U.S. Food and Drug Administration (FDA). CDISC SDTM was prepared by the CDISC
Submissions Data Standards (SDS) team to guide the organization, structure, and
format of the data sets. The data sets are one of four ways to represent the human
subject Case Report Tabulation (CRT) and equivalent animal data submitted to the
FDA.
CDISC SDTM includes several defined domains that are grouped within broad
categories. The model provides the ability to create custom-defined domains with sets of
standard variable definitions. Variables in common across domains have similar name
extensions, and to make them standard, the beginning prefix of each variable should
typically be a two-letter domain code.
PROC CDISC supports data validation for CDISC SDTM version 3.1.

Validating a CDISC SDTM SAS Data Set

To validate a SAS data set that conforms to CDISC SDTM, submit the PROC CDISC
statement and specify the MODEL=SDTM argument.
In addition, you must submit these statements:
3 SDTM statement to specify the SDTM version number
3 DOMAINDATA statement to specify the SAS data set, domain, and category

CDISC Procedure Capabilities for Validating a CDISC SDTM SAS Data Set
PROC CDISC performs the following checks on domain content:
3 Veriﬁes that all required variables are in the SAS data set.
3 Reports as an error any variables in the SAS data set that are not deﬁned in the
domain. Compared to CDISC SDS version 2.x, CDISC SDTM version 3.1 has more
restrictions.
12 CDISC Procedure Capabilities for Validating a CDISC SDTM SAS Data Set � Chapter 3

3 Reports a warning for any expected domain variables that are not in the SAS data
set. Compared to CDISC SDS version 2.x, CDISC SDTM version 3.1 has more
required domain variables.
3 Notes any permitted domain variables that are not in the SAS data set. PROC
CDISC finds general omissions, but it is up to the site administrator to determine
whether the omissions are appropriate.
3 Verifies that all domain variables are of the expected data type and proper length.
For example, the validation reports if the SAS data set has SAS date and time
variables that require ISO 8601 expansion.
3 Detects any domain variables that are assigned a controlled terminology
specification by the domain and do not have a SAS format assigned to them. Only
an assigned format is required.
PROC CDISC also performs the following checks on domain content on a
per-observation basis:
3 Verifies that all required variable fields do not contain missing values.
3 Detects occurrences of expected variable fields that contain missing values.
3 Detects the conformance of all ISO 8601 assigned values, including date, time,
datetime, duration, and interval types.
3 Notes correctness of YES or NO and YES, NO, or NULL responses.
With the exception of YES or NO and YES, NO, or NULL content, PROC CDISC does
not validate the content of controlled terminology against a list of acceptable values.
Note: PROC CDISC does not do the following operations:
3 Automatically generate a V5 XPORT file from the SAS data set.
3 Create an XML document. PROC CDISC performs STDM 3.1 data content
validation only.
�
13

2
P A R T

Usage

Chapter 4. . . . . . . . . . CDISC Procedure Examples for CDISC ODM 15

Chapter 5 . . . . . . . . . . CDISC Procedure Examples for CDISC SDTM 49

CHAPTER

4
CDISC Procedure Examples for
CDISC ODM

Example: Importing a CDISC ODM XML Document Using Default KeySet Processing 16

Overview 16

Program 16

Output 17

Example: Importing a CDISC ODM XML Document Specifying KeySet Processing Options 19

Overview 19

Program 19

Output 20

Example: Importing a CDISC ODM XML Document Using a Language Identiﬁer 21

Overview 21

Program 24

Output 25

Example: Importing a CDISC ODM XML Document with OrderNumber Attributes 27

Overview 27

Program 27

Output 27

Example: Exporting a CDISC ODM XML Document with Metadata Attributes in Statement Syntax 28

Overview 28

Program 28

Output 29

Example: Exporting a CDISC ODM XML Document with Metadata Attributes in SAS Data Sets 33

Overview 33

Program 34

Output 36

Example: Exporting a CDISC ODM XML Document with Required and Optional Statements 38

Overview 38

Program 39

Example: Describing a CDISC ODM SAS Data Set with the CONTENTS Statement 42

Overview 42

Program with LONGNAMES=NO 42

Output with LONGNAMES=NO 44

Program with LONGNAMES=YES 44

Output with LONGNAMES=YES 45

Example: Listing a Directory with the DATASETS Statement 46

Overview 46

Program with LONGNAMES=NO 46

Output with LONGNAMES=NO 47

Program with LONGNAMES=YES 47

Output with LONGNAMES=YES 48

16 Example: Importing a CDISC ODM XML Document Using Default KeySet Processing � Chapter 4

Example: Importing a CDISC ODM XML Document Using Default KeySet

Processing

Overview
This example imports clinical trials data from a CDISC ODM XML document that is
named AE.XML, and creates a SAS data set that is named RESULTS.AE.
The example illustrates the default behavior for KeySet members written to the
output SAS data set. All KeySet members that are in the input XML document are
converted to SAS variables and values in the output SAS data set.
To view the AE.XML document, see “Sample CDISC ODM XML Document” on page
81.

Program
The following SAS program imports the XML document as a SAS data set:
1 The LIBNAME statement assigns the libref RESULTS to the physical location of
the output SAS data set.
2 The FILENAME statement assigns the fileref XMLINP to the physical location of
the input XML document (complete pathname, filename, and file extension) to be
imported.
3 The PROC CDISC statement specifies the following:
3 CDISC ODM as the model.
3 Fileref XMLINP, which references the physical location of the input XML
document to be imported.
3 FORMATACTIVE=YES to convert CDISC ODM CodeList content in the XML
document to SAS formats.
3 FORMATNOREPLACE=NO to replace existing SAS formats in the FORMAT
catalog that have the same name as the converted formats.
4 ODMMINIMUMKEYSET=NO in the ODM statement specifies that all KeySet
members are written to the output SAS data set. This is the default setting for
ODMMINIMUMKEYSET=.
5 The CLINICALDATA statement identifies the output SAS data set, which is

RESULTS.AE, and speciﬁes the CDISC ODM ItemGroupDef attribute that

indicates where the data content in the XML document begins, which is AE.

6 The CONTENTS procedure lists the contents of the output SAS data set. The
VARNUM option lists the variables in the order in which they were created.
libname results ’C:\myfiles\’; u

filename xmlinp ’C:\XML\ae.xml’; v

proc cdisc model=odm w

read=xmlinp

formatactive=yes

formatnoreplace=no;

odm odmversion="1.2" odmminimumkeyset=no; x

clinicaldata out=results.AE sasdatasetname="AE"; y

run;
CDISC Procedure Examples for CDISC ODM � Output 17

proc contents data=results.AE varnum; U

run;

filename xmlinp clear;

libname results clear;

Output
The output from PROC CONTENTS displays the attributes of each interpreted
variable, such as the variable’s type and length. The attributes are obtained from the
embedded metadata content.
Because ODMMINIMUMKEYSET=NO, all KeySet members are written to the
output SAS data set. These are the ﬁrst 10 variables listed in the output. (The ﬁrst two
characters in resulting SAS variable names are two underscores.)
The maximum OID length, which is 100, is allocated to each KeySet member.
18 Output � Chapter 4

Output 4.1 PROC CONTENTS Output for RESULTS.AE

The SAS System 1

The CONTENTS Procedure

Data Set Name RESULTS.AE Observations 2

Member Type DATA Variables 29
Engine V9 Indexes 0
Created Monday, March 09, 2009 10:25:34 AM Observation Length 1208
Last Modified Monday, March 09, 2009 10:25:34 AM Deleted Observations 0
Protection Compressed NO
Data Set Type Sorted NO
Label Some adverse events from this trial
Data Representation WINDOWS_32
Encoding wlatin1 Western (Windows)

Engine/Host Dependent Information

Data Set Page Size 16384

Number of Data Set Pages 1
First Data Page 1
Max Obs per Page 13
Obs in First Data Page 2
Number of Data Set Repairs 0
Filename C:\ae.sas7bdat
Release Created 9.0202M0
Host Created XP_PRO

The SAS System 10:23 Monday, March 9, 2009 2

The CONTENTS Procedure

Variables in Creation Order

# Variable Type Len Format Informat

1 __StudyOID Char 100

2 __MetaDataVersionOID Char 100
3 __SubjectKey Char 100
4 __StudyEventOID Char 100
5 __StudyEventRepeatKey Char 100
6 __FormOID Char 100
7 __FormRepeatKey Char 100
8 __ItemGroupOID Char 100
9 __ItemGroupRepeatKey Char 100
10 __TransactionType Char 100
11 TAREA Char 4 $TAREAF.
12 PNO Char 15
13 SCTRY Char 4 $SCTRYF.
14 F_STATUS Char 1 $F_STATU.
15 LINE_NO Num 8 2.
16 AETERM Char 100
17 AESTMON Num 8 2.
18 AESTDAY Num 8 2.
19 AESTYR Num 8 4.
20 AESTDT Num 8 DATE.
21 AEENMON Num 8 2.
22 AEENDAY Num 8 2.
23 AEENYR Num 8 4.
24 AEENDT Num 8 DATE.
25 AESEV Char 1 $AESEV.
26 AEREL Char 1 $AEREL.
27 AEOUT Char 1 $AEOUT.
28 AEACTTRT Char 1 $AEACTTR.
29 AECONTRT Char 1 $AECONTR.
CDISC Procedure Examples for CDISC ODM � Program 19

Example: Importing a CDISC ODM XML Document Specifying KeySet

Processing Options

Overview
This example imports clinical trials data from a CDISC ODM XML document that is
named AE.XML, and creates a SAS data set that is named RESULTS.AEMIN.
The example illustrates the results of specifying the KeySet processing options
ODMMINIMUMKEYSET=YES and ODMMAXIMUMOIDLENGTH= in the ODM
statement. Only the unique SubjectKey member is written to the output SAS data set.
The character length for the KeySet members is reduced from the default OID length.
To view the AE.XML document, see “Sample CDISC ODM XML Document” on page
81.

SubjectKey is written to the output SAS data set.

ODMMAXIMUMOIDLENGTH=18 in the ODM statement allocates a storage

space of 18 characters for the KeySet member character length, instead of the
default maximum OID length.
5 The CLINICALDATA statement identiﬁes the output SAS data set, which is
RESULTS.AEMIN, and speciﬁes the CDISC ODM ItemGroupDef attribute that
indicates where the data content in the XML document begins, which is AE.
6 The CONTENTS procedure lists the contents of the output SAS data set. The
VARNUM option lists the variables in the order in which they were created.
libname results ’C:\myfiles\’; u

filename xmlinp ’C:\XML\ae.xml’; v

proc cdisc model=odm w

read=xmlinp

formatactive=yes

formatnoreplace=no;

20 Output � Chapter 4

odm odmversion="1.2"
odmminimumkeyset=yes x
odmmaximumoidlength=18;

clinicaldata out=results.AEMIN sasdatasetname="AE"; y

run;

filename xmlinp clear;

proc contents data=results.AEMIN varnum; U

run;

libname results clear;

Output
The output from PROC CONTENTS displays the attributes of each interpreted
variable, such as the variable’s type and length. The attributes are obtained from the
embedded metadata content.
Because ODMMINIMUMKEYSET=YES, only the SubjectKey is written to the output
SAS data set, which is the ﬁrst variable listed in the output.
Because ODMMAXIMUMOIDLENGTH=18, an OID length of 18 is allocated.
CDISC Procedure Examples for CDISC ODM � Overview 21

Output 4.2 PROC CONTENTS Output for RESULTS.AEMIN

The SAS System 1

The CONTENTS Procedure

Data Set Name RESULTS.AEMIN Observations 2

Member Type DATA Variables 20
Engine V9 Indexes 0
Created Monday, March 09, 2009 10:45:26 AM Observation Length 224
Last Modified Monday, March 09, 2009 10:45:26 AM Deleted Observations 0
Protection Compressed NO
Data Set Type Sorted NO
Label Some adverse events from this trial
Data Representation WINDOWS_32
Encoding wlatin1 Western (Windows)

Engine/Host Dependent Information

Data Set Page Size 16384

Number of Data Set Pages 1
First Data Page 1
Max Obs per Page 72
Obs in First Data Page 2
Number of Data Set Repairs 0
Filename C:\aemin.sas7bdat
Release Created 9.0202M0
Host Created XP_PRO

Variables in Creation Order

# Variable Type Len Format Informat

1 __SubjectKey Char 18
2 TAREA Char 4 $TAREAF.
3 PNO Char 15
4 SCTRY Char 4 $SCTRYF.
5 F_STATUS Char 1 $F_STATU.
6 LINE_NO Num 8 2.
7 AETERM Char 100
8 AESTMON Num 8 2.
9 AESTDAY Num 8 2.
10 AESTYR Num 8 4.
11 AESTDT Num 8 DATE.
12 AEENMON Num 8 2.
13 AEENDAY Num 8 2.
14 AEENYR Num 8 4.
15 AEENDT Num 8 DATE.
16 AESEV Char 1 $AESEV.
17 AEREL Char 1 $AEREL.
18 AEOUT Char 1 $AEOUT.
19 AEACTTRT Char 1 $AEACTTR.
20 AECONTRT Char 1 $AECONTR.

