CDISC, the non-profit standards organization that has published several drug development-related data standards, recently released CDASH version 1.0. CDASH, or Clinical Data Acquisition Harmonization Standards, resulted from Opportunity #45 in the FDA’s “Critical Path Opportunities,” and recommends the data to be captured for 16 core safety data domains. Click here to access the CDASH standard.
CDASH has several goals:
Simplify data capture for investigative sites. This was the original goal as reflected in the FDA opportunities list.
Recommend a minimum set of data to be collected, and identify data that are often on CRFs but are either unnecessary or can be captured or derived from other sources.
Define standard variable names and relationships that are optimized for data capture. It also includes sample CRF Completion Instructions and implementation information.
Ensure that the standards are compatible with (or at least mappable to) CDISC’s SDTM standards (electronic data regulatory submission requirements).
Kestrel is a CDISC Registered Service Provider for CDASH