Value to regulators:
- Increases use of data standards with streamlined structure and content
- Improves access to protocol information
- Reduces complexity while easing the 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 thus 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 enhanced the clinical development process across clinical trial sites, regulators, patients, and sponsors.
Disclaimer
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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.
