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Common Protocol Template

Rationale

 

Increasing complexity in clinical trial protocols makes implementation and reporting difficult for sites, regulators and patients. The lack of consistency across protocols compounds the issue. The Common Protocol Template Initiative is working with industry stakeholders and regulators to create a model clinical trial protocol template containing a common structure and model language. It will utilize libraries to facilitate common language in areas specific to patient population and therapeutic areas. The common protocol template is a foundational element in the longer-term movement towards an electronic protocol.

Benefits

The Common Protocol Template Initiative aims to enhance the clinical development process across stakeholder groups.

Benefits for Sites

  • Improved access to information: clinical trial protocols streamlined and organized with an investigator focus
  • Increased consistency between sponsor protocols
  • Reduced need for additional workflow documentation (e.g., study manuals)

Benefits for Regulators

  • Reduced complexity of regulatory reviews
  • Increased ease of data interpretation
  • Improved ability to compare clinical trial protocols, facilitating regulatory input on protocol design
  • Increased use of data standards, enabling end-to-end use of metadata and traceability

Benefits for Sponsors

  • Increased operational efficiencies in creation of clinical trial protocols
  • Automation of downstream processes and improved reuse of content
  • Improved conduct of the study and quality of data collected
  • Enabler for therapeutic area standards implementation
  • Enabler for collaborative clinical trials

Benefits for Patients

  • Improved communication with sites due to increased consistency between protocols
  • Improved access to protocol information
  • Increased efficiency in clinical development
  • Getting medicines faster

 

Available Assets

Please see Initiative Assets to download our Common Protocol Template.

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