Example: Importing a CDISC ODM XML Document Using a Language

Identiﬁer

Overview
This example imports clinical trials data from a CDISC ODM XML document by
specifying a language identiﬁer with the LANGUAGE= option in the PROC CDISC
22 Overview � Chapter 4

statement. By specifying the LANGUAGE= option, PROC CDISC locates the matching
language identiﬁer in the ODM TranslatedText element. It creates a SAS format by
using the TranslatedText items with a matching language tag attribute (xml:lang). The
created SAS format is then applied to the data that is imported from the XML
document.
This example imports the following XML document:

<?xml version="1.0" encoding="windows-1252" ?>

<!-
Clinical Data Interchange Standards Consortium (CDISC)

Operational Data Model (ODM) for clinical data interchange

You can learn more about CDISC standards efforts at

http://www.cdisc.org/standards/index.html

-->

<ODM xmlns="http://www.cdisc.org/ns/odm/v1.2"

xmlns:ds="http://www.w3.org/2000/09/xmldsig#"

xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"

xsi:schemaLocation="http://www.cdisc.org/ns/odm/v1.2 ODM1-2-0.xsd"

ODMVersion="1.2"

FileOID="000-00-0000"

FileType="Snapshot"

Description="testing codelist stuff"

AsOfDateTime="2006-11-03T09:47:53"

CreationDateTime="2006-11-03T09:47:53"

SourceSystem="SAS"

SourceSystemVersion="GENERIC"

<GlobalVariables>
<StudyName>CODELIST</StudyName>
<StudyDescription>Checking Codelists</StudyDescription>
<ProtocolName>Protocol</ProtocolName>
</GlobalVariables>

<!-
Internal ODM markup required metadata
-->
<MetaDataVersion OID="MDV_CODELIST" Name="MDV Codelist">
<Protocol>
<StudyEventRef StudyEventOID="StudyEventOID" OrderNumber="1"
Mandatory="Yes" />
</Protocol>
CDISC Procedure Examples for CDISC ODM � Overview 23

<StudyEventDef OID="StudyEventOID" Name="Study Event Definition"

Repeating="Yes" Type="Common">
<FormRef FormOID="X" OrderNumber="1" Mandatory="No" />
</StudyEventDef>

<FormDef OID="X" Name="Form Definition" Repeating="Yes">

<!-
Columns defined in the table
-->
<ItemGroupDef OID="X" Repeating="Yes"
SASDatasetName="X"
Name="ODM Examples"
Comment="Examples of ODM Datatypes">
<ItemRef ItemOID="ID.x" OrderNumber="1" Mandatory="No" />
</ItemGroupDef>

<!-
Column attributes as defined in the table
-->
<ItemDef OID="ID.x" SASFieldName="x" Name="x" DataType="float" Length="12"
SignificantDigits="2" Comment="x">
<CodeListRef CodeListOID="CL.NUMBERS" />
</ItemDef>

<!-
Translation to ODM markup for any PROC FORMAT style
user defined or SAS internal formatting specifications
applied to columns in the table
-->
<CodeList OID="CL.NUMBERS" SASFormatName="NUMBERS" Name="NUMBERS"
DataType="float">
<CodeListItem CodedValue="1">
<Decode>

</Decode>

</CodeListItem>

</Decode>

</CodeListItem>

24 Program � Chapter 4

<TranslatedText xml:lang="en">three</TranslatedText>

</Decode>

</CodeListItem>

</CodeList>

</MetaDataVersion>

</Study>

<!-
Administrative metadata

-->

<!-
Actual data content begins here

This section represents each data record in the table

-->
<ClinicalData StudyOID="AStudyOID" MetaDataVersionOID="MDV_CODELIST">
<SubjectData SubjectKey="001">
<StudyEventData StudyEventOID="StudyEventOID" StudyEventRepeatKey="1">
<FormData FormOID="X" FormRepeatKey="1">
<ItemGroupData ItemGroupOID="X" ItemGroupRepeatKey="1">
<ItemData ItemOID="ID.x" Value="3" />
</ItemGroupData>
</FormData>
</StudyEventData>
</SubjectData>
</ClinicalData>
</ODM>

Program
The following SAS program imports the XML document as a SAS data set:
1 The LIBNAME statement assigns the libref RESULTS to the physical location of
the output SAS data set.
2 The FILENAME statement assigns the fileref XMLINP to the physical location of
the input XML document (complete pathname, filename, and file extension) to be
imported.
3 The PROC CDISC statement specifies the following:
3 CDISC ODM as the model.
3 Fileref XMLINP, which references the physical location of the input XML
document to be imported.
3 FORMATACTIVE=YES to convert CDISC ODM CodeList content in the XML
document to SAS formats.
3 FORMATNOREPLACE=NO to replace existing SAS formats in the FORMAT
catalog that have the same name as the converted formats.
3 LANGUAGE="DE" to specify a language identifier with a two-letter language
code. PROC CDISC locates the DE language identifier in the ODM
TranslatedText element and creates a SAS format by using the TranslatedText
items with a matching language tag attribute. The created SAS format is then
applied to the data that is imported from the XML document.
CDISC Procedure Examples for CDISC ODM � Output 25

4 ODMMINIMUMKEYSET=NO in the ODM statement speciﬁes that all KeySet

members are written to the output SAS data set. This is the default setting for
ODMMINIMUMKEYSET=.
5 The CLINICALDATA statement identiﬁes the output SAS data set, which is
RESULTS.NUMBERS, and speciﬁes the CDISC ODM ItemGroupDef attribute
that indicates where the data content in the XML document begins, which is X.
6 The CONTENTS procedure lists the contents of the output SAS data set.
7 The PRINT procedure prints the rows in the output SAS data set. The VAR
statement selects just the X variable.
libname results ’C:\myfiles\’; u

filename xmlinp ’C:\XML\numbers.xml’; v

proc cdisc model=odm w

read=xmlinp
formatactive=yes
formatnoreplace=no
language="de";
odm odmversion="1.2" odmminimumkeyset=no; x
clinicaldata out=results.numbers sasdatasetname="X"; y
run;

filename xmlinp clear;

proc contents data=results.numbers; U

run;

proc print data=results.numbers; V

var x;
run;

libname results clear;

Output
The output from PROC CONTENTS displays the attributes of each interpreted
variable, which includes the SAS variable X and all KeySet members.
26 Output � Chapter 4

Output 4.3 PROC CONTENTS Output for RESULTS.NUMBERS

The SAS System 1

The CONTENTS Procedure

Data Set Name RESULTS.NUMBERS Observations 1

Member Type DATA Variables 11

Engine V9 Indexes 0

Created Tuesday, March 03, 2009 03:07:26 PM Observation Length 1008

Last Modified Tuesday, March 03, 2009 03:07:26 PM Deleted Observations 0

Protection Compressed NO

Data Set Type Sorted NO

Label Examples of ODM Datatypes

Data Representation WINDOWS_32

Encoding wlatin1 Western (Windows)

Engine/Host Dependent Information

Data Set Page Size 16384

Number of Data Set Pages 1

First Data Page 1

Max Obs per Page 16

Obs in First Data Page 1

Number of Data Set Repairs 0

Filename C:\numbers.sas7bdat

Release Created 9.0202M0

Host Created XP_PRO

Alphabetic List of Variables and Attributes

# Variable Type Len Format Informat Label

11 X Num 8 NUMBERS. 12.2 x

6 __FormOID Char 100

7 __FormRepeatKey Char 100

8 __ItemGroupOID Char 100

9 __ItemGroupRepeatKey Char 100

2 __MetaDataVersionOID Char 100

4 __StudyEventOID Char 100

5 __StudyEventRepeatKey Char 100

1 __StudyOID Char 100

3 __SubjectKey Char 100

10 __TransactionType Char 100

The output from PROC PRINT lists the value for the imported SAS variable X. The
procedure applies the SAS format NUMBERS, which is created by using the
TranslatedText item with the matching language tag attribute DE. It applies
NUMBERS to the data that is imported from the XML document, which is 3. The
result is the German word drei.

Output 4.4 PROC PRINT Output for Variable X with Applied SAS Format

The SAS System 1

Obs X

1 drei

CDISC Procedure Examples for CDISC ODM � Output 27

Example: Importing a CDISC ODM XML Document with OrderNumber

Attributes

Overview
This example imports a CDISC ODM XML document that contains OrderNumber
attributes that are not in sequence. PROC CDISC validates the attributes and displays
warnings in the SAS log.

Program
The following SAS program imports the XML document as a SAS data set:

1 The LIBNAME statement assigns the libref RESULTS to the physical location of
the output SAS data set.
2 The FILENAME statement assigns the fileref XMLINP to the physical location of
the input XML document (complete pathname, filename, and file extension) to be
imported.
3 The PROC CDISC statement specifies the following:
3 CDISC ODM as the model.
3 Fileref XMLINP, which references the physical location of the input XML
document to be imported.
4 ORDERNUMBER=YES in the ODM statement specifies to validate whether
OrderNumber attributes conform to the model specifications. This is the default
setting for ORDERNUMBER=
5 The CLINICALDATA statement identifies the output SAS data set, which is

RESULTS.AE, and speciﬁes the CDISC ODM ItemGroupDef attribute that

indicates where the data content in the XML document begins, which is AE.

libname results ’C:\myfiles\’; u

filename xmlinp ’C:\XML\ae.xml’; v

proc cdisc model=odm read=xmlinp; w

odm odmversion="1.2" ordernumber=yes; x

clinicaldata out=results.AE sasdatasetname="AE"; y

run;

filename xmlinp clear;

libname results clear;

Output
The following SAS log displays a warning that the ItemRef element contains an
OrderNumber attribute that is out of sequence.
28 Example: Exporting a CDISC ODM XML Document with Metadata Attributes in Statement Syntax � Chapter 4

238 libname results ’C:\myfiles\’;

NOTE: Libref RESULTS was successfully assigned as follows:
Engine: V9
Physical Name: C:\myfiles\
239

240 filename xmlinp ’C:\XML\ae.xml’;

241

242 proc cdisc model=odm read=xmlinp;

243 odm odmversion="1.2" ordernumber=yes;

244 clinicaldata out=results.AE sasdatasetname="AE";

245 run;

WARNING: ItemRef OID="ID.AESEV" OrderNumber="21" outside range. Ignoring OrderNumber.

NOTE: PROCEDURE CDISC used (Total process time):

real time 4.76 seconds
cpu time 0.01 seconds

Example: Exporting a CDISC ODM XML Document with Metadata

Attributes in Statement Syntax

Overview
This example, which includes only the required PROC CDISC statements for
exporting, speciﬁes the metadata attributes in the statements.
As an alternative, you can store metadata attributes for the required ODM, STUDY,
GLOBALVARIABLES, and METADATAVERSION statements in separate SAS data sets
that you reference with the DATA= argument. For an example, see “Example: Exporting
a CDISC ODM XML Document with Metadata Attributes in SAS Data Sets” on page 33.

Program
The following SAS program exports a SAS data set as a CDISC ODM XML document:
1 The LIBNAME statement assigns the libref RESULTS to the physical location of
the input SAS data set.
2 The FILENAME statement assigns the fileref XMLOUT to the physical location of
the output XML document (complete pathname, filename, and file extension) to be
exported.
3 The SORT procedure specifies to sort the input SAS data set by the

__SUBJECTKEY variable.

4 The PROC CDISC statement speciﬁes the following:

3 CDISC ODM as the model.
3 Fileref XMLOUT, which references the physical location of the output XML
document to be exported.
3 FORMATACTIVE=YES to convert CDISC ODM CodeList content in the XML
document to SAS formats.
3 FORMATNOREPLACE=NO to replace existing SAS formats in the FORMAT
catalog that have the same name as the converted formats.
5 The ODM statement specifies the required metadata attributes for exporting, such
as the CDISC ODM version and file type.
6 The STUDY statement specifies the study identifier.
CDISC Procedure Examples for CDISC ODM � Output 29

7 Options in the GLOBALVARIABLES statement specify general summary

information about the study.
8 The METADATAVERSION statement specifies the required metadata version and
version name.
9 The CLINICALDATA statement identifies the input SAS data set, which is
RESULTS.AE. The input SAS data set contains the data content and KeySet
members that are written to the XML document. In addition, the CLINICALDATA
statement specifies optional metadata attributes.
libname results ’C:\myfiles\’; u

filename xmlout ’C:\XML\AEfull.XML’; v

proc sort data=results.AE; w

by __subjectkey;
run:

proc cdisc model=odm x

write=xmlout
formatactive=yes
formatnoreplace=no;

odm odmversion="1.2" y

fileoid="000-00-0000"

filetype=SNAPSHOT

description="Adverse events from the CTChicago file";

study studyoid="STUDY.StudyOID";U

globalvariables studyname="CDISC Connect-A-Thon Test Study III" V

studydescription="This file contains test data for the CDISC
Connect-A-Thon event scheduled for the DIA
38th annual meeting in Chicago."
protocolname="CDISC-Protocol-00-000";

metadataversion metadataversionoid="v1.1.0" W

name="Version 1.1.0";

clinicaldata data=results.AE X

domain="AE"

name="Adverse Events"

comment="All adverse events in this trial" ;

run;

filename xmlout clear;

libname results clear;

Output
The following is an annotated excerpt of the output CDISC ODM XML document:
1 All of the metadata is contained by a single MetaDataVersion element.
2 A Protocol element that contains a StudyEventRef for each StudyEventDef is
automatically generated.
30 Output � Chapter 4

3 A StudyEventDef element that contains a FormRef for each FormDef is

automatically generated.
4 A FormDef element that contains an ItemGroupRef for each ItemGroupDef is
automatically generated.
5 The SAS data set is represented as an ItemGroupDef.
6 Each variable in the SAS data set is represented as an ItemRef.
7 If a variable contains a reference to a user-deﬁned SAS format, a CodeListRef is
generated in the ItemDef for the variable.
8 A CodeList element is generated for each unique user-deﬁned SAS format that is
referenced.
9 A ClinicalData element is created for each ItemGroupDef that is referenced.
CDISC Procedure Examples for CDISC ODM � Output 31

Output 4.5 CDISC ODM XML Document Exported by PROC CDISC

<?xml version="1.0" encoding="windows-1252" ?>

<!-
Clinical Data Interchange Standards Consortium (CDISC)
Operational Data Model (ODM) for clinical data interchange

You can learn more about CDISC standards efforts at

http://www.cdisc.org/standards/index.html

-->

<ODM xmlns="http://www.cdisc.org/ns/odm/v1.2"
xmlns:ds="http://www.w3.org/2000/09/xmldsig#"
xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
xsi:schemaLocation="http://www.cdisc.org/ns/odm/v1.2 ODM1-2-0.xsd"

ODMVersion="1.2"

FileOID="000-00-0000"

FileType="Snapshot"

Description="Adverse events from the CTChicago file"

AsOfDateTime="2009-02-27T14:20:31"

CreationDateTime="2009-02-27T14:20:31"

SourceSystem="SAS 9.2 PROC CDISC"

SourceSystemVersion="9.02.02M0D01222009 3.00.65">

<!--

GlobalVariables is a REQUIRED section in ODM markup

-->

<StudyName>CDISC Connect-A-Thon Test Study III</StudyName>

<StudyDescription>This file contains test data for the CDISC Connect-A-Thon event

scheduled for the DIA 38th annual meeting in Chicago.</StudyDescription>

<ProtocolName>CDISC-Protocol-00-000</ProtocolName>

</GlobalVariables>

<!-
Internal ODM markup required metadata

-->

<MetaDataVersion OID="v1.1.0" Name="Version 1.1.0"> u

<Protocol> v

<StudyEventRef StudyEventOID="SE.VISIT1" OrderNumber="1" Mandatory="Yes" />

</Protocol>

<StudyEventDef OID="SE.VISIT1" Name="Study Event Definition" Repeating="Yes" Type="Common"> w

<FormDef OID="FORM.AE" Name="Form Definition" Repeating="Yes"> x

<ItemGroupRef ItemGroupOID="IG.AE" Mandatory="No" />

</FormDef>

<!-
Columns defined in the table

-->

<ItemGroupDef OID="IG.AE" Repeating="Yes" y

SASDatasetName="AE"

Name="Adverse Events"

Domain="AE"

Comment="All adverse events in this trial">

<ItemRef ItemOID="ID.TAREA" OrderNumber="1" Mandatory="No" /> U

<ItemRef ItemOID="ID.PNO" OrderNumber="2" Mandatory="No" />

<ItemRef ItemOID="ID.SCTRY" OrderNumber="3" Mandatory="No" />

<ItemRef ItemOID="ID.F_STATUS" OrderNumber="4" Mandatory="No" />

</ItemGroupDef>
32 Output � Chapter 4

<!-
Column attributes as defined in the table
-->
<ItemDef OID="ID.TAREA" Name="TAREA" SASFieldName="TAREA" DataType="text" Length="4">
<CodeListRef CodeListOID="CL.$TAREAF" /> V
</ItemDef>
<ItemDef OID="ID.PNO" Name="PNO" SASFieldName="PNO" DataType="text" Length="15" />
<ItemDef OID="ID.SCTRY" Name="SCTRY" SASFieldName="SCTRY" DataType="text" Length="4">
<CodeListRef CodeListOID="CL.$SCTRYF" />
</ItemDef>
<ItemDef OID="ID.F_STATUS" Name="F_STATUS" SASFieldName="F_STATUS" DataType="text" Length="1">
<CodeListRef CodeListOID="CL.$F_STATU" />
</ItemDef>
<ItemDef OID="ID.LINE_NO" Name="LINE_NO" SASFieldName="LINE_NO" DataType="integer" Length="2" />
.

