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 study sites and global regulatory authorities while enabling downstream automation of many clinical processes and aligning to industry data standards. The CPT includes a common structure, proposed common text, and regulator-accepted endpoint definitions that may be used across protocols with little to no editing at the discretion of the user. The first CPT was released in 2015 and it has been evolving ever since.
During this webinar, attendees will be introduced to the rationale, development and benefits of the CPT. TransCelerate speakers will discuss their Common Protocol Template Initiative and how the organization is interacting with industry stakeholders and regulators to create and maintain a model clinical trial protocol template.
Learning Objectives
1. Understand the rationale, development and benefits of the Common Protocol Template (CPT);
2. Learn about CPT structure: Core Template and Libraries, features of the basic Word and Technology Enabled Editions;
3. Speakers will provide feedback on your exposure to this document template across industry.