The SDTM establishes a standard way to tabulate data across studies. Guidance in this section implements the SDTM and provides:
- An implementation of SDTM with which to descript
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 SEND
Overview
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