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).
Study Data Tabulation Model : Defines the content
and tabulation standard for regulatory submission of case report tabulations in
clinical research studies
SDTMIG: Intended to guide the organization, structure and
format of clinical trial tabulation datasets submitted to regulatory authority
such as US Food and Drug Administration(FDA)
Data in SDTM
are structured within as
Observation : A
discrete piece of information collected during a trial. Observations are rows
or records within a dataset, described by series of variables (columns).
Ex: Heart-rate observation in the Vital Signs (VS) domain.
Domain:
Collection of observations with a common topic. Each domain is represented by
single dataset and distinguished by unique, two character code that is
consistently used throughout the submission. This code is used in four ways
·
As the dataset name
·
The value of the DOMAIN variable in that
dataset
·
As prefix for most variable names in
that dataset
·
As value in RDOMAIN variable in
relationship tables
|
Two character code for Vital signs domain
|
Variables: There are five
types of variable defined by the role they perform within the observation
Identifier:
Indentifies the observation or record in terms of study,subject,domain,sequence
within the domain etc
Topic: Specify the
focus of the observation
Timing : Define the
timing of the observation
Qualifier: Contains additional information related
to the topic
Rule: Defines an algorithm for
indentifying starts and end,(only used in Trial Design domains)
Core Variables:
These are categorized into three types
