CDISC, SDTM and ADaM

Standards
CLINICAL TRIAL DATA FLOW

Protocol CRF Design

Data Data
Collection Conversion

FDA TLF Data

Submission/ Creation Analysis
review
BENEFITS OF STANDARDS

REDUCES COSTS STREAMLINE DATA FACILITATE FDA INCREASE EFFICIENCY IN

COLLECTION SUBMISSION PERFORMING CLINICAL
TRIALS
 CDISC stands for the Clinical Data Interchange Standards Consortium.

It is a standards developing organization that supports data exchange in

medical research from protocol through analysis and reporting of results
.
CLASSIFICATION OF CDISC

Foundational or
Data exchange Controlled
data content
standards Therapeutic areas terminology and
standards
glossary
PRM
SEND SDM-XML,
ODM-XML
LAB

CDASH
Define-XML
SDTM
CTR-XML
ADaM
CDISC STANDARDS
 CDISC STANDARDS
PRM (Protocol Representation Model)

• The PRM is simply a conceptual model

for organizing a protocol.

• The model identifies items typically

found in a protocol and organizes them
into a common structure intended to be
machine readable.
CDISC STANDARDS
PRM (Protocol Representation Model)
 CDSIC STANDARDS
CDASH (Clinical Data Acquisition Standards Harmonization)

• CDASH establishes a standard way to collect

data consistently across studies and
sponsors.

• 16 commonly used CRFs content have been

developed e.g MH, SU, AE,DM etc
 CDSIC STANDARDS
CDASH (Clinical Data Acquisition Standards Harmonization)

Classification:
• Highly Recommended
• Recommended
• Optional

NB: Recommended date format in CDASH is

dd/mm/yyyy
CDSIC STANDARDS
CDASH (Clinical Data Acquisition Standards Harmonization)
 CDSIC STANDARDS
SDTM (Study Data Tabulation Model )

• After the data is collected into a clinical

database, it must be converted into standard
data tables to be used for analysis.

• The study data tabulation model (SDTM)

defines the way in which individual
observations from a clinical study are
compiled.
 CDSIC STANDARDS
ADaM (Analysis data MODEL)

• It describes how to build analysis datasets

and associated metadata. This in turn allows
a statistical programmer to generate tables,
listings, and figures (TLFs) more easily.

• While SDTM is used to create and map

collected data from raw sources, ADaM is all
about creating data that is ready for analysis.
SDTM is ALWAYS the source of the ADaM
data.
 CDSIC STANDARDS
LAB (Laboratory Data Model)

• Lab was established to standardize the

transfer of data between clinical laboratories
and sponsor companies.

• It was developed because of the many

variations between data acquired in
laboratories, such as lab test names and
units.
CDSIC STANDARDS
LAB (Laboratory Data Model)

HL7
Units
Contents of the Model:
Code lists
Date Time Formats
Test/Lab Test LOINC
Data Fields ID

Toxicity NCI
Grade
CDSIC STANDARDS
LAB (Laboratory Data Model)

Contents of the Model Good

Data Fields Transmission
Practice

Subject Study Visit Investigator

Site
 CDSIC STANDARDS
LAB (Laboratory Data Model)

Contents of the Model

Base Base
Specimen battery

Base Test Accession Base Result

 CDSIC STANDARDS
ODM-XML (Operational Data Model)

• The Operational Data Model (ODM) is a

vendor neutral, platform independent
format for interchange and archive of clinical
study data.

• The model includes the clinical data along

with its associated metadata, administrative
data, reference data and audit information.
 CDSIC STANDARDS
SDM-XML (Study/Trial Design Model)

• Study/Trial Design Model in XML (SDM-XML)

is an extension of ODM-XML and allows
organizations to provide rigorous, machine-
readable, interchangeable descriptions of
the designs of their clinical studies, including
treatment plans, eligibility and times and
events.

• SDM-XML defines three key sub-modules –

Structure, Workflow, and Timing.
CDSIC STANDARDS
SDM-XML (Study/Trial Design Model)
CDSIC STANDARDS
SDM-XML (Study/Trial Design Model)
 CDSIC STANDARDS
CTR-XML(Clinical Trial Registration Model)

• An ODM extension for Clinical Trial

Registration

• CTR-XML provides a means for generating

harmonized messages to each of the
registries such as World Health Organization
(WHO), European Medicines Agency (EMA)
EudraCT Registry and United States
ClinicalTrials.gov
CDSIC STANDARDS
CTR-XML(Clinical Trial Registration Model)
 CDSIC STANDARDS
DEFINE-XML

• Define-XML transmits metadata that

describes any tabular dataset structure.

• When used with the CDISC Foundational

Standards, it provides the metadata for
human and animal model datasets using the
SDTM and/or SEND standards and analysis
datasets using ADaM.
 CDSIC STANDARDS
THERAPEUTIC AREAS

• Therapeutic area standards are an extension

of the foundational standards. They serve to
represent data for specific therapeutic areas
such as asthma, diabetes, multiple sclerosis,
and many more.
CDSIC STANDARDS
THERAPEUTIC AREAS
 CDSIC STANDARDS
Controlled Terminology

• CDISC Controlled Terminology is the set of

CDISC-developed or CDISC-adopted standard
expressions (values) used with data items
within CDISC-defined datasets and is used
throughout the clinical research lifecycle,
from data collection through analysis and
submission.
ADaM
Standard
ADaM (Analysis Data Model)

ADaM standards were designed to support submission to a regulatory agency such

as the United States Food and Drug Administration (FDA). It provides a standard for
transferring datasets between sponsors and contract research organizations (CROs),
development partners, and independent data monitoring committees.
ADaM (Analysis Data Model)

An ADaM dataset is a particular type of analysis dataset that either:

(1) is compliant with one of the ADaM defined structures and follows the ADaM
fundamental principles;
OR
(2) follows the ADaM fundamental principles defined in the ADaM model
document and adheres as closely as possible to the ADaMIG variable naming and
other conventions.
F
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Traceability
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Usable and Clear
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The ADaM Data Structures

The ADaMIG describes two ADaM standard data structures:

The subject-level analysis dataset The Basic Data Structure (BDS).

