Rationale

Increasing complexity within clinical trial protocols makes implementation, reporting, and review difficult for sites, regulators, and patients. The lack of consistency across protocols compounds the issue. The Common Protocol Template (CPT) team actively engaged with industry stakeholders and regulators to create a clinical trial protocol template containing a common structure and proposed language. The CPT is a foundational element in the longer-term movement towards an electronic, machine-readable protocol and overall end-to-end efficiencies.

 

Guiding Principles for the Common Protocol Template

Structure Must… Content Must… Endpoints Must…
Be streamlined Develop common wording Map to an objective
Be consistent Align with GCP, ICH & EU requirements Support use of CDISC TA standards
Allow for all phases & study types

Benefits

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

Benefits for Sites

  • Streamlines structure and content to ease the navigation of information and generate efficiency by increasing consistency across sponsor protocols
  • Allows easy access to the schedule of assessments
  • Establishes clear alignment between objectives and endpoints
  • Enables references to specific workflow documentation (e.g., study manuals, pharmacy guides, etc.) to avoid duplicative and lengthy protocol sections

Benefits for Regulators, IRBs, and Ethics Committees

  • Increases use of data standards with streamlined structure and content
  • Reduces complexity of IRB, Ethics Committee, and Health Authority reviews
  • Improves facilitation of regulatory input for protocol design

Benefits for Sponsors

  • Provides a ready-to-use clinical trial protocol template for all phases and therapeutic areas in a basic Microsoft Word or technology-enabled edition
  • Enables automation of downstream processes and improved reuse of content
  • Streamlines structure and content for ease of input, review, implementation, and extraction
  •  Uses data standards and libraries (e.g., therapeutic, participant, and safety)

Benefits for Patients

  • Facilitates efficiencies across the protocol development and implementation process
  • Aims to ease use by clinical trial sites, offers the opportunity to improve communication with patients, and contributes to getting medicines to market faster

Available Assets

Please see Initiative Assets to download our Common Protocol Template.

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