Versions Compared

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 characterizing to characterize products, from 

The CDASH Model establishes a standard way to collect data across studies. Guidance in this section implements the CDASH Model and provides:

  • Basic data collection guidance and best practices.
  • Guidance for development, management, and use of case report forms (CRFs).

The TIG supports development of CRFs but does not formally address data collected via other sources. However, the principles and metadata presented can be applied to eSource (also known as "non-CRF") data, such as vendors' electronic data transfer standards and ePRO data structures, as applicable.

The SDTM establishes a standard way to collect data across studies. Guidance in this section implements the SDTM and provides:

  • Basic data collection guidance and best practices.
  • Guidance for development of datasets

SDTM vs SENDdata from in vitro and in vivo nonclinical studies, and data to assess the impact of products on the health of individuals.

Pagenav