Transcription of Regulatory Binder - ONS
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Regulatory Binder - ONS
Developed by Center for Cancer Research, National Cancer InstituteEndorsed by the CTN SIG Leadership GroupRegulatory BinderIntroduction A regulatorybinder or file contains all study-specific information and Regulatory documentation. It organizes essentialdocuments, provides easy access to essential documents by the trial monitor, auditor, IRB, or Regulatory authorities ( , Office for Human Research Protections, FDA) for review/audit purposes, and allows research team members to reference information. Although the Regulatory Binder is part of the GCP guidelines (GCP E6 Section 8) and not legally binding, it is highly recommended that all intervention trials have a Regulatory Binder , regardless of sponsorship.
Introduction • A regulatory binder or file contains all study-specific information and regulatory documentation. It organizes essential documents,
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