<ItemDef OID="ID.AECONTRT" Name="AECONTRT" SASFieldName="AECONTRT" DataType="text" Length="1">

<!-
Translation to ODM markup for any PROC FORMAT style

user defined or SAS internal formatting specifications

applied to columns in the table

-->
<CodeList OID="CL.$TAREAF" SASFormatName="$TAREAF" Name="$TAREAF" DataType="text"> W
<CodeListItem CodedValue=’ONC’>
<Decode>
<TranslatedText>Oncology</TranslatedText>
</Decode>
</CodeListItem>
</CodeList>

<CodeList OID="CL.$AECONTR" SASFormatName="$AECONTR" Name="$AECONTR" DataType="text">

</CodeListItem>

<TranslatedText>Medication required</TranslatedText>

</Decode>

</CodeListItem>

<Decode>
<TranslatedText>Hospitalization required or prolonged</TranslatedText>
</Decode>

</CodeListItem>

<TranslatedText>Other</TranslatedText>

</Decode>

</CodeListItem>

</CodeList>

</MetaDataVersion>

</Study>

<!-
Administrative metadata

-->

CDISC Procedure Examples for CDISC ODM � Overview 33

<!-
Actual data content begins here

This section represents each data record in the table

-->
<ClinicalData StudyOID="STUDY.StudyOID" MetaDataVersionOID="v1.1.0"> X
<SubjectData SubjectKey="001">
<StudyEventData StudyEventOID="SE.VISIT1" StudyEventRepeatKey="1">
<FormData FormOID="FORM.AE" FormRepeatKey="1">
<ItemGroupData ItemGroupOID="IG.AE" ItemGroupRepeatKey="1">
<ItemData ItemOID="ID.TAREA" Value="ONC" />
<ItemData ItemOID="ID.PNO" Value="143-02" />
<ItemData ItemOID="ID.SCTRY" Value="USA" />
<ItemData ItemOID="ID.F_STATUS" Value="V" />
<ItemData ItemOID="ID.LINE_NO" Value="1" />
<ItemData ItemOID="ID.AETERM" Value="HEADACHE" />
<ItemData ItemOID="ID.AESTMON" Value="6" />
<ItemData ItemOID="ID.AESTDAY" Value="10" />
<ItemData ItemOID="ID.AESTYR" Value="1999" />
<ItemData ItemOID="ID.AESTDT" Value="1999-06-10" />
<ItemData ItemOID="ID.AEENMON" Value="6" />
<ItemData ItemOID="ID.AEENDAY" Value="14" />
<ItemData ItemOID="ID.AEENYR" Value="1999" />
<ItemData ItemOID="ID.AEENDT" Value="1999-06-14" />
<ItemData ItemOID="ID.AESEV" Value="1" />
<ItemData ItemOID="ID.AEREL" Value="0" />
<ItemData ItemOID="ID.AEOUT" Value="1" />
<ItemData ItemOID="ID.AEACTTRT" Value="0" />
<ItemData ItemOID="ID.AECONTRT" Value="1" />
</ItemGroupData>
<ItemGroupData ItemGroupOID="IG.AE" ItemGroupRepeatKey="2">
<ItemData ItemOID="ID.TAREA" Value="ONC" />
<ItemData ItemOID="ID.PNO" Value="143-02" />
<ItemData ItemOID="ID.SCTRY" Value="USA" />
<ItemData ItemOID="ID.F_STATUS" Value="V" />
<ItemData ItemOID="ID.LINE_NO" Value="2" />
<ItemData ItemOID="ID.AETERM" Value="CONGESTION" />
<ItemData ItemOID="ID.AESTMON" Value="6" />
<ItemData ItemOID="ID.AESTDAY" Value="11" />
<ItemData ItemOID="ID.AESTYR" Value="1999" />
<ItemData ItemOID="ID.AESTDT" Value="1999-06-11" />
<ItemData ItemOID="ID.AEENMON" IsNull="Yes" />
<ItemData ItemOID="ID.AEENDAY" IsNull="Yes" />
<ItemData ItemOID="ID.AEENYR" IsNull="Yes" />
<ItemData ItemOID="ID.AEENDT" IsNull="Yes" />
<ItemData ItemOID="ID.AESEV" Value="1" />
<ItemData ItemOID="ID.AEREL" Value="0" />
<ItemData ItemOID="ID.AEOUT" Value="2" />
<ItemData ItemOID="ID.AEACTTRT" Value="0" />
<ItemData ItemOID="ID.AECONTRT" Value="1" />
</ItemGroupData>
</FormData>
</StudyEventData>
</SubjectData>
</ClinicalData>
</ODM>

Example: Exporting a CDISC ODM XML Document with Metadata

Attributes in SAS Data Sets

Overview
This example, which includes only the required PROC CDISC statements for
exporting, illustrates how to specify metadata attributes that are stored in SAS data
34 Program � Chapter 4

sets and referenced in the DATA= argument. For information about the advantages of
using this method, see “Specifying CDISC ODM Metadata Attributes” on page 9.
When exporting, you can specify metadata attributes for the required ODM, STUDY,
GLOBALVARIABLES, and METADATAVERSION statements either directly in the
CDISC procedure statement or stored in a SAS data set. However, the optional
metadata attributes for the required CLINICALDATA statement must be speciﬁed as
part of the CLINICALDATA statement syntax.

Program
First, create SAS data sets that contain metadata attributes. The LIBNAME
statement assigns the libref CURRENT to the physical location of the SAS data sets
that will store the metadata attributes.
libname current ’C:\mydata\’;

data current.odm;

odmversion="1.2";

fileoid="ODM.FileOID";

filetype="Snapshot";

description="Optional descriptive information";

run;

data current.study;

studyoid="OID.StudyOID";

run;

data current.globals;

studyname="CDISC Test Study III";

studydescription="This file contains test data for CDISC testing";

protocolname="CDISC-Protocol-00-0000";

run;

data current.metadata;

metadataversionoid="v1.1.0";

name="Version 1.1.0";

run;

Then, reference the SAS data sets in a PROC CDISC program:

7 The required CLINICALDATA statement identiﬁes the input SAS data set, which
is CURRENT.AE. The input SAS data set contains the data content and KeySet
members that are written to the XML document. In addition, the CLINICALDATA
statement speciﬁes optional metadata attributes.

filename xmlout ’C:\XML\aeds.xml’; u

proc cdisc model=odm write=xmlout; v

odm data=current.odm; w

study data=current.study; x

globalvariables data=current.globals; y

metadataversion data=current.metadata; U

clinicaldata data = current.ae V

domain="AE"

name="Adverse Events"

comment="All adverse events in this trial";

run;

filename xmlout clear;

36 Output � Chapter 4

Output
The following output shows the exported XML document:

Output 4.6 CDISC ODM XML Document Exported by PROC CDISC

<?xml version="1.0" encoding="windows-1252" ?>

<!-
Clinical Data Interchange Standards Consortium (CDISC)
Operational Data Model (ODM) for clinical data interchange

You can learn more about CDISC standards efforts at

http://www.cdisc.org/standards/index.html

-->

ODMVersion="1.2"

FileOID="ODM.FileOID"

FileType="Snapshot"

Description="Optional descriptive information"

AsOfDateTime="2009-03-09T12:45:33"

CreationDateTime="2009-03-09T12:45:33"

SourceSystem="SAS 9.2 PROC CDISC"

SourceSystemVersion="9.02.02M0D01222009 3.00.65">

<!--

GlobalVariables is a REQUIRED section in ODM markup

-->

<GlobalVariables>
<StudyName>CDISC Test Study III</StudyName>
<StudyDescription>This file contains test data for CDISC testing</StudyDescription>
<ProtocolName>CDISC-Protocol-00-0000</ProtocolName>
</GlobalVariables>

<!-
Internal ODM markup required metadata

-->

<MetaDataVersion OID="v1.1.0" Name="Version 1.1.0">

<StudyEventRef StudyEventOID="SE.VISIT1" OrderNumber="1" Mandatory="Yes" />

</Protocol>

<StudyEventDef OID="SE.VISIT1" Name="Study Event Definition" Repeating="Yes" Type="Common">

<FormDef OID="FORM.AE" Name="Form Definition" Repeating="Yes">

<ItemGroupRef ItemGroupOID="IG.AE" Mandatory="No" />

</FormDef>

CDISC Procedure Examples for CDISC ODM � Output 37

<!-
Columns defined in the table
-->
<ItemGroupDef OID="IG.AE" Repeating="Yes"

SASDatasetName="AE"

Name="Adverse Events"

Domain="AE"

Comment="All adverse events in this trial">

<ItemRef ItemOID="ID.TAREA" OrderNumber="1" Mandatory="No" />

<ItemRef ItemOID="ID.PNO" OrderNumber="2" Mandatory="No" />

<ItemRef ItemOID="ID.SCTRY" OrderNumber="3" Mandatory="No" />

<ItemRef ItemOID="ID.F_STATUS" OrderNumber="4" Mandatory="No" />

<ItemRef ItemOID="ID.LINE_NO" OrderNumber="5" Mandatory="No" />

<ItemRef ItemOID="ID.AETERM" OrderNumber="6" Mandatory="No" />

<ItemRef ItemOID="ID.AESTMON" OrderNumber="7" Mandatory="No" />

<ItemRef ItemOID="ID.AESTDAY" OrderNumber="8" Mandatory="No" />

<ItemRef ItemOID="ID.AESTYR" OrderNumber="9" Mandatory="No" />

<ItemRef ItemOID="ID.AESTDT" OrderNumber="10" Mandatory="No" />

<ItemRef ItemOID="ID.AEENMON" OrderNumber="11" Mandatory="No" />

<ItemRef ItemOID="ID.AEENDAY" OrderNumber="12" Mandatory="No" />

<ItemRef ItemOID="ID.AEENYR" OrderNumber="13" Mandatory="No" />

<ItemRef ItemOID="ID.AEENDT" OrderNumber="14" Mandatory="No" />

<ItemRef ItemOID="ID.AESEV" OrderNumber="15" Mandatory="No" />

<ItemRef ItemOID="ID.AEREL" OrderNumber="16" Mandatory="No" />

<ItemRef ItemOID="ID.AEOUT" OrderNumber="17" Mandatory="No" />

<ItemRef ItemOID="ID.AEACTTRT" OrderNumber="18" Mandatory="No" />

<ItemRef ItemOID="ID.AECONTRT" OrderNumber="19" Mandatory="No" />

</ItemGroupDef>

<!-
Column attributes as defined in the table

-->
<ItemDef OID="ID.TAREA" Name="TAREA" SASFieldName="TAREA" DataType="text" Length="4" />
<ItemDef OID="ID.PNO" Name="PNO" SASFieldName="PNO" DataType="text" Length="15" />
<ItemDef OID="ID.SCTRY" Name="SCTRY" SASFieldName="SCTRY" DataType="text" Length="4" />
<ItemDef OID="ID.F_STATUS" Name="F_STATUS" SASFieldName="F_STATUS" DataType="text" Length="1" />
<ItemDef OID="ID.LINE_NO" Name="LINE_NO" SASFieldName="LINE_NO" DataType="integer" Length="2" />
<ItemDef OID="ID.AETERM" Name="AETERM" SASFieldName="AETERM" DataType="text" Length="100" />
<ItemDef OID="ID.AESTMON" Name="AESTMON" SASFieldName="AESTMON" DataType="integer" Length="2" />
<ItemDef OID="ID.AESTDAY" Name="AESTDAY" SASFieldName="AESTDAY" DataType="integer" Length="2" />
<ItemDef OID="ID.AESTYR" Name="AESTYR" SASFieldName="AESTYR" DataType="integer" Length="4" />
<ItemDef OID="ID.AESTDT" Name="AESTDT" SASFieldName="AESTDT" DataType="date" />
<ItemDef OID="ID.AEENMON" Name="AEENMON" SASFieldName="AEENMON" DataType="integer" Length="2" />
<ItemDef OID="ID.AEENDAY" Name="AEENDAY" SASFieldName="AEENDAY" DataType="integer" Length="2" />
<ItemDef OID="ID.AEENYR" Name="AEENYR" SASFieldName="AEENYR" DataType="integer" Length="4" />
<ItemDef OID="ID.AEENDT" Name="AEENDT" SASFieldName="AEENDT" DataType="date" />
<ItemDef OID="ID.AESEV" Name="AESEV" SASFieldName="AESEV" DataType="text" Length="1" />
<ItemDef OID="ID.AEREL" Name="AEREL" SASFieldName="AEREL" DataType="text" Length="1" />
<ItemDef OID="ID.AEOUT" Name="AEOUT" SASFieldName="AEOUT" DataType="text" Length="1" />
<ItemDef OID="ID.AEACTTRT" Name="AEACTTRT" SASFieldName="AEACTTRT" DataType="text" Length="1" />
<ItemDef OID="ID.AECONTRT" Name="AECONTRT" SASFieldName="AECONTRT" DataType="text" Length="1" />
</MetaDataVersion>

</Study>

<!-
Administrative metadata

-->

38 Example: Exporting a CDISC ODM XML Document with Required and Optional Statements � Chapter 4

<!-
Actual data content begins here
This section represents each data record in the table
-->
<ClinicalData StudyOID="STUDY.StudyOID" MetaDataVersionOID="v1.1.0">
<SubjectData SubjectKey="001">
<StudyEventData StudyEventOID="SE.VISIT1" StudyEventRepeatKey="1">
<FormData FormOID="FORM.AE" FormRepeatKey="1">
<ItemGroupData ItemGroupOID="IG.AE" ItemGroupRepeatKey="1">
<ItemData ItemOID="ID.TAREA" Value="ONC" />
<ItemData ItemOID="ID.PNO" Value="143-02" />
<ItemData ItemOID="ID.SCTRY" Value="USA" />
<ItemData ItemOID="ID.F_STATUS" Value="V" />
<ItemData ItemOID="ID.LINE_NO" Value="1" />
<ItemData ItemOID="ID.AETERM" Value="HEADACHE" />
<ItemData ItemOID="ID.AESTMON" Value="6" />
<ItemData ItemOID="ID.AESTDAY" Value="10" />
<ItemData ItemOID="ID.AESTYR" Value="1999" />
<ItemData ItemOID="ID.AESTDT" Value="1999-06-10" />
<ItemData ItemOID="ID.AEENMON" Value="6" />
<ItemData ItemOID="ID.AEENDAY" Value="14" />
<ItemData ItemOID="ID.AEENYR" Value="1999" />
<ItemData ItemOID="ID.AEENDT" Value="1999-06-14" />
<ItemData ItemOID="ID.AESEV" Value="1" />
<ItemData ItemOID="ID.AEREL" Value="0" />
<ItemData ItemOID="ID.AEOUT" Value="1" />
<ItemData ItemOID="ID.AEACTTRT" Value="0" />
<ItemData ItemOID="ID.AECONTRT" Value="1" />
</ItemGroupData>
<ItemGroupData ItemGroupOID="IG.AE" ItemGroupRepeatKey="2">
<ItemData ItemOID="ID.TAREA" Value="ONC" />
<ItemData ItemOID="ID.PNO" Value="143-02" />
<ItemData ItemOID="ID.SCTRY" Value="USA" />
<ItemData ItemOID="ID.F_STATUS" Value="V" />
<ItemData ItemOID="ID.LINE_NO" Value="2" />
<ItemData ItemOID="ID.AETERM" Value="CONGESTION" />
<ItemData ItemOID="ID.AESTMON" Value="6" />
<ItemData ItemOID="ID.AESTDAY" Value="11" />
<ItemData ItemOID="ID.AESTYR" Value="1999" />
<ItemData ItemOID="ID.AESTDT" Value="1999-06-11" />
<ItemData ItemOID="ID.AEENMON" IsNull="Yes" />
<ItemData ItemOID="ID.AEENDAY" IsNull="Yes" />
<ItemData ItemOID="ID.AEENYR" IsNull="Yes" />
<ItemData ItemOID="ID.AEENDT" IsNull="Yes" />
<ItemData ItemOID="ID.AESEV" Value="1" />
<ItemData ItemOID="ID.AEREL" Value="0" />
<ItemData ItemOID="ID.AEOUT" Value="2" />
<ItemData ItemOID="ID.AEACTTRT" Value="0" />
<ItemData ItemOID="ID.AECONTRT" Value="1" />
</ItemGroupData>
</FormData>
</StudyEventData>
</SubjectData>
</ClinicalData>
</ODM>

Example: Exporting a CDISC ODM XML Document with Required and

Optional Statements

Overview
This example includes required and optional PROC CDISC statements for exporting
a CDISC ODM XML document. The example illustrates how to specify metadata
attributes that are stored in SAS data sets and referenced in the DATA= argument.
CDISC Procedure Examples for CDISC ODM � Program 39

When exporting, the following requirements apply:

3 You can specify metadata attributes for the required ODM, STUDY,
GLOBALVARIABLES, and METADATAVERSION statements either directly in the
CDISC procedure statement or stored in a SAS data set.
3 Metadata attributes for the optional BASICDEFINITIONS, PRESENTATION,
USER, LOCATION, and SIGNATURE statements must be submitted in SAS data
sets referenced in the DATA= argument.
3 Optional metadata attributes for the required CLINICALDATA statement must be
speciﬁed as part of the CLINICALDATA statement syntax.