(ADSL)
 All ADaM variable All ADaM
All ADaM character
names must be no
variable variables
more than 8
labels must be
characters in
must be no more
General Variable length, start with a
no more than 200
Naming letter (not
than 40 characters
underscore), and
Conventions be comprised only
characters in length.
in length.
of letters (A-Z),
underscore (_), and
numerals (0-9)
 In general, if SDTM character variables are converted to
numeric variables in ADaM datasets, then they should
be named as they are in the SDTM with an “N” suffix
added. For example, the numeric version of the DM SEX
General Variable variable is SEXN in an ADaM dataset, and a numeric
Naming version of RACE is RACEN
Conventions

Any variable in an ADaM dataset whose name is the

same as an SDTM variable must be a copy of the SDTM
variable, and its label, meaning, and values must not be
modified
Timing Variable Conventions
•Variables whose names end in DT are numeric dates.

•Variables whose names end in DTM are numeric datetimes.

•Variables whose names end in TM are numeric times.

•Names of timing start variables end with an S followed by the characters indicating the
type of timing (i.e., SDT, STM, SDTM), unless otherwise specified .

•Names of timing end variables end with an E followed by the characters indicating the
type of timing (i.e., EDT, ETM, EDTM), unless otherwise specified.
SDTM
Standard
Study Data Tabulation Model (SDTM)

• The SDTM originated as the Submission Data Model (SDM), developed by the
CDISC Submission Data Standards (SDS) Team is a standard for submitting data
tabulations to the FDA in support of marketing applications.

• The first implementation-ready version of the SDTM was released by CDISC in

2004 and was developed to provide a standard for the organization, structure, and
format of tabulation data to be submitted to regulatory agencies.
Data Class

Domain Interventions Events

Findings Trial Design Relationship

Domain

A domain is defined as a collection of observations with a topic-specific commonality about

a subject.

Each dataset is distinguished by a unique, two-character DOMAIN code that should be used
consistently throughout the submission.
Interventions

• The Interventions class captures investigational treatments, therapeutic treatments, and

surgical procedures that are intentionally administered to the subject.
Events

• The Events class captures occurrences or incidents independent of planned study

evaluations occurring during the trial (e.g., ’adverse events’ or ’disposition’) or prior to
the trial (e.g., ’medical history’).
Findings

• The Findings class captures the observations resulting from planned evaluations to
address specific questions such as observations made during a physical examination,
laboratory tests, ECG testing, and sets of individual questions listed on questionnaires
Variable Roles
Qualifier Variables

Grouping Qualifier Result Qualifier Synonym Qualifier

Record Qualifier Variable Qualifier

Core Variables
 4. Identify 5. Determine
1. Determine the 2. Identify Required 3. Identify Expected
Permissible Relationship
Data Class Variables Variables
Variables Variables
General Variable Assumptions

• Data variable names should be limited to 8 characters, and cannot start with a number, nor
should they contain characters other than letters, numbers, or underscores.

• Data variable descriptive names (labels), up to 40 characters, should be provided as data

variable labels.

• The rule for applying the prefix is as follows: All variable names should be prefixed with the
Domain Identifier in which they reside except:

Required Identifiers (STUDYID, DOMAIN, USUBJID)

General Variable Assumptions

Commonly used Merge Keys (VISIT, VISITNUM, VISITDY)

All Demography domain (DM) variables except for the Timing Variables DMDTC, and
DMDY

• It is recommended that textual data be submitted in upper case text.

Actual and Relative Time Assumptions

The template for ISO 8601 dates/times is as follows:

YYYY-MM-DDThh:mm:ss

where:

YYYY = four-digit year

MM = two-digit representation of the month (01=January, etc.)
DD = two-digit day of month (01 through 31)
T = separator to indicate time information follows
hh = two digits of hour (00 through 23) (am/pm is NOT allowed)
mm = two digits of minute (00 through 59)
ss = two digits of second (00 through 59)
Actual and Relative Time Assumptions

The table below provides examples ISO 8601 representation of full and partial
date/time values:
Each dataset or table is accompanied by metadata definitions that provide information about the
variables used in the dataset. The CDISC Submission Metadata Model uses seven distinct
metadata attributes to be defined for each dataset variable in the metadata definition document:
Conformance

Conformance with the CDISC Domain Models is indicated by:

• Following the complete metadata structure for data domains and variables
• Following CDISC domain models wherever applicable
• Including all collected data in one of the standard domains, special-purpose datasets or
general observation- class structures
• Including all Required and Expected variables as columns in a domain
Conformance

• Using CDISC-specified standard domain names and prefixes

• Using CDISC-specified standard variable names
• Using CDISC-specified variable labels
• Using CDISC-specified data types for all variables
• Following CDISC-specified controlled terminology and format guidelines for variables, when
provided.
• Ensuring that each record in a dataset includes a set of keys and a topic variable.
Conclusion