Evolution of SDTM & SDTMIG from version 1.0 - 3.3

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Where the Nervous System findings go?

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What's in CV domain?

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Where the meal/food capture data goes?

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What's in SDTMIG 3.3

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What are keys in SDTM

How to submit ‘NOT DONE’ and ‘NONE’

If group of tests or an individual test is ‘not done’ and the information is captured on CRF, it should be indicated in corresponding dataset

On the other hand, if there is no information for group of tests or an individual test whether it is done/yes/no/not done or data on CRF is missing, a record must not be created to indicate that data was not collected.

How the Results of Findings domain are interpreted

--ORRES,--STRESC,--STRESN

Why ‘SUBJID’ & ‘USUBJID’, purpose of existence of both?

What are 'CDISC Time points' and their role

-TPTREF, -RFTDTC,-ELTM,-TPT,-TPTNUM

DATE & TIME IN FINDINGS DOMAIN

CDISC VISIT VARIABLES

PLANNED VS UNPLANNED

TYPES OF CONTROLLED TERMINOLOGY(CT) IN CDISC SDTM

•  Single asterisk(*) – Specifies there is no CT currently, sponsor defines their own CT while CDISC team may be developing one

         Ex: Variables in DM domain

Variable name	Label	Type	Controlled terminology	Role
ARMCD	Planned arm code	Char	*	Record qualifier
ARM	Description of planned arm	Char	*	Record qualifier

SDTMIG STANDARD DOMAIN

DEMOGRAPHICS-DM

METADATA CONTENTS & ATTRIBUTES

THE SDTM STANDARD DOMAIN MODELS

They are about 46 domains of which 32 clinical data domains are contained into Interventions, Events and Findings.Six domains for trial design and four domains for special purpose.

SDTM DATA CLASSES

Describes the datasets or domains within SDTM. These are of six types as follows

General observation Classes:

Subject level observations collected during the study goes into one of three general observation classes as follows

Types of Qualifier variables

SDTM(Study Data Tabulation Model): An Introduction (continued)

SDTM BASIC CONCEPTS:

Of the numerous standards developed by CDISC, this blog focus on one of the standards i.e SDTM.SDTM is defined   with  two key documents-The Study Data Tabulation Model, and the SDTM Implementation Guide(SDTMIG).