The latest versions of the Clinical Data Acquisition Standards Harmonization Implementation Guides (CDASHIGs) have been developed in reference to a specific CDASH model. However, the CDASH model is cumulative – each new release builds on the previous model. Therefore, the models are considered backward compatible. The first CDASH documents, such as CDASH v1.1 and the CDASH SAE Supplement, combined concepts of both a model and an implementation guide.
CDASH: The Clinical Data Acquisition Standards Harmonization Implementation Guide (CDASHIG) establishes a standard way to collect data consistently across studies and sponsors so that data collection formats and structures provide clear traceability of submission data into the SDTM, delivering more transparency to regulators and others who conduct data review. The following videos introduce you to the CDASH model and the CDASHIG.