Experience from creating electronic systems with generic endpoint review and adjudication flows

Background An increasing number of Clinical Trial Web Portals now include systems to manage endpoint adjudication. These cover the entire process from the initial identification of potential endpoints, the creation of electronic endpoint packages, and assignment of endpoints to members of the relevant Clinical Endpoint Committee (CEC) to the final adjudication verdict being entered into the system. The number and types of users involved at each stage and the number and size of Endpoint Committees varies across trials, depending on the trial design and requirements of the Sponsor, so the challenge has been to create generic systems that can handle the variations in design.