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 CPT Journey
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 SAP
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 CSR
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 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

Benefits

The Clinical Content & Reuse Initiative aims to enhance the clinical development process across sites, regulators, patients, and sponsors.

Available Assets

Please see the Initiative Assets page for guidance and to download our Clinical Template Suite.

Disclaimer

These materials are provided ‘AS IS’ WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. TransCelerate and its members do not accept any responsibility for any loss of any kind including loss of revenue, business, anticipated savings or profits, loss of goodwill or data, or for any indirect consequential loss whatsoever to any person using these materials or acting or refraining from action as a result of the information contained in these materials. Any party using these materials bears sole and complete responsibility for ensuring that the materials, whether modified or not, are suitable for the particular use and are accurate, current, commercially reasonable under the circumstances and comply with all applicable laws and regulations.

Nothing in these documents should be construed to represent or warrant that persons using these documents have complied with all applicable laws and regulations. All individuals and organizations using these documents bear responsibility for complying with the applicable laws and regulations for the relevant jurisdiction.

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