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EU-PEARL’s Suite of master protocol templates

Life cycle of medicinal products and medical devices:
Resource type:

Added by: Ekaterina Chashnikova
March 14, 2024

Master templates of 5 clinical trial documents:

  • Master Protocol Template* (MPT) V4 25April2023
  • Intervention Specific Appendix* (ISA) template V4 25April2023
  • Statistical Analysis Plan^ (SAP) template V3 25April2023
  • Data Monitoring Committee (DMC) charter template V1 25April2023
  • Guidance for supplementary information to the CTR Cover Letter associated with the Master protocol and ISA submission V4 25April20235

The templates can be downloaded as MS Office documents.


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