Program
First, this example uses the SAS data sets that contain metadata attributes for the
required ODM, STUDY, GLOBALVARIABLES, and METADATAVERSION statements
from “Example: Exporting a CDISC ODM XML Document with Metadata Attributes in
SAS Data Sets” on page 33.
Create additional SAS data sets that contain metadata attributes for the optional
BASICDEFINITIONS, PRESENTATION, USER, LOCATION, and SIGNATURE
statements. The LIBNAME statement assigns the libref CURRENT to the physical
location of the SAS data sets that will store the metadata attributes.

libname current ’C:\mydata\’;

data current.basic;
length TranslatedText $40.;

MeasurementOID="MU.KG";

Name="Kilogram";

Lang="en";

TranslatedText="English: Kilogram";

output;

MeasurementOID="MU.KG";

Name="Kilogram";

Lang="sp";

TranslatedText="Spanish: Kilogram";

output;

MeasurementOID="MU.LB";

Name="Pound";

Lang="en";

TranslatedText="English: Pound";

output;

MeasurementOID="MU.LB";

Name="Pound";

Lang="sp";

TranslatedText="Spanish: Libra";

output;

run;

data current.present;

length TranslatedText $40.;

PresentationOID="PRES.EN";

40 Program � Chapter 4

Lang="en";

TranslatedText="English: Presentation";

output;

PresentationOID="PRES.SP";

Lang="sp";

TranslatedText="Spanish: Presentation";

output;

run;

data current.location;
LocationOID="LOC.CDISCHome";
Name="CDISC Headquarters";
Studyoid="123-456-789";
MetadataversionOID="v1.1.0";
EffectiveDate="2001-10-19";
LocationType="Other";
output;

LocationOID="LOC.site001";
Name="Roswell Park";
StudyOID="123-456-789";
MetadataversionOID="v1.1.0";
EffectiveDate="2001-10-19";
LocationType="Site";
output;

run;

data current.user;
length usertype $20.;
length organization $40.;
UserOID="USR.cdisc001";
UserType="Other";
FullName="Fred Flintstone";
FirstName="Fred";
LastName="Flintstone";
Organization = "CDISC";
LocationOID="LOC.CDISCHome";
StreetName="123 Main Street";
City="Washington";
StateProv="DC";
Country="United States";
PostalCode="";
output;

UserOID="USR.inv001";

UserType="Investigator";

FullName="Wilma Flintstone";

FirstName="Wilma";

LastName="Flintstone";

Organization="Roswell Park";

LocationOID="LOC.site001";

StreetName="";

City="";

CDISC Procedure Examples for CDISC ODM � Program 41

StateProv="";

Country="";

PostalCode="";

output;
run;

data current.signature;
SignatureOID="SD.cdisc001-es";
Methodology="Electronic";
Meaning="Signature Meaning";
LegalReason="LegalReason";
run;

Reference the SAS data sets in a PROC CDISC program:

1 The FILENAME statement assigns the fileref XMLOUT to the physical location of
the output XML document.
2 The required PROC CDISC statement specifies CDISC ODM as the model and the
fileref XMLOUT, which references the physical location of the output XML
document.
3 The required ODM statement includes the DATA= argument to reference the SAS
data set CURRENT.ODM, which stores the CDISC ODM version and file type.
4 The required STUDY statement includes the DATA= argument to reference the
SAS data set CURRENT.STUDY, which stores the study identifier.
5 The required GLOBALVARIABLES statement includes the DATA= argument to
reference the SAS data set CURRENT.GLOBALS, which stores general summary
information about the study.
6 The optional BASICDEFINITIONS statement includes the DATA= argument to
reference the SAS data set CURRENT.BASIC, which stores information about
measurement units that are used in the study.
7 The required METADATAVERSION statement includes the DATA= argument to
reference the SAS data set CURRENT.METADATA, which stores the metadata
version and version name.
8 The optional PRESENTATION statement includes the DATA= argument to
reference the SAS data set CURRENT.PRESENT, which stores information about
how the study is presented to users.
9 The optional USER statement includes the DATA= argument to reference the SAS
data set CURRENT.USER, which stores information about users involved in the
study.
10 The optional LOCATION statement includes the DATA= argument to reference the
SAS data set CURRENT.LOCATION, which stores information about the physical
location of the study.
11 The optional SIGNATURE statement includes the DATA= argument to reference
the SAS data set CURRENT.SIGNATURE, which stores information about the
signatures required in administering the study.
12 The required CLINICALDATA statement identifies the input SAS data set, which
is CURRENT.AE. The input SAS data set contains the data content and KeySet
members that are written to the XML document. In addition, the CLINICALDATA
statement specifies optional metadata attributes.

filename xmlout ’C:\XML\aeopts.xml’; u

42 Example: Describing a CDISC ODM SAS Data Set with the CONTENTS Statement � Chapter 4

proc cdisc model=odm write=xmlout; v

odm data=current.odm; w

study data=current.study; x

globalvariables data=current.globals; y

basicdefinitions data=current.basic; U

metadataversion data=current.metadata; V

presentation data=current.present; W

user data=current.user; X

location data=current.location; at

signature data=current.signature; ak

clinicaldata data=current.ae al
domain="AE"

name = "Adverse Events"

comment = "Adverse Events in the Clinical Trial";

run;

filename xmlout clear;

Example: Describing a CDISC ODM SAS Data Set with the CONTENTS
Statement

Overview
This example illustrates how to list the attributes of a CDISC ODM SAS data set in
the CDISC ODM XML document named AE.XML. The output displays in the SAS log.
The example includes two different programs, which illustrate how the ODM
statement LONGNAMES= processing option determines the sources of captured SAS
names parameters based on the value of the option.
To view the AE.XML document, see “Sample CDISC ODM XML Document” on page
81.

Program with LONGNAMES=NO

The following SAS program lists the attributes of a CDISC ODM SAS data set by
using the ODM statement LONGNAMES=NO processing option:
1 The FILENAME statement assigns the fileref XMLINP to the physical location of
the input XML document (complete pathname, filename, and file extension).
2 The PROC CDISC statement specifies CDISC ODM as the model and the fileref
XMLINP, which references the physical location of the input XML document to be
imported.
CDISC Procedure Examples for CDISC ODM � Program with LONGNAMES=NO 43

3 The ODM statement speciﬁes CDISC ODM version 1.2 and the
LONGNAMES=NO processing option, which determines the following:
3 ODM name attributes are converted to SAS names that can be a maximum of
eight characters in length.
3 The SAS data set name is captured from the SASDatasetName= attribute in
the ODM ItemGroupDef element. SAS variable names are captured from the
SASFieldName= attribute in ODM ItemDef elements. SAS format names are
captured from the SASFormatName= attribute in ODM CodeList elements.

4 The CONTENTS statement writes the contents of the CDISC ODM SAS data set
in the SAS log. Note that the CONTENTS statement must specify the name that
is in the SASDatasetName= attribute in the ODM ItemGroupDef element.
filename xmlinp ’C:\XML\ae.xml’; u

proc cdisc model=odm read=xmlinp; v

odm odmversion="1.2" longnames=no; w
contents table="AE"; x
run;
44 Output with LONGNAMES=NO � Chapter 4

Output with LONGNAMES=NO

Contents of CDISC ODM Table

Name AE
Libref XMLINP
ODM Version 1.2
AsOfDateTime 2009-03-31T14:01:41
CreationDateTime 2009-03-31T14:01:41
SourceSystem
SourceSystemVersion

Engine/Host Dependent Information

OID IG.AE
Name Adverse Events
SASDatasetName AE
IsReferenceData
Repeating Yes
Domain AE
Origin
Role
Purpose
Comment Some adverse events from this trial

List of Variables and Attributes

# Variable Datatype Length SigDig Format Label

1 AECONTRT string 1
2 AEACTTRT string 1
3 AEOUT string 1
4 AEREL string 1
5 AESEV string 1
6 AEENDT date DATE
7 AEENYR integer 4
8 AEENDAY integer 2
9 AEENMON integer 2
10 AESTDT date DATE
11 AESTYR integer 4
12 AESTDAY integer 2
13 AESTMON integer 2
14 AETERM string 100
15 LINE_NO integer 2
16 F_STATUS string 1
17 SCTRY string 4
18 PNO string 15
19 TAREA string 4

Program with LONGNAMES=YES

The following SAS program lists the attributes of a CDISC ODM SAS data set by
using the ODM statement LONGNAMES=YES processing option:
1 The FILENAME statement assigns the fileref XMLINP to the physical location of
the input XML document (complete pathname, filename, and file extension).
2 The PROC CDISC statement specifies CDISC ODM as the model and the fileref
XMLINP, which references the physical location of the input XML document to be
imported.
3 The ODM statement specifies CDISC ODM version 1.2 and the

LONGNAMES=YES processing option, which determines the following:

3 ODM name attributes are converted to SAS names that can be a maximum of
32 characters in length.
CDISC Procedure Examples for CDISC ODM � Output with LONGNAMES=YES 45

3 The SAS data set name, SAS variable names, and SAS format names are
captured from the Name= attribute in the ODM ItemGroupDef, ItemDef, and
CodeList elements.

4 The CONTENTS statement writes the contents of the CDISC ODM SAS data set
in the SAS log. Note that the CONTENTS statement must specify the name that
is in the Name= attribute in the ODM ItemGroupDef element.
filename xmlinp ’C:\XML\ae.xml’; u

proc cdisc model=odm v read=xmlinp;

odm odmversion="1.2" longnames=yes; w
contents table="Adverse_Events"; x
run;

Output with LONGNAMES=YES

Contents of CDISC ODM Table

Name Adverse_Events
Libref XMLINP
ODM Version 1.2
AsOfDateTime 2009-03-31T14:01:41
CreationDateTime 2009-03-31T14:01:41
SourceSystem
SourceSystemVersion

Engine/Host Dependent Information

OID IG.AE
Name Adverse Events
SASDatasetName AE
IsReferenceData
Repeating Yes
Domain AE
Origin
Role
Purpose
Comment Some adverse events from this trial

List of Variables and Attributes

# Variable Datatype Length SigDig Format Label

1 Actions_taken__other string 1
2 Actions_taken_re_study_drug string 1
3 Outcome string 1
4 Relationship_to_study_drug string 1
5 Severity string 1
6 Derived_Stop_Date date DATE
7 Stop_Year___Enter_Four_Digit_Yea integer 4
8 Stop_Day___Enter_Two_Digits_01_3 integer 2
9 Stop_Month___Enter_Two_Digits_01 integer 2
10 Derived_Start_Date date DATE
11 Start_Year___Enter_Four_Digit_Ye integer 4
12 Start_Day___Enter_Two_Digits_01_ integer 2
13 Start_Month___Enter_Two_Digits_0 integer 2
14 Conmed_Indication string 100
15 Line_Number integer 2
16 Record_status__5_levels__interna string 1
17 Country string 4
18 Protocol_Number string 15
19 Therapeutic_Area string 4
46 Example: Listing a Directory with the DATASETS Statement � Chapter 4

Example: Listing a Directory with the DATASETS Statement

Overview
This example illustrates how to produce a directory listing in the SAS log of a CDISC
ODM XML document. The output lists the name of the CDISC ODM SAS data set that
is in the XML document named AE.XML. The output also lists the attributes of the
XML document, such as ODM version and date of creation.
The example includes two different programs, which illustrate how the ODM
statement LONGNAMES= processing option determines the sources of captured SAS
names based on the value of the option.
To view the AE.XML document, see “Sample CDISC ODM XML Document” on page
81.

Program with LONGNAMES=NO

The following SAS program produces a directory listing by using the ODM statement
LONGNAMES=NO processing option:
1 The FILENAME statement assigns the fileref XMLINP to the physical location of
the input XML document (complete pathname, filename, and file extension).
2 The PROC CDISC statement specifies CDISC ODM as the model and the fileref
XMLINP, which references the physical location of the input XML document to be
imported.
3 The ODM statement specifies CDISC ODM version 1.2 and the

LONGNAMES=NO processing option, which determines the following:

3 ODM name attributes are converted to SAS names that can be a maximum of
eight characters in length.
3 The SAS data set name is captured from the SASDatasetName= attribute in
the ODM ItemGroupDef element.

4 The DATASETS statement produces a directory listing of the XML document in

the SAS log.
filename xmlinp ’C:\XML\ae.xml’; u

proc cdisc model=odm read=xmlinp; v

odm odmversion="1.2" longnames=no;w

datasets; x

run;
CDISC Procedure Examples for CDISC ODM � Program with LONGNAMES=YES 47

Output with LONGNAMES=NO

Output 4.7 Directory Listing of the AE.XML Document in the SAS Log

Directory of CDISC ODM Tables

Libref XMLINP
ODM Version 1.2
AsOfDateTime 2009-03-31T14:01:41
CreationDateTime 2009-03-31T14:01:41
SourceSystem
SourceSystemVersion

# Tablename

1 AE

Program with LONGNAMES=YES

The following SAS program produces a directory listing by using the ODM statement
LONGNAMES=YES processing option:
1 The FILENAME statement assigns the fileref XMLINP to the physical location of
the input XML document (complete pathname, filename, and file extension).
2 The PROC CDISC statement specifies CDISC ODM as the model and the fileref
XMLINP, which references the physical location of the input XML document to be
imported.
3 The ODM statement specifies CDISC ODM version 1.2 and the

LONGNAMES=YES processing option, which determines the following:

3 ODM name attributes are converted to SAS names that can be a maximum of
32 characters in length.
3 The SAS data set name is captured from the Name= attribute in the ODM
ItemGroupDef element.

