CDASH v1.1

Published Date:

Developed with participation from organizations in all three ICH (International Conference on Harmonization) regions (US, Europe and Japan), CDASH v1.1 describes the recommended data collection fields for 16 domains, including demographics, adverse events, and other domains common to most therapeutic areas and clinical research phases. Additionally, CDASH v1.1 includes implementation guidelines, best practice recommendations, regulatory references.