What is Clinical Content & Reuse (CC&R)
The Clinical Content & Reuse (CC&R) Initiative, formerly known as Common Protocol Template (CPT), aims to enhance clinical trial processes by developing common content for reuse across clinical trial documents in the Clinical Template Suite (CTS).
The CTS works towards having electronic, machine-readable documents and improving overall end-to-end efficiencies. The CTS includes basic word and electronic templates for the protocol (CPT), statistical analysis plan (SAP), and clinical study report (CSR). The templates can be used individually or together to simplify and streamline content and achieve content reuse.
In 2015, the first version of the Common Protocol Template (CPT) was released and it has been evolving ever since. The CPT is a harmonized and streamlined approach to the format and content of clinical trial protocols. The CPT includes a common structure, proposed model text, and regulator-accepted endpoint definitions for use across protocols with little to no editing at the discretion of the user.
The Common Statistical Analysis Plan (SAP) provides a common layout and model content for SAP documentation, which seamlessly integrates with the TransCelerate CPT and CSR. The template aligns with ICH E9 (R1) for the use of Estimands. In addition, the template addresses global regulatory requirements for reporting and disclosure.
The Common Clinical Study Report (CSR) aims to provide a lean, common, and streamlined structure to report data (no benefit/risk interpretation). The CSR has streamlined common wording consistent with CPT, adheres to global requirements, and avoids redundancy by referring to appended documents.
The use of these templates is at the discretion of the user. Tools, guidance, and FAQs are available on the Clinical Content & Reuse Solutions page.
Bringing Value to our Stakeholders
Value to regulators:
- Increases use of data standards with streamlined structure and content
- Improves access to protocol information
- Reduces complexity while easing of review and interpretation by IRB, Ethics Committee, and Health Authorities across the lifecycle of a clinical trial
Value to sites:
- Streamlining the structure and content improving access to protocol information and increasing consistency across sponsors
- Providing easy access to the schedule of assessments, establishing clear alignment between objectives and endpoints
- Enabling references to documents that facilitate study conduct (e.g., study manuals, pharmacy guides, etc.) to avoid duplicative and lengthy protocol sections
Value to patients:
- Improving access to protocol information
- Facilitating efficiencies across protocol development and implementation processes so that clinical and medical staff can focus on the patient
Value to sponsors:
- The CPT was designed with data standards and libraries and includes regulatory and site feedback aimed at easing submission to health authorities and ethics committees
- The SAP and CSR templates are ready-to-use and aligned to the CPT
- The use of the TransCelerate eTemplates enables content reuse for downstream processes, documents, and registries
The Clinical Content & Reuse Initiative aims to enhance the clinical development process across clinical trial sites, regulators, patients, and sponsors.
Please see the Initiative Solutions page for guidance and to download our Clinical Template Suite.
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