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Template Documents for Regulatory and Participant Binders

To request any of the templates below, please submit a DDRS service request.


Regulatory Binders

  • Regulatory Records Checklist Template
  • Adverse Event Tracking Log Template
  • Delegation of Responsibilities and Signature Log Template
  • Financial Interest Disclosure Form Templates
  • Monitoring Visit Summary Log Templates
  • Regulatory Binder Protocol Deviation Log Template
  • Regulatory Binder Note to File Templates
  • Regulatory Binder Pointer Page Templates
  • Screening and Enrollment Log Template
  • Visitor Signature Log Template

Participant Binders

  • Informed Consent Checklist Template
  • Participant Binder Protocol Deviation Log Template
  • Participant Binder Note to File Templates