Case Report Form Design, Strategy, and Standards

The phrase “garbage in, garbage out” can be applied to the data collection
efforts in clinical trials. To avoid this pitfall, it’s important to be thorough
in the evaluation of the data collection items that will validate the protocol
hypothesis endpoints and statistical analysis. It’s also important to consider
the future compilation of data from multiple clinical trials for agency
submission and the assurance that the data are in compatible format. With
this goal in mind, it’s essential for data collection to be consistent, concise
and compatible - hence the need for standards. CDISC and CDASH are
instrumental in the establishment of these standards. This web seminar will discuss the timing of case report form (CRF) design in relation to clinical trial startup and the team that will contribute to the data collection recommendations. We will review the resources utilized in determining what data collection is required and the current standards - CDISC and CDASH - for CRF data content. Best practices for CRF design as documented by the Society for Clinical Data Management Good Clinical Data Management Practices (SCDM GCDMP) will also be presented.