Versions Compared

Old Version 7

changes.mady.by.user Christine Connolly

Saved on

compared with

New Version Current

changes.mady.by.user Sterling Hardy

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Comment: Migration of unmigrated content due to installation of a new plugin

The SDTM establishes a standard way to tabulate data across studies.

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-806
Guidance in this section implements the SDTM for TIG Product Description, Nonclinical, and Product Impact on Individual Health use cases. TheCDISCStandard for Exchange of Nonclinical Data (SEND) is a specialized approach to implement the SDTM for nonclinical research. Guidance for nonclinical use cases in this this section reflects implementation of the SDTM per SEND. Implementation of the SDTM is simply referred to as "SDTM" for all other use cases in this section.

Pagenav

Standards for tabulation

Be aware: 

  • Data that were collected on separate CRF modules or pages may fit into an existing domain (e.g., as separate questionnaires into the QS domain, prior and concomitant medications in the CM domain).

What is data tabulation? ADD here

SDTM Section 1.4.1 

The permissible variables do not include all the variables that are allowed for the domain; they are a set of variables that the SDS Team considered likely to be included.

SDTM - The SDTM Standard Domain Models

The collected data for a given study may use standard domains from this and other SDTM implementation guides as well as additional custom domains based on the 3 general observation classes.