The CDASH Model establishes a standard way to collect data across studies. Guidance in this section implements the CDASH Model and provides:
- Basic standards and best practices for data collection.
- Guidance for development, management, and use of case report forms (CRFs).
The TIG standard directly addresses 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.
Language in the table below is used throughout this section and should be interpreted as specified.
Overview
Content Tools