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) irrespective of the inclusion of collected data in subsequent tabulation datasets.
The TIG supports development of CRFs but does not formally address data collection via other sources. Guidance in this section suggests a format to be presented to those entering collected data using CRFs but does not dictate any data structure or system in which to store the collected data.
- Use the CDASH recommendations to develop company standards, taking into consideration the stage of clinical development and the individual therapeutic area requirements. To gain the greatest benefit from using the CDASH standard, CRFs should not be developed on a trial-by-trial basis within the implementer organization, but rather be brought into a study from a library of approved CRFs based on the CDASH Model and CDASHIG, whenever practicable.
Overview
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