Versions Compared

Old Version 28

changes.mady.by.user Christine Connolly

Saved on

compared with

New Version 29

changes.mady.by.user Christine Connolly

Saved on

Key

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

The SDTM establishes a standard way to tabulate data across studies. Guidance in this section supports and provides implementations of the SDTM to represent data to characterize products, data to identify potential risks and effects on biological processes for products via in vitro and in vivo nonclinical studies, and data to assess the impact of products on the health of individuals. implements the SDTM for TIG Product Description, Nonclinical, and Product Impact on Individual Health use cases. TheCDISC Standards 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.

...