4 The DATASETS statement produces a directory listing of the XML document in

the SAS log.

filename xmlinp ’C:\XML\ae.xml’; u

proc cdisc model=odm read=xmlinp; v

odm odmversion="1.2" longnames=yes;w

datasets; x

run;
48 Output with LONGNAMES=YES � Chapter 4

Output with LONGNAMES=YES

Output 4.8 Directory Listing of the AE.XML Document in the SAS Log

Directory of CDISC ODM Tables

Libref XMLINP
ODM Version 1.2
AsOfDateTime 2009-03-31T14:01:41
CreationDateTime 2009-03-31T14:01:41
SourceSystem
SourceSystemVersion

# Tablename

1 Adverse_Events
49

CHAPTER

5
CDISC Procedure Examples for
CDISC SDTM

Example: Validating CDISC SDTM Data in a SAS Data Set 49

Overview 49
Program 49
Output 50
Example: Validating CDISC SDTM Data in an Oracle Table 50
Overview 50
Program 50

Example: Validating CDISC SDTM Data in a SAS Data Set

Overview
This example validates CDISC SDTM data that is stored in a SAS data set.

Program
The following SAS program validates CDISC SDTM data that is stored in the SAS
data set RESULTS.AE:
1 The LIBNAME statement assigns the libref RESULTS to the physical location of
the input SAS data set to be validated.
2 The PROC CDISC statement specifies CDISC SDTM as the model.
3 The SDTM statement specifies the SDTM version number.
4 The DOMAINDATA statement specifies the SAS data set to be validated, the
two-character domain code, and the domain model type.
libname results ’C:\Myfiles\’; u

proc cdisc model=sdtm; v

sdtm sdtmversion="3.1"; w
domaindata data=results.AE domain=ae category=events; x
run;

libname results clear;

50 Output � Chapter 5

Output
Output 5.1 SAS Log Output

21 proc cdisc model=sdtm;

22 sdtm sdtmversion="3.1";

23 domaindata data=results.ae domain=ae category=events;

24 run;

ERROR: Required parameters not contained on DOMAINDATA(Domain=AE) statement.

Required parameter STUDYID not present.
Required parameter DOMAIN not present.
Required parameter USUBJID not present.
Required parameter AESEQ not present.
Required parameter AEDECOD not present.
NOTE: The SAS System stopped processing this step because of errors.
NOTE: PROCEDURE CDISC used (Total process time):
real time 0.00 seconds
cpu time 0.00 seconds

Example: Validating CDISC SDTM Data in an Oracle Table

Overview
This example validates CDISC SDTM data that is stored in an Oracle table.

Program
The following SAS program validates CDISC SDTM data that is stored in an Oracle
table named AE:
1 The LIBNAME statement for the SAS/ACCESS Interface to Oracle engine assigns
the libref ORALIB to the physical location of the Oracle database that contains the
Oracle table.
2 The PROC CDISC statement specifies CDISC SDTM as the model.
3 The SDTM statement specifies the SDTM version number.
4 The DOMAINDATA statement specifies the Oracle table to be validated, the

two-character domain code, and the domain model type.

libname oralib oracle user=myuser pw=mypw

path=ora_dbms preserve_tab_names=yes

connection=sharedread schema=myschema; u

proc cdisc model=sdtm; v

sdtm sdtmversion="3.1"; w

domaindata data=oralib.AE domain=ae category=events; x

run;

libname oralib clear;

3
P A R T

Procedure Reference
Chapter 6. . . . . . . . . . CDISC Procedure for CDISC ODM 53

Chapter 7 . . . . . . . . . . CDISC Procedure for CDISC SDTM 75

CHAPTER

6
CDISC Procedure for CDISC ODM

Overview: CDISC Procedure for CDISC ODM 53

Syntax: CDISC Procedure for CDISC ODM 53

PROC CDISC Statement for CDISC ODM 55

ODM Statement 57

STUDY Statement 63

GLOBALVARIABLES Statement 64

BASICDEFINITIONS Statement 65

METADATAVERSION Statement 66

PRESENTATION Statement 66

USER Statement 67

LOCATION Statement 70

SIGNATURE Statement 71

CLINICALDATA Statement 71

CONTENTS Statement 73

DATASETS Statement 74

Overview: CDISC Procedure for CDISC ODM

PROC CDISC imports and exports XML documents that conform to CDISC ODM
version 1.2.

Syntax: CDISC Procedure for CDISC ODM

Restriction:
PROC CDISC is supported in the following operating environments:
Windows, UNIX, and z/OS.

Restriction:
PROC CDISC supports only one CDISC model and one CLINICALDATA

statement per invocation.

Restriction: PROC CDISC does not support vendor extensions to CDISC ODM.

Tip: PROC CDISC statements are listed in CDISC ODM markup order.

PROC CDISC MODEL=ODM

READ=fileref |WRITE=fileref
< FORMATACTIVE= NO | YES >
< FORMATNOREPLACE= NO | YES>
<FORMATLIBRARY=libref>
< LANGUAGE=language-identifier> ;
54 Syntax: CDISC Procedure for CDISC ODM � Chapter 6

ODM <processing-options> metadata-attributes |

<processing-options> DATA=libref.member-name ;
STUDY metadata-attributes | DATA=libref.member-name ;
GLOBALVARIABLES metadata-attributes | DATA=libref.member-name ;
<BASICDEFINITIONS DATA=libref.member-name> ;
METADATAVERSION metadata-attributes | DATA=libref.member-name ;
<PRESENTATION DATA=libref.member-name> ;
<USER DATA=libref.member-name> ;
<LOCATION DATA=libref.member-name> ;
<SIGNATURE DATA=libref.member-name> ;
CLINICALDATA
OUT=libref.member-name SASDATASETNAME="name" |
DATA=libref.member-name <metadata-attributes> ;

CONTENTS TABLE="name";

DATASETS;

The following table provides a quick reference that indicates the required and
optional statements for importing and exporting a CDISC ODM XML document:

Table 6.1 Statements for Importing and Exporting a CDISC ODM XML Document

Statement Description Importing Exporting

PROC CDISC Speciﬁes CDISC ODM as the model required required

and references the physical location
of the input or output XML
document.

ODM Speciﬁes the CDISC ODM version required required

number and file type.
STUDY Specifies the study identifier. not valid required

GLOBALVARIABLES Speciﬁes general summary not valid required

information about the study.

BASICDEFINITIONS Speciﬁes information about not valid optional

measurement units that are used
in the study.

METADATAVERSION Speciﬁes the metadata version and not valid required

version name that are used by the
study.

PRESENTATION Speciﬁes information about how not valid optional

the study is presented to users.

USER Speciﬁes information about users not valid optional

involved in the study.

LOCATION Speciﬁes information about the not valid optional

physical location of the study.
SIGNATURE Speciﬁes information about the not valid optional
signatures required in
administering the study.
CDISC Procedure for CDISC ODM � PROC CDISC Statement for CDISC ODM 55

Statement Description Importing Exporting

CLINICALDATA When importing, identiﬁes the required required

output SAS data set and speciﬁes
where the data content in the XML
document begins; when exporting,
identiﬁes the input SAS data set
and optional metadata attributes.

CONTENTS Describes the contents of a CDISC optional not valid

ODM SAS data set in the SAS log.

DATASETS Produces a directory listing of the optional not valid

CDISC ODM XML document in the
SAS log.

PROC CDISC Statement for CDISC ODM

Speciﬁes CDISC ODM as the model and references the physical location of the input or output
ODM XML document.
Requirement: Required for both importing and exporting.

PROC CDISC MODEL=ODM

READ=ﬁleref |WRITE=ﬁleref

<FORMATACTIVE= NO | YES >

<FORMATNOREPLACE= NO | YES>

< FORMATLIBRARY=libref>

<LANGUAGE=language-identiﬁer> ;

Arguments

MODEL=ODM
speciﬁes CDISC ODM as the model.

Requirement: Required for both importing and exporting.

Interaction: The model speciﬁcation determines the syntax for the PROC CDISC

statement and subsequent procedure statements. Specifying MODEL=ODM

requires that you specify either the READ= or WRITE= argument and that the
next statement must be the ODM statement.
READ=fileref
specifies the SAS fileref that is assigned to the input XML document.
Requirement: Required for importing.
WRITE=fileref
specifies the SAS fileref that is assigned to the output XML document.
Requirement: Required for exporting.
FORMATACTIVE=NO | YES
specifies whether the content in the CDISC ODM CodeList element, which includes
instructions for transcoding display data in an XML document, is to be converted to
PROC FORMAT style formats or SAS formats, and vice versa.
56 PROC CDISC Statement for CDISC ODM � Chapter 6

For both importing and exporting, FORMATACTIVE=NO causes formats to be

ignored. This is the default.
For importing, FORMATACTIVE=YES does the following:
3 Converts CDISC ODM CodeList content to the corresponding SAS format, or
creates PROC FORMAT style formats from the CodeList content.
3 Registers the SAS formats in the referenced variables.
3 Stores the created SAS formats in the SAS FORMAT library.
For exporting, FORMATACTIVE=YES converts SAS formats to the corresponding
CDISC ODM CodeList content and variable references.
Default: NO
Requirement: Optional for both importing and exporting.
Interaction: (Optional) If you specify FORMATACTIVE=YES, then you can specify
FORMATNOREPLACE= and FORMATLIBRARY=.
FORMATNOREPLACE=NO | YES
specifies whether to replace existing SAS formats in the FORMAT catalog when an
existing SAS format has the same name as a format that is being converted by PROC
CDISC.
When FORMATNOREPLACE=NO, the procedure replaces existing SAS formats
that have the same name. This is the default.
When FORMATNOREPLACE=YES, the procedure does not replace existing SAS
formats that have the same name.
Default: NO
Requirement: Optional for importing.
Interaction: Ignored unless FORMATACTIVE=YES.
FORMATLIBRARY=libref
specifies the assigned libref of an existing SAS library in which to create the
FORMAT catalog, which is a permanent storage location for variable formats that
are created by PROC CDISC.
Requirement: Optional for importing.
Interaction: Ignored unless FORMATACTIVE=YES.
LANGUAGE="language-identifier"
specifies a language identifier for the language tag attribute (xml:lang) in the ODM
TranslatedText elements.
3 When importing, PROC CDISC locates the specified language identifier in the
ODM TranslatedText element, and creates a SAS format by using the
TranslatedText items with a matching language tag attribute. The created SAS
format is then applied to the data that is imported from the XML document.
3 When exporting, PROC CDISC uses the specified language identifier as the
language tag attribute value in the ODM TranslatedText element.
A language identifier, as defined in the XML specification, can be one of the

following:

3 A two-letter language code as defined by ISO 639, "Codes for the representation
of names of languages."
3 A language identifier that has been registered with the Internet Assigned
Numbers Authority (IANA). The language identifier begins with the prefix i- or
I-.
3 A language identifier that has been assigned by the user or agreed on between
parties in private use. The language identifier begins with the prefix x- or X- to
CDISC Procedure for CDISC ODM � ODM Statement 57

ensure that it does not conflict with names that are later standardized or
registered with IANA.
Enclose the language identifier in single or double quotation marks.
Requirement: Optional for both importing and exporting.
Featured in: “Example: Importing a CDISC ODM XML Document Using a
Language Identifier” on page 21

ODM Statement
Specifies the CDISC ODM version number and file type.
Restriction:
Processing options must be specified in the statement. They cannot be stored

in a SAS data set. Only metadata attributes can be stored in a SAS data set.

Requirement: Required for both importing and exporting.

Tip:You can specify metadata attributes either directly in the ODM statement or store

them in a SAS data set that you reference in the DATA= argument.

ODM <processing-options> metadata-attributes |

<processing-options> DATA=libref.member-name ;

Arguments

processing-options
specifies options that affect how KeySet members are processed.
LONGNAMES=NO | YES
determines the sources of captured SAS name parameters, and controls the
maximum length of SAS names that is valid.
NO
When importing, specifies that ODM name attributes are converted to SAS
names that can be a maximum length of eight characters. PROC CDISC
captures the SAS data set name from the SASDatasetName= attribute in the
ODM ItemGroupDef element. SAS variable names are captured from the
SASFieldName= or SDSVarName= attribute in ODM ItemDef elements. SAS
format names are captured from the SASFormatName= attribute in ODM
CodeList elements. If these optional ODM attributes are not available, then the
Name= attribute (which is required in the individual ODM elements) is used.
When exporting, specifies that SAS names are converted to ODM name
attributes that can be a maximum length of eight characters. PROC CDISC
exports the SAS data set name to the SASDatasetName= attribute in the ODM
ItemGroupDef element. SAS variable names are exported to the
SASFieldName= in ODM ItemDef elements. SAS format names are exported to
the SASFormatName= attribute in ODM CodeList elements. The required
ODM Name= attribute is a duplicate of the SAS name attribute value.
For example, by using the “Sample CDISC ODM XML Document” on page 81,
LONGNAMES=NO imports the SAS data set name AE from the
SASDatasetName= attribute in the ODM ItemGroupDef element.
58 ODM Statement � Chapter 6

Requirement: When importing, values for the ODM elements must be valid
SAS names. Except for in the Name= attribute, an invalid SAS name
generates an error because it does not conform to the ODM schema.
Interaction: PROC CDISC behavior with LONGNAMES=NO is compatible
with legacy data before Version 7, which includes Version 5 transport files.
YES
When importing, specifies that ODM name attributes are converted to SAS
names that can be a maximum length of 32 characters. PROC CDISC captures
the SAS data set name, SAS variable names, and SAS format names from the
Name= attribute in the ODM ItemGroupDef, ItemDef, and CodeList elements.
The optional SASDatasetName=, SASFieldName=, SDSVarName=, and
SASFormatName= attributes (used with LONGNAMES=NO) are ignored even
if they are available in the ODM elements.
When exporting, specifies that SAS names are converted to ODM name
attributes that can be a maximum length of 32 characters. PROC CDISC
exports the SAS data set name, SAS variable names, and SAS format names as
values for the Name= attribute in the ODM ItemGroupDef, ItemDef, and
CodeList elements.
For example, by using the “Sample CDISC ODM XML Document” on page 81,
LONGNAMES=YES imports the SAS data set name Adverse_Events from the
Name= attribute in the ODM ItemGroupDef element.
Interaction: PROC CDISC behavior with LONGNAMES=YES is compatible
with Version 7 and later. The behavior is not compatible with Version 5
transport files.
Interaction: When importing, if a Name= attribute value is not a valid SAS
name, PROC CDISC converts it to a valid SAS name. For example, a blank
space or any other invalid character in the field is replaced with an
underscore. Truncation occurs if the Name= attribute value exceeds the
maximum length.
Default: NO
Requirement: Optional for both importing and exporting.
Tip: The SASDatasetName=, SASFieldName= or SDSVarName=, and
SASFormatName= ODM elements are optional in CDISC ODM version 1.2.
However, the Name= attribute for those ODM elements is required.
See also: “CDISC ODM KeySet Members” on page 6
ODMMAXIMUMOIDLENGTH=number
specifies a character length for the CDISC ODM KeySet members. The default
value is the OID length that is defined in CDISC ODM. The maximum OID length
that PROC CDISC accepts is 100 characters.
Requirement: Optional for importing.
See also: “CDISC ODM KeySet Members” on page 6
Featured in: “Example: Importing a CDISC ODM XML Document Specifying
KeySet Processing Options” on page 19
ODMMINIMUMKEYSET=NO | YES
specifies whether to limit the CDISC ODM KeySet members that are in the study
data.

