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Regulatory Files

Definition

• Regulatory files include essential compliance and procedural documents related to a clinical research study and are often captured in regulatory or study binders. Regulatory binders help research teams organize their files, maintain regulatory compliance, and adhere to Good Clinical Practice (GCP) standards for record keeping practices for research involving human subjects.

Templates/forms

• Most sponsors/clinical research organizations will provide forms and documents for maintenance throughout the trial.
• Regulatory Binder Checklist  - External site
• Essential Regulatory Documents Guidance and Binder Tabs - External site

Training

• Essential Documents for the Conduct of a Clinical Trial (Section 8, Good Clinical Practice Guidelines) - External site 
• Regulatory Documentation: What do you need in a regulatory binder? - PDF