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Extreme Make-Over! How the TransCelerate Common Protocol Template Makes Your Job Easier

The Common Protocol Template (CPT) is a harmonized and streamlined approach to the format and content of clinical trial protocols. It aims to ease interpretation by the study sites and global regulatory authorities while enabling downstream automation of many clinical processes and aligning to industry data standards. TransCelerate developed the CPT with input from investigators, study coordinators, members of IRBs, IECs, the TransCelerate CRO Forum, and regulatory authorities. The CPT includes a common structure, proposed model text, and regulator-accepted endpoint definitions that may be used across protocols with little to no editing at the discretion of the user. Participants will understand how the CPT frees up valuable clinic time by allowing easier access to information that helps researchers assess a protocol and decreases site training time thus allowing more time for patient care.