NO
When importing, speciﬁes that all KeySet members are written to the output
SAS data set. Note that ODMMINIMUMKEYSET=NO increases the row size
10 times the maximum OID length that is deﬁned in CDISC ODM.
CDISC Procedure for CDISC ODM � ODM Statement 59

When exporting, specifies that all KeySet members that are in the input SAS
data set are written to the output XML document.
YES
When importing, specifies that only the SubjectKey is written to the output SAS
data set.
When exporting, specifies that only the SubjectKey that is in the input SAS
data set is written to the output XML document. Other KeySet members are
from PROC CDISC statements or are automatically generated by PROC CDISC.
Default: NO
Requirement: Optional for both importing and exporting.
See also: “CDISC ODM KeySet Members” on page 6
Featured in: “Example: Importing a CDISC ODM XML Document Using Default
KeySet Processing” on page 16 and “Example: Importing a CDISC ODM XML
Document Specifying KeySet Processing Options” on page 19
ORDERNUMBER=YES | NO
determines whether PROC CDISC validates OrderNumber attributes in ItemRef
elements. OrderNumber attributes define an order among related entities by using
consecutive integer values.

YES
speciﬁes to validate OrderNumber attributes. If an element contains
OrderNumber attributes that do not conform to CDISC ODM, such as missing
or out-of-sequence integers, PROC CDISC displays warnings in the SAS log.
Alias: USE
NO
speciﬁes to ignore OrderNumber attributes. Warnings are not displayed in the
SAS log.
Alias: IGNORE

Default: YES

Requirement: Optional for importing.

Featured in: “Example: Importing a CDISC ODM XML Document with

OrderNumber Attributes” on page 27

USENAMEASLABEL=NO | YES
determines the sources of captured SAS data set and variable labels. Labels can
be a maximum of 200 characters.
NO
When importing, speciﬁes that ODM comment attributes are converted to SAS
labels. PROC CDISC imports the SAS data set label from the Comment=
attribute in the ODM ItemGroupDef element, and SAS variable labels from the
Comment= attribute in the ODM ItemDef elements.
When exporting, speciﬁes that SAS labels are converted to ODM comment
attributes. PROC CDISC exports the SAS data set label to the Comment=
attribute in the ODM ItemGroupDef element, and SAS variable labels to the
Comment= attribute in the ODM ItemDef elements.
60 ODM Statement � Chapter 6

YES
When importing, speciﬁes that ODM name attributes are converted to SAS
labels. The value of the LONGNAMES= option determines the sources of the
captured SAS data set and variable labels:

LONGNAMES=NO
PROC CDISC imports the SAS data set label from the SASDatasetName=
attribute in the ODM ItemGroupDef element, and SAS variable labels from
the SASFieldName= or SDSVarName= attribute in ODM ItemDef elements.
If these optional ODM attributes are not available, then the Name= attribute
(which is required in the individual ODM elements) is used.
LONGNAMES=YES
PROC CDISC imports the SAS data set label from the Comment= attribute
in the ODM ItemGroupDef element, and SAS variable labels from the
Comment= attribute in the ODM ItemDef elements.
Restriction: Specifying USENAMEASLABEL=YES and LONGNAMES=YES
are mutually exclusive.
When exporting, speciﬁes that SAS labels are converted to ODM name
attributes. The value of the LONGNAMES= option determines the sources of
the captured SAS data set and variable labels:

LONGNAMES=NO
PROC CDISC exports the SAS data set label to the SASDatasetName=
attribute in the ODM ItemGroupDef element, and SAS variable labels to the
SASFieldName= in ODM ItemDef elements. The required ODM Name=
attribute is a duplicate of the SAS name attribute value.
LONGNAMES=YES
PROC CDISC exports the SAS data set label to the Comment= attribute in
the ODM ItemGroupDef element, and SAS variable labels to the Comment=
attribute in the ODM ItemDef elements.
Restriction: Specifying USENAMEASLABEL=YES and LONGNAMES=YES
are mutually exclusive.
Default: NO
Requirement: Optional for both importing and exporting.
Tip: The Comment= attribute in the ODM ItemGroupDef and ItemDef elements is
optional in CDISC ODM version 1.2. However, the Name= attribute for those
ODM elements is required.
metadata-attributes
includes the following syntax, which can be speciﬁed directly in the ODM statement
or stored in a SAS data set that you reference in the DATA= argument:
Restriction: You cannot store some metadata attributes in a SAS data set, and also
specify other metadata attributes in the ODM statement. If you use a SAS data
set, you must store all metadata attributes in the SAS data set.
ODMVERSION="version-number"
speciﬁes the CDISC ODM version number. The valid value is 1.2. Enclose the
version number in single or double quotation marks.
Requirement: Required for both importing and exporting.
Restriction: PROC CDISC does not support CDISC ODM versions before 1.2.
CDISC ODM versions 1.1 and 1.0 are not supported. However, CDISC ODM
CDISC Procedure for CDISC ODM � ODM Statement 61

version 1.2.1 is semantically equivalent to version 1.2 and should be speciﬁed as

simply 1.2.
FILEOID="identifier"
specifies a unique identifier for the exported XML document. Enclose the identifier
in single or double quotation marks.
Requirement: Required for exporting.
FILETYPE=SNAPSHOT | TRANSACTIONAL
specifies the XML document file type, which defines the type of data that the XML
document contains.
Requirement: Required for exporting.

SNAPSHOT
specifies an XML document that contains only the current state of the data and
metadata that it describes, with no transactional history.
TRANSACTIONAL
specifies an XML document that contains the current state of the data and
metadata, with transactional history. A transactional XML document supports
more than one instruction per data point.
Requirement: The input SAS data set that you are exporting must contain the
required data. If you specify TRANSACTIONAL, the transactional history
must be in the SAS data set.
DESCRIPTION="string"
specifies a text string that provides details to supplement the other attributes that
are described in the XML document. Enclose the string in single or double
quotation marks.
Requirement: Optional for exporting.
GRANULARITY=ALL | METADATA | ADMINDATA | REFERENCEDATA |
ALLCLINICALDATA | SINGLESITE | SINGLESUBJECT
describes the scope of information in the XML document.
Requirement: Optional for exporting.
Interaction: PROC CDISC does not generate output that is based on the specified
value of GRANULARITY=.

ALL

indicates any and all types of data and metadata.

METADATA

indicates only metadata.

ADMINDATA
indicates the AdminData element, which is administrative data about users,
locations, and electronic signatures.
REFERENCEDATA
indicates the ReferenceData element, which is reference data that provides
information about how to interpret clinical data.
ALLCLINICALDATA

indicates all clinical data.

SINGLESITE

indicates clinical data for a single site.

62 ODM Statement � Chapter 6

SINGLESUBJECT

indicates clinical data for a single subject.

ARCHIVAL=YES
when FILETYPE=TRANSACTIONAL, indicates whether the XML document
should meet the requirements of an electronic record as deﬁned in the FDA 21
CFR Part 11 standard.
Requirement: Optional for exporting.

CREATIONDATETIME="datetime-value"
speciﬁes the date and time when the XML document was created or transmitted,
in compliance with ISO 8601 guidelines. Enclose the value in single or double
quotation marks.
Requirement: Optional for exporting.

PRIORFILEOID="name"
speciﬁes a reference to the previous XML document (if any) in a series. Enclose
the name in single or double quotation marks.
Requirement: Optional for exporting.

ASOFDATETIME="datetime-value"
speciﬁes the date and time when the source database was queried to create the
XML document, in compliance with ISO 8601 guidelines. Enclose the value in
single or double quotation marks.
Requirement: Optional for exporting.

ORIGINATOR="name"
identiﬁes the organization that generated the XML document. Enclose the name
in single or double quotation marks.
Requirement: Optional for exporting.

SOURCESYSTEM="string"
speciﬁes the application that created or transmitted the XML document. The
default value is the short name of the current SAS release (for example, SAS 9.2).
Enclose the string in single or double quotation marks.
Requirement: Optional for exporting.

SOURCESYSTEMVERSION="string"
speciﬁes the version of the application that created or transmitted the XML
document. The default value is the annotated name of the SAS release (for
example, 9.01.01MxPmmddyyyy). Enclose the string in single or double quotation
marks.
Requirement: Optional for exporting.

DATA=libref.member-name
speciﬁes the SAS data set that contains the metadata attributes. The libref, which is
assigned with the LIBNAME statement, is an alias for the data storage location
where member-name is stored.
The following table lists processing options and CDISC ODM metadata attributes
that are available for importing or exporting, and whether they can be stored in a SAS
data set.
CDISC Procedure for CDISC ODM � STUDY Statement 63

Table 6.2 ODM Statement Syntax Quick Reference

Syntax Importing Exporting Stored in SAS

Data Set
LONGNAMES=NO|YES optional optional no

ODMMAXIMUMOIDLENGTH= optional not valid no

ODMMINIMUMKEYSET=NO|YES optional optional no

ORDERNUMBER=YES | NO optional not valid no

USENAMEASLABEL=NO|YES optional optional no

ODMVERSION= required required yes

FILEOID= not valid required yes

FILETYPE= not valid required yes

DESCRIPTION= not valid optional yes

GRANULARITY= not valid optional yes

ARCHIVAL=YES not valid optional yes

CREATIONDATETIME= not valid optional yes

PRIORFILEOID= not valid optional yes

ASOFDATETIME= not valid optional yes

ORIGINATOR= not valid optional yes

SOURCESYSTEM= not valid optional yes

SOURCESYSTEMVERSION= not valid optional yes

STUDY Statement
Speciﬁes the study identiﬁer.
Requirement: Required for exporting.

Tip: You can specify the metadata attribute either directly in the STUDY statement or

store it in a SAS data set that you reference in the DATA= argument.

STUDY metadata-attribute | DATA=libref.member-name ;

Arguments

metadata-attribute
includes the following syntax, which can be specified directly in the STUDY
statement or stored in a SAS data set that you reference in the DATA= argument:
STUDYOID="ODM-identifier"
specifies a unique identifier for the study, which overrides the __STUDYOID
variable in the input SAS data set. Enclose the identifier in single or double
64 GLOBALVARIABLES Statement � Chapter 6

quotation marks. A string of characters up to the maximum OID length that is

deﬁned in CDISC ODM is supported.
Requirement: Required.

DATA=libref.member-name
speciﬁes the SAS data set that contains the metadata attribute. The libref, which is
assigned with the LIBNAME statement, is an alias for the data storage location
where member-name is stored.

GLOBALVARIABLES Statement
Speciﬁes general summary information about the study.
Requirement: Required for exporting.
Tip: You can specify metadata attributes either directly in the GLOBALVARIABLES
statement or store them in a SAS data set that you reference in the DATA= argument.

GLOBALVARIABLES metadata-attributes | DATA=libref.member-name ;

Arguments

metadata-attributes
includes the following syntax, which can be speciﬁed directly in the
GLOBALVARIABLES statement or stored in a SAS data set that you reference in the
DATA= argument:
Restriction: You cannot store some metadata attributes in a SAS data set, and also
specify other metadata attributes in the GLOBALVARIABLES statement. If you
use a SAS data set, you must store all metadata attributes in the SAS data set.
STUDYNAME="name"
speciﬁes the short external name of the study. Enclose the name in single or
double quotation marks.
Requirement: Required.

STUDYDESCRIPTION="string"
speciﬁes a description of the study. Enclose the string in single or double quotation
marks.
Requirement: Required.

PROTOCOLNAME="name"
speciﬁes the sponsor’s internal name for the protocol. Enclose the name in single
or double quotation marks.
Requirement: Required.

BASICDEFINITIONS Statement
Speciﬁes information about measurement units that are used in the study.

Requirement: Optional for exporting.

Requirement:
Metadata attributes must be stored in a SAS data set that you reference in
the DATA= argument. You cannot specify metadata attributes in the
BASICDEFINITIONS statement.

BASICDEFINITIONS DATA=libref.member-name ;

Arguments

MEASUREMENTOID="ODM-identifier"
specifies a symbol or abbreviation that represents a measurement unit. Enclose
the identifier in single or double quotation marks. A string of characters up to the
maximum OID length that is defined in CDISC ODM is supported.
Requirement: Required.

NAME="name"
speciﬁes the name of the measurement unit. Enclose the name in single or double
quotation marks.
Requirement: Required.

3 A two-letter language code as deﬁned by ISO 639, "Codes for the

representation of names of languages."
3 A language identifier that has been registered with the IANA. The language
identifier begins with the prefix i- or I-.
3 A language identifier that has been assigned by the user or agreed on
between parties in private use. The language identifier must begin with the
prefix x- or X- to ensure that it does not conflict with names that are later
standardized or registered with IANA.

Enclose the language identiﬁer in single or double quotation marks.

66 METADATAVERSION Statement � Chapter 6

TRANSLATEDTEXT="string"
speciﬁes the name of the measurement unit in the speciﬁed language. Enclose the
string in double or single quotation marks.
Requirement: Required.

METADATAVERSION Statement
Speciﬁes the metadata version and version name that are used by the study.

Requirement: Required for exporting.

Tip: You can specify metadata attributes either directly in the METADATAVERSION

statement or store them in a SAS data set that you reference in the DATA= argument.

METADATAVERSION metadata-attributes | DATA=libref.member-name ;

Arguments

metadata-attributes
includes the following syntax, which can be specified directly in the
METADATAVERSION statement or stored in a SAS data set that you reference in
the DATA= argument:
Restriction: You cannot store some metadata attributes in a SAS data set, and also
specify other metadata attributes in the METADATAVERSION statement. If you
use a SAS data set, you must store all metadata attributes in the SAS data set.
METADATAVERSIONOID="name"
specifies the metadata version that is used by the study. Enclose the name in
single or double quotation marks.
Requirement: Required.
NAME="name"
specifies a name for the metadata version. Enclose the name in single or double
quotation marks.
Requirement: Required.
DATA=libref.member-name
specifies the SAS data set that contains the metadata attributes. The libref, which is
assigned with the LIBNAME statement, is an alias for the data storage location
where member-name is stored.

PRESENTATION Statement
Speciﬁes information about how the study is presented to users.
Requirement:
Optional for exporting.
Requirement:
Metadata attributes must be stored in a SAS data set that you reference in
the DATA= argument. You cannot specify metadata attributes in the PRESENTATION
statement.
CDISC Procedure for CDISC ODM � USER Statement 67

PRESENTATION DATA=libref.member-name ;

Arguments

LANGUAGE="language-identifier"
specifies a language identifier. Enclose the identifier in single or double quotation
marks.
Requirement: Required.
A language identifier, as defined in the XML specification, can be one of the
following:
3 A two-letter language code as defined by ISO 639, "Codes for the
representation of names of languages."
3 A language identifier that has been registered with the IANA. The language
identifier begins with the prefix i- or I-.
3 A language identifier that has been assigned by the user or agreed on
between parties in private use. The language identifier must begin with the
prefix x- or X- to ensure that it does not conflict with names that are later
standardized or registered with IANA.
Enclose the language identifier in single or double quotation marks.
TRANSLATEDTEXT="string"
specifies a portion of the presentation in the specified language. Enclose the string
in single or double quotation marks.
Requirement: Required.

