CDISC served as a key stakeholder, providing input to the development of Common Protocol Template (CPT). CPT aligns with NIH/FDA-developed Template connecting the parallel universes of clinical care and research as stated by FDA Commissioner during the CDISC/FDA strategy session in August 2016.

Read the Q&A, “Updated common protocol templates align clinical trial objectives, endpoints” with TransCelerate CEO Dalvir Gill, who discusses the many benefits of CPT, including how it establishes common endpoints that are aligned with CDISC Therapeutic Area (TA) Standards. CDISC TA Standards are extensions of CDISC Foundational Standards and include disease-specific metadata, examples and guidance on implementing Foundational Standards.