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The SDTM establishes a standard way to tabulate data across studies. Guidance in this section provides implementations of SDTM to represent data characterizing products, from The CDASH Model establishes a standard way to collect data across studies.

• 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 SENDSDTM 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.