USER Statement
Speciﬁes information about users involved in the study.
Requirement: Optional for exporting.

Restriction: This is an advanced statement. You must be familiar with CDISC ODM.

Requirement:
Metadata attributes must be stored in a SAS data set that you reference in

the DATA= argument. You cannot specify metadata attributes in the USER statement.

USER DATA=libref.member-name ;
68 USER Statement � Chapter 6

Arguments

speciﬁes the user’s role in the study.

Requirement: Optional.

LOGINNAME="user-ID"
specifies the user ID that the user uses to log in to the clinical trials data system.
Enclose the user ID in single or double quotation marks.
Requirement: Optional.
DISPLAYNAME="name"
specifies a short name for the user. Enclose the name in single or double quotation
marks.
Requirement: Optional.
FULLNAME="name "
specifies the full name of the user. Enclose the name in single or double quotation
marks.
Requirement: Optional.
LASTNAME="name "
specifies the last name of the user. Enclose the name in single or double quotation
marks.
Requirement: Optional.
FIRSTNAME="name "
specifies the first name of the user. Enclose the name in single or double quotation
marks.
Requirement: Optional.
ORGANIZATION="name "
specifies the user’s organization. Enclose the name in single or double quotation
marks.
Requirement: Optional.
STREETNAME="street-address"
specifies the street address in the user’s postal address. Enclose the address in
single or double quotation marks.
Requirement: Optional.
CITY="name "
specifies the city name in the user’s postal address. Enclose the name in single or
double quotation marks.
Requirement: Optional.
CDISC Procedure for CDISC ODM � USER Statement 69

STATEPROV="state-or-province"
specifies the state or province in the user’s postal address. Enclose the state or
province in single or double quotation marks.
Requirement: Optional.
COUNTRY="name "
specifies the country name in the user’s postal address. This value must be an ISO
3166 two-letter country code. Enclose the name in single or double quotation
marks.
Requirement: Optional.
POSTALCODE="code "
specifies the postal code in the user’s postal address. Enclose the code in single or
double quotation marks.
Requirement: Optional.
OTHERTEXT="string"
specifies any other text that is needed in the user’s postal address. Enclose the
text in single or double quotation marks.
Requirement: Optional.
EMAIL="e-mail-address"
specifies the user’s e-mail address. Enclose the address in single or double
quotation marks.
Requirement: Optional.
PICTFILENAME="filename "
specifies a filename that contains a picture of the user. Enclose the filename in
single or double quotation marks.
Requirement: Optional.
PICTIMAGETYPE="file-type "
specifies the image file type. Enclose the file type in single or double quotation
marks.
Requirement: Optional.
PAGER="number"
specifies the user’s pager number. Enclose the number in single or double
quotation marks.
Requirement: Optional.
FAX="number"
specifies the user’s fax number. Enclose the number in single or double quotation
marks.
Requirement: Optional.
PHONE="number "
specifies the user’s phone number. Enclose the number in single or double
quotation marks.
Requirement: Optional.
LOCATIONOID="ODM-identifier"
specifies a reference to a location definition. Enclose the identifier in single or
double quotation marks. A string of characters up to the maximum OID length
that is defined in CDISC ODM is supported.
Requirement: Optional.
70 LOCATION Statement � Chapter 6

LOCATION Statement
Speciﬁes information about the physical location of the study.
Requirement: Optional for exporting.

Restriction: This is an advanced statement. You must be familiar with CDISC ODM.

Requirement:Metadata attributes must be stored in a SAS data set that you reference in

the DATA= argument. You cannot specify metadata attributes in the LOCATION

statement.

LOCATION DATA=libref.member-name ;

Arguments

NAME="location-name"
speciﬁes the name of the location. Enclose the name in single or double quotation
marks.
Requirement: Required.

LOCATIONTYPE=SPONSOR | SITE | CRO | LAB | OTHER

specifies the type of location.
Requirement: Required.
STUDYOID="ODM-identifier"
specifies a unique identifier for the study in which this location is participating.
Enclose the identifier in single or double quotation marks. A string of characters
up to the maximum OID length that is defined in CDISC ODM is supported.
Requirement: Required.

METADATAVERSIONOID="ODM-identifier"
specifies the metadata version that is used at the location. Enclose the identifier
in single or double quotation marks. A string of characters up to the maximum
OID length that is defined in CDISC ODM is supported.
Requirement: Required.
EFFECTIVEDATE="date"
specifies the date of the metadata version, in compliance with ISO 8601 guidelines.
Enclose the date in single or double quotation marks.
Requirement: Required.
CDISC Procedure for CDISC ODM � CLINICALDATA Statement 71

SIGNATURE Statement
Speciﬁes information about the signatures required in administering the study.

Restriction:This is an advanced statement. You must be familiar with CDISC ODM.

Requirement: Optional for exporting.

Requirement: Metadata attributes must be stored in a SAS data set that you reference in

the DATA= argument. You cannot specify metadata attributes in the SIGNATURE

statement.

SIGNATURE DATA=libref.member-name ;

Arguments

DATA=libref.member-name
specifies the SAS data set that contains the metadata attributes. The libref, which is
assigned with the LIBNAME statement, is an alias for the data storage location
where member-name is stored.
SIGNATUREOID="ODM-identifier"
specifies a unique identifier for the signature. Enclose the identifier in single or
double quotation marks. A string of characters up to the maximum OID length
that is defined in CDISC ODM is supported.
Requirement: Required.
METHODOLOGY=DIGITAL | ELECTRONIC
specifies the form in which the signature was stored.
Requirement: Required.
MEANING="string"
specifies information about the context in which the signature has meaning.
Enclose the string in single or double quotation marks.
Requirement: Required.
LEGALREASON="string"
specifies why signature authentication is necessary. Enclose the string in single or
double quotation marks. A string of characters up to the maximum OID length
that is defined in CDISC ODM is supported.
Requirement: Required.

CLINICALDATA Statement
When importing, identifies the output SAS data set and specifies where the data content in the
CDISC ODM XML document begins; when exporting, identifies the input SAS data set and specifies
any optional metadata attributes.
Requirement:
Required for both importing and exporting.

Requirement:
When exporting, the optional metadata attributes must be speciﬁed in the

CLINICALDATA statement.

72 CLINICALDATA Statement � Chapter 6

CLINICALDATA
OUT=libref.member-name SASDATASETNAME="name" |
DATA=libref.member-name <metadata-attributes> ;

Arguments

OUT=libref.member-name
identifies the output SAS data set. A SAS data set is any file that is accessed by
SAS, such as a SAS data file or a file that points to data from other sources, such as
a DBMS table that is accessed with a SAS/ACCESS engine. The libref, which is
assigned with the LIBNAME statement, is an alias for the data storage location
where member-name is stored.
Requirement: Required for importing.
SASDATASETNAME="name"
specifies a CDISC ODM ItemGroupDef attribute that identifies where the data
content in the XML document begins. Enclose the name in single or double quotation
marks.
Requirement: Required for importing.
DATA=libref.member-name
specifies the input SAS data set that contains the clinical data and the required
KeySet members to be exported to the XML document. A SAS data set is any file
that is accessed by SAS, such as a SAS data file or a file that points to data from
other sources, such as a DBMS table that is accessed with a SAS/ACCESS engine.
The libref, which is assigned with the LIBNAME statement, is an alias for the data
storage location where member-name is stored.
The required KeySet members include the following:
__STUDYOID
__METADATAVERSIONOID
__SUBJECTKEY
__STUDYEVENTOID
__STUDYEVENTREPEATKEY
__FORMOID
__FORMREPEATKEY
__ITEMGROUPOID
__ITEMGROUPREPEATKEY
__TRANSACTIONTYPE
Requirement: Required for exporting.
See also: “CDISC ODM KeySet Members” on page 6
metadata-attributes
includes the following syntax, which must be specified in the CLINICALDATA
statement:
NAME="string"
specifies the study name. Enclose the string in single or double quotation marks.
Requirement: Optional for exporting.
DOMAIN="domain-name"

ORIGIN="string"

PURPOSE="string"

CDISC Procedure for CDISC ODM � CONTENTS Statement 73

COMMENT="string"
speciﬁes submission information as deﬁned in CDISC Submission Metadata
Model. Enclose each value in single or double quotation marks.
Requirement: Optional for exporting.

INVESTIGATORREF=NO | YES
determines whether PROC CDISC imports the unique identiﬁer for the
investigator user. INVESTIGATORREF=YES creates the SAS variable
__USEROID in the imported SAS data set.
Default: NO
Requirement: Optional for importing.
Requirement: To specify INVESTIGATORREF=YES, you must also specify
ODMMINIMUMKEYSET=NO in the ODM statement.
SITEREF=NO | YES
determines whether PROC CDISC imports the unique identiﬁer for the study
location. SITEREF=YES creates the SAS variable __LOCATIONOID in the
imported SAS data set.
Default: NO
Requirement: Optional for importing.
Requirement: To specify SITEREF=YES, you must also specify

ODMMINIMUMKEYSET=NO in the ODM statement.

CONTENTS Statement
Describes the contents of a CDISC ODM SAS data set in the SAS log.
Interaction: To control the line size for the SAS log, use the LINESIZE= SAS system
option.
Interaction:
Use the ODM statement LONGNAMES= processing option to determine the
sources of captured SAS name parameters and to control the maximum length of SAS
name parameters that is valid. See “ODM Statement” on page 57.
Featured in: “Example: Describing a CDISC ODM SAS Data Set with the CONTENTS
Statement” on page 42

CONTENTS TABLE="name";

Arguments

TABLE="name"
speciﬁes a CDISC ODM SAS data set name, which is an ItemGroupDef attribute
that identiﬁes where the data content in the XML document begins. Enclose the
name in single or double quotation marks. The source of the captured SAS name is
determined by the ODM statement LONGNAMES= processing option.
Requirement: Required.
74 DATASETS Statement � Chapter 6

DATASETS Statement
Produces a directory listing of the CDISC ODM XML document in the SAS log.
Interaction: To control the line size for the SAS log, use the LINESIZE= SAS system
option.

Interaction:
Use the ODM statement LONGNAMES= processing option to determine the

sources of captured SAS name parameters and to control the maximum length of SAS

names that is valid. See “ODM Statement” on page 57.

Featured in: “Example: Listing a Directory with the DATASETS Statement” on page 46

DATASETS;

Arguments
The DATASETS statement has no arguments.
75

CHAPTER

7
CDISC Procedure for CDISC
SDTM

Overview: CDISC Procedure for CDISC SDTM 75

Syntax: CDISC Procedure for CDISC SDTM 75
PROC CDISC Statement for CDISC SDTM 75
SDTM Statement 76
DOMAINDATA Statement 76

Overview: CDISC Procedure for CDISC SDTM

PROC CDISC performs data content validation on a SAS data set that conforms to
CDISC SDTM version 3.1. PROC CDISC validates the SAS data set against domain
deﬁnitions that are provided by CDISC SDTM.

Syntax: CDISC Procedure for CDISC SDTM

Restriction: PROC CDISC is supported in the following operating environments:
Windows, UNIX, and z/OS.
Restriction: PROC CDISC supports only one CDISC model and one DOMAINDATA
statement per invocation.

PROC CDISC MODEL=SDTM ;

SDTM SDTMVersion="version-number" ;
DOMAINDATA DATA=libref.member-name DOMAIN=domain
CATEGORY=category ;

PROC CDISC Statement for CDISC SDTM

Speciﬁes CDISC SDTM as the model and validates a SAS data set that conforms to CDISC SDTM.
Requirement: Required.

PROC CDISC MODEL=SDTM;

76 SDTM Statement � Chapter 7

Argument

MODEL=SDTM
speciﬁes CDISC SDTM as the model.

Requirement: Required.

Interaction: The model speciﬁcation determines the syntax for the PROC CDISC

statement and subsequent procedure statements. Specifying MODEL=SDTM

requires that the next statement must be the SDTM statement.

SDTM Statement
Speciﬁes the CDISC SDTM version number.
Requirement: Required.

SDTM SDTMVersion="version-number";

Arguments

SDTMVersion="version-number"
speciﬁes the CDISC SDTM version number. The valid value is 3.1. Enclose the

number in single or double quotation marks.

Requirement: Required.

DOMAINDATA Statement
Identiﬁes the SAS data set to be validated.
Requirement: Required.

DOMAINDATA DATA=libref.member-name DOMAIN=domain CATEGORY=category;

Arguments

DATA=libref.member-name
specifies the SAS data set that conforms to CDISC SDTM. A SAS data set is any file
that is accessed by SAS, such as a SAS data file or a file that points to data from
other sources, such as a DBMS table that is accessed with a SAS/ACCESS engine.
The libref, which is assigned with the LIBNAME statement, is an alias for the
data storage location where member-name is stored.
Requirement: Required.
CDISC Procedure for CDISC SDTM � DOMAINDATA Statement 77

DOMAIN=domain-code
speciﬁes a unique two-character domain code. Each domain is a collection of
observations that are common to a speciﬁc subject. PROC CDISC currently supports
15 of the domains in CDISC SDTM version 3.1. The trial design components category
include the majority of unsupported domains.
Requirement: Required.
The following table lists the codes for the supported domains:

Table 7.1 CDISC SDTM Domains Supported by PROC CDISC

Supported CDISC SDTM Domain Code

Demography DM
Comments CO

Concomitant Medications CM

Exposure EX

Substance Use SU
Adverse Events AE

Disposition DS

Medical History MH

ECG Test Results EG

Inclusion/Exclusion Exception IE

Laboratory Test Results LB

Physical Examinations PE

Questionnaires QS

Subject Characteristics SC
Vital Signs VS

CATEGORY=model-type
speciﬁes a domain model type. Each model type represents a category from which a
domain is derived.
Requirement: Required.
The following table lists the supported model types:

Table 7.2 CDISC SDTM Domain Types

Domain Model Type

Demography Special

Comments Special

Concomitant Medications Interventions

Exposure Interventions

Substance Use Interventions

Adverse Events Events

Disposition Events
78 DOMAINDATA Statement � Chapter 7

Domain Model Type

Medical History Events

ECG Test Results Findings

Inclusion/Exclusion Exception Findings

Laboratory Test Results Findings

Physical Examinations Findings

Questionnaires Findings
Subject Characteristics Findings

Vital Signs Findings

4
P A R T

Appendixes

Appendix 1. . . . . . . . . Sample XML Document 81

Appendix 2. . . . . . . . . Recommended Reading 89

APPENDIX

1
Sample XML Document

Sample CDISC ODM XML Document 81

Sample CDISC ODM XML Document

This is an example of an XML document that conforms to CDISC ODM.

