Versions Compared

Old Version 67

changes.mady.by.user Christine Connolly

Saved on

compared with

New Version Current

changes.mady.by.user Lorraine Sobson

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

The purpose of the TIG is to guide the use of CDISC standards

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-40
for the organization, structure, and format of tobacco product data submitted to a regulatory authority. The TIG provides guidance for the:

  • Collection collection of study data with case report forms (CRFs) using the Clinical Data Acquisition Standards Harmonization (CDASH) model;,
  • Tabulation tabulation of study data using the Study Data Tabulation Model (SDTM);, and
  • Creation creation of analysis datasets using the Analysis Data Model (ADaM); , with
  • References references to additional CDISC standards and resources to support implementation.

...