Clinical Content & Reuse

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).

What is Clinical Content & Reuse (CC&R)

Click on the Harmonized Model Content, Reuse Capabilities and Clinical Template Suite sections to learn more about CC&R.

CCR Reuse Capabilities Harmonized Model Content Clinical Template Suite Guiding Principles CPT, SAP, CSR Clinical Content & Reuse Flexible Implementation Options eCPT, eSAP, eCSR GCP AND ICH ALIGNMENT STRATEGIC ENGAGEMENT TRACEABILITY REGISTRIES Reuse Capabilities Clinical Template Suite Harmonized Model Content REUSE CAPABILITIES Enabling digitization, traceability, and reuse of content for downstream processes, documents, and registries through the metadata and automation. HARMONIZED MODEL CONTENT Concise, consistent model wording used across multiple documents that aligns with GCP, ICH, requirements and includes feedback from stakeholders and regulators involved in clinical research. CLINICAL TEMPLATE SUITE (CTS) Includes Word and technology-enabled templates for the protocol (CPT/eCPT), statistical analysis plan (SAP/ eSAP), and clinical study report (CSR/eCSR).

The Clinical Content & Reuse (CC&R) Initiative aims to enhance clinical trial processes by providing harmonized structure and proposed model content within clinical trial documents that can be reused throughout the project lifecycle to enable digitization and traceability through automation.

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 IRBs, Ethics Committees, and Health Authorities across the lifecycle of a clinical trial

Increased use of 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

Benefits for 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 Clinical Template Suite includes the SAP and CSR templates, which are aligned to the CPT and ready for use and implementation
  • The eTemplates enable digitization and reuse of content for downstream processes, documents, and registries

Benefits

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

Available Solutions

Please see the Initiative Solutions 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.

Similar Initiatives

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Clinical Data Standards

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