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.
The use of these templates is at the discretion of the user. Tools, guidance, and FAQs are available on the Clinical Content & Reuse Assets 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
Increased use of the CPT across sponsors brings value to sites by:
- 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
Increased use of common clinical content in the protocol can also have a positive impact on patients by:
- 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 sites, regulators, patients, and sponsors.
Please see the Initiative Assets page for guidance and to download our Clinical Template Suite.
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