<?xml version="1.0" encoding="windows-1252" ?>

<!-

Clinical Data Interchange Standards Consortium (CDISC)

Operational Data Model (ODM) for clinical data interchange

You can learn more about CDISC standards efforts at

http://www.cdisc.org/standards/index.html

-->

<ODM xmlns="http://www.cdisc.org/ns/odm/v1.2"

xmlns:ds="http://www.w3.org/2000/09/xmldsig#"

xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"

xsi:schemaLocation="http://www.cdisc.org/ns/odm/v1.2 ODM1-2-0.xsd"

ODMVersion="1.2"

FileOID="000-00-0000"

FileType="Snapshot"

Description="Adverse events from the CTChicago file"

AsOfDateTime="2009-03-31T14:01:41"

CreationDateTime="2009-03-31T14:01:41">

<!--

GlobalVariables is a REQUIRED section in ODM markup

-->

<StudyName>CDISC Connect-A-Thon Test Study III</StudyName>

<StudyDescription>This file contains test data from a previous CDISC Connect-A-Thon.</StudyDescription>

<ProtocolName>CDISC-Protocol-00-000</ProtocolName>

</GlobalVariables>
82 Sample CDISC ODM XML Document � Appendix 1

<!-

Internal ODM markup required metadata

-->

<MetaDataVersion OID="v1.1.0" Name="Version 1.1.0">

<StudyEventRef StudyEventOID="SE.VISIT1" OrderNumber="1" Mandatory="Yes" />

</Protocol>

<StudyEventDef OID="SE.VISIT1" Name="Study Event Definition" Repeating="Yes" Type="Common">

<FormRef FormOID="FORM.AE" OrderNumber="1" Mandatory="No" />

</StudyEventDef>

<FormDef OID="FORM.AE" Name="Form Definition" Repeating="Yes">

<ItemGroupRef ItemGroupOID="IG.AE" Mandatory="No" />

</FormDef>

<!-

Columns defined in the table

-->

<ItemGroupDef OID="IG.AE" Repeating="Yes"

SASDatasetName="AE"

Name="Adverse Events"

Domain="AE"

Comment="Some adverse events from this trial">

<ItemRef ItemOID="ID.TAREA" OrderNumber="1" Mandatory="No" />

<ItemRef ItemOID="ID.PNO" OrderNumber="2" Mandatory="No" />

<ItemRef ItemOID="ID.SCTRY" OrderNumber="3" Mandatory="No" />

<ItemRef ItemOID="ID.F_STATUS" OrderNumber="4" Mandatory="No" />

<ItemRef ItemOID="ID.LINE_NO" OrderNumber="5" Mandatory="No" />

<ItemRef ItemOID="ID.AETERM" OrderNumber="6" Mandatory="No" />

<ItemRef ItemOID="ID.AESTMON" OrderNumber="7" Mandatory="No" />

<ItemRef ItemOID="ID.AESTDAY" OrderNumber="8" Mandatory="No" />

<ItemRef ItemOID="ID.AESTYR" OrderNumber="9" Mandatory="No" />

<ItemRef ItemOID="ID.AESTDT" OrderNumber="10" Mandatory="No" />

<ItemRef ItemOID="ID.AEENMON" OrderNumber="11" Mandatory="No" />

<ItemRef ItemOID="ID.AEENDAY" OrderNumber="12" Mandatory="No" />

<ItemRef ItemOID="ID.AEENYR" OrderNumber="13" Mandatory="No" />

<ItemRef ItemOID="ID.AEENDT" OrderNumber="14" Mandatory="No" />

<ItemRef ItemOID="ID.AESEV" OrderNumber="15" Mandatory="No" />

<ItemRef ItemOID="ID.AEREL" OrderNumber="16" Mandatory="No" />

<ItemRef ItemOID="ID.AEOUT" OrderNumber="17" Mandatory="No" />

<ItemRef ItemOID="ID.AEACTTRT" OrderNumber="18" Mandatory="No" />

<ItemRef ItemOID="ID.AECONTRT" OrderNumber="19" Mandatory="No" />

</ItemGroupDef>

<!-

Column attributes as defined in the table

-->

<ItemDef OID="ID.TAREA" SASFieldName="TAREA" Name="Therapeutic Area" DataType="text" Length="4">

<CodeListRef CodeListOID="CL.$TAREAF" />

Sample XML Document � Sample CDISC ODM XML Document 83

</ItemDef>

<ItemDef OID="ID.PNO" SASFieldName="PNO" Name="Protocol Number" DataType="text" Length="15" />

<ItemDef OID="ID.SCTRY" SASFieldName="SCTRY" Name="Country" DataType="text" Length="4">

<CodeListRef CodeListOID="CL.$SCTRYF" />

</ItemDef>

</ItemDef>

<ItemDef OID="ID.LINE_NO" SASFieldName="LINE_NO" Name="Line Number" DataType="integer" Length="2" />

<ItemDef OID="ID.AETERM" SASFieldName="AETERM" Name="Conmed Indication" DataType="text" Length="100" />

<ItemDef OID="ID.AESTDT" SASFieldName="AESTDT" Name="Derived Start Date" DataType="date" />

<ItemDef OID="ID.AESEV" SASFieldName="AESEV" Name="Severity" DataType="text" Length="1">

<CodeListRef CodeListOID="CL.$AESEV" />

</ItemDef>

<ItemDef OID="ID.AEREL" SASFieldName="AEREL" Name="Relationship to study drug" DataType="text" Length="1">

</ItemDef>

<ItemDef OID="ID.AEOUT" SASFieldName="AEOUT" Name="Outcome" DataType="text" Length="1">

<CodeListRef CodeListOID="CL.$AEOUT" />

</ItemDef>

<ItemDef OID="ID.AEACTTRT" SASFieldName="AEACTTRT" Name="Actions taken re study drug" DataType="text" Length="1">

</ItemDef>

<ItemDef OID="ID.AECONTRT" SASFieldName="AECONTRT" Name="Actions taken, other" DataType="text" Length="1">

<CodeListRef CodeListOID="CL.$AECONTR" />

</ItemDef>

<!-

Translation to ODM markup for any PROC FORMAT style

user defined or SAS internal formatting specifications

applied to columns in the table

-->

<CodeList OID="CL.$TAREAF" SASFormatName="$TAREAF" Name="$TAREAF" DataType="text">

<TranslatedText xml:lang="en">Oncology</TranslatedText>
</Decode>

</CodeListItem>

</CodeList>

<CodeList OID="CL.$SCTRYF" SASFormatName="$SCTRYF" Name="$SCTRYF" DataType="text">

<TranslatedText xml:lang="en">United States</TranslatedText>

</Decode>

</CodeListItem>
84 Sample CDISC ODM XML Document � Appendix 1

</CodeList>

<CodeList OID="CL.$F_STATU" SASFormatName="$F_STATU" Name="$F_STATU" DataType="text">

<TranslatedText xml:lang="en">Source verified, not queried</TranslatedText>

</Decode>

</CodeListItem>

<TranslatedText xml:lang="en">Source verified, queried</TranslatedText>

</Decode>
</CodeListItem>

</CodeList>

<CodeList OID="CL.$AESEV" SASFormatName="$AESEV" Name="$AESEV" DataType="text">

</Decode>

</CodeListItem>

<TranslatedText xml:lang="en">Moderate</TranslatedText>

</Decode>

</CodeListItem>

<Decode>
<TranslatedText xml:lang="en">Severe</TranslatedText>

</Decode>

</CodeListItem>

<Decode>
<TranslatedText xml:lang="en">Life Threatening</TranslatedText>

</Decode>

</CodeListItem>

</CodeList>

<CodeList OID="CL.$AEREL" SASFormatName="$AEREL" Name="$AEREL" DataType="text">

</Decode>

</CodeListItem>
<CodeListItem CodedValue=’1’>

<TranslatedText xml:lang="en">Unlikely</TranslatedText>

</Decode>

</CodeListItem>
<CodeListItem CodedValue=’2’>

<TranslatedText xml:lang="en">Possible</TranslatedText>

</Decode>

</CodeListItem>
Sample XML Document � Sample CDISC ODM XML Document 85

<TranslatedText xml:lang="en">Probable</TranslatedText>

</Decode>

</CodeListItem>

</CodeList>

<CodeList OID="CL.$AEOUT" SASFormatName="$AEOUT" Name="$AEOUT" DataType="text">

<TranslatedText xml:lang="en">Resolved, no residual effects</TranslatedText>

</Decode>
</CodeListItem>

<TranslatedText xml:lang="en">Continuing</TranslatedText>

</Decode>
</CodeListItem>

<TranslatedText xml:lang="en">Resolved, residual effects</TranslatedText>

</Decode>
</CodeListItem>

<TranslatedText xml:lang="en">Death</TranslatedText>

</Decode>

</CodeListItem>
</CodeList>

<CodeList OID="CL.$AEACTTR" SASFormatName="$AEACTTR" Name="$AEACTTR" DataType="text">

</Decode>

</CodeListItem>

<Decode>
<TranslatedText xml:lang="en">Discontinued permanently</TranslatedText>

</Decode>

</CodeListItem>

<TranslatedText xml:lang="en">Reduced</TranslatedText>
</Decode>

</CodeListItem>

<TranslatedText xml:lang="en">Interrupted</TranslatedText>
</Decode>

</CodeListItem>

</CodeList>

<CodeList OID="CL.$AECONTR" SASFormatName="$AECONTR" Name="$AECONTR" DataType="text">

86 Sample CDISC ODM XML Document � Appendix 1

</Decode>

</CodeListItem>

<TranslatedText xml:lang="en">Medication required</TranslatedText>

</Decode>

</CodeListItem>

<Decode>
<TranslatedText xml:lang="en">Hospitalization required or prolonged</TranslatedText>

</Decode>

</CodeListItem>

<Decode>
<TranslatedText xml:lang="en">Other</TranslatedText>

</Decode>

</CodeListItem>

</CodeList>

</MetaDataVersion>
</Study>

<!-

Administrative metadata

-->
<AdminData />

<!-

Clinical Data : AE
Adverse Events

Some adverse events from this trial

-->

<ClinicalData StudyOID="STUDY.StudyOID" MetaDataVersionOID="v1.1.0">

<FormData FormOID="FORM.AE" FormRepeatKey="1">

<ItemGroupData ItemGroupOID="IG.AE" ItemGroupRepeatKey="1">

<ItemData ItemOID="ID.TAREA" Value="ONC" />

<ItemData ItemOID="ID.PNO" Value="143-02" />

<ItemData ItemOID="ID.SCTRY" Value="USA" />

<ItemData ItemOID="ID.LINE_NO" Value="1" />

<ItemData ItemOID="ID.AETERM" Value="HEADACHE" />

<ItemData ItemOID="ID.AESTMON" Value="06" />

<ItemData ItemOID="ID.AESTDAY" Value="10" />

<ItemData ItemOID="ID.AESTDT" Value="1999-06-10" />

<ItemData ItemOID="ID.AEENMON" Value="06" />

<ItemData ItemOID="ID.AEENDAY" Value="14" />

<ItemData ItemOID="ID.AEENYR" Value="1999" />

Sample XML Document � Sample CDISC ODM XML Document 87

<ItemData ItemOID="ID.AEENDT" Value="1999-06-14" />

<ItemData ItemOID="ID.AEREL" Value="0" />

<ItemData ItemOID="ID.AEOUT" Value="1" />

<ItemData ItemOID="ID.AEACTTRT" Value="0" />

<ItemData ItemOID="ID.AECONTRT" Value="1" />

</ItemGroupData>

<ItemGroupData ItemGroupOID="IG.AE" ItemGroupRepeatKey="2">

<ItemData ItemOID="ID.TAREA" Value="ONC" />

<ItemData ItemOID="ID.PNO" Value="143-02" />

<ItemData ItemOID="ID.SCTRY" Value="USA" />

<ItemData ItemOID="ID.F_STATUS" Value="V" />

<ItemData ItemOID="ID.AETERM" Value="CONGESTION" />

<ItemData ItemOID="ID.AESTMON" Value="06" />

<ItemData ItemOID="ID.AESTDAY" Value="11" />

<ItemData ItemOID="ID.AESTYR" Value="1999" />

<ItemData ItemOID="ID.AEENMON" Value="" />

<ItemData ItemOID="ID.AEENDAY" Value="" />

<ItemData ItemOID="ID.AEENYR" Value="" />

<ItemData ItemOID="ID.AEENDT" Value="" />

<ItemData ItemOID="ID.AEREL" Value="0" />

<ItemData ItemOID="ID.AEOUT" Value="2" />

<ItemData ItemOID="ID.AEACTTRT" Value="0" />

<ItemData ItemOID="ID.AECONTRT" Value="1" />

</ItemGroupData>
</FormData>

</StudyEventData>

</SubjectData>

</ClinicalData>

</ODM>
88

APPENDIX

2
Recommended Reading

Here is the recommended reading list for this title:

3 SAS XML LIBNAME Engine: User’s Guide
3 SAS Companion that is speciﬁc to your operating environment
3 Base SAS focus area at support.sas.com/rnd/base
3 For information about XML (Extensible Markup Language), see the Web site
www.w3.org/XML
For a complete list of SAS publications, go to support.sas.com/bookstore. If you
have questions about which titles you need, please contact a SAS Publishing Sales
Representative at:

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90

Index

B E
BASICDEFINITIONS statement 65
exporting

CDISC ODM, with metadata attributes in data sets 33

CDISC ODM, with metadata attributes in statement syn

C tax 28

CDISC models 3
CDISC ODM, with optional statements 38

CDISC ODM 5

KeySet members 6
G
metadata attributes 9

PROC CDISC statement 55

GLOBALVARIABLES statement 64

syntax 54

CDISC ODM examples

describing data sets with CONTENTS statement 42

importing

exporting with metadata attributes in data sets 33

CDISC ODM, with default KeySet processing 16

exporting with metadata attributes in statement syntax 28

CDISC ODM, with KeySet processing options 19

exporting with optional statements 38

CDISC ODM, with language identiﬁers 21

importing with default KeySet processing 16

CDISC ODM, with OrderNumber attributes 27

importing with KeySet processing options 19

importing with language identiﬁers 21

K
importing with OrderNumber attributes 27

listing a directory with DATASETS statement 46

KeySet members 6, 16, 19

CDISC overview 3

CDISC procedure 3
L
CDISC ODM syntax 54
language identiﬁers 21

CDISC SDTM syntax 75

LOCATION statement 70

syntax overview 4

CDISC SDTM 11

PROC CDISC statement 76

M
syntax 75
metadata attributes 28, 33

validating data sets 11

metadata attributes for CDISC ODM 9

CDISC SDTM examples

METADATAVERSION statement 66

validating data sets 49

validating Oracle tables 50

O
CLINICALDATA statement 72

ODM statement 57

CONTENTS statement 42, 73

Oracle tables

validating for CDISC SDTM 50

D OrderNumber attributes 27

data sets

describing with CONTENTS statement 42

P
validating for CDISC SDTM 49
PRESENTATION statement 67

DATASETS statement 46, 74

PROC CDISC statement

directory listing 46
CDISC ODM 55

DOMAINDATA statement 76
CDISC SDTM 76

92 Index

S V

SDTM statement 76
validating

SIGNATURE statement 71

CDISC SDTM data sets 11, 49

statements (optional) 38

STUDY statement 63
CDISC SDTM Oracle tables 50

U X

USER statement 68
XML documents 5

Your Turn

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Include the full title and page numbers (if applicable).
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66
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