Forms and Templates

Essential Regulatory Documentation

Purpose

Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of Good Clinical Practice and all applicable regulatory requirements.

Best Practice Considerations

  • Review ICH GCP guidance section 8 for a complete list of essential regulatory documentation.
  • File these documents in a timely manner.
  • Store items in reverse chronological order, with the newest items within a section placed at the front of the section.
  • Use notes to file to document if certain documentation is maintained in different locations.

Templates

Monitoring/Auditing

Signature Log/Delegation of Authority Log

FDA Forms

Study Communications

Study Training

Deviation

Study Protocol Templates

Regulatory Binder

Study Closure

Study Initiation/Onboarding