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
- Audit Monitoring – Site Information Audit Prep Checklist
- Audit Monitoring Review Sheet
- Monitoring Visits
- On-Site Monitoring Visit Agenda Checklist
- Post-Monitoring Visit Letter Attachment
- Self-Audit Toolkit
Signature Log/Delegation of Authority Log
- Department Signature Sheet
- Site Staff Roles & Responsibilities
- Delegation of Authority Log
FDA Forms
- IND Annual Report Template
- IRB-FDA Tracking
- ACRP: Revisiting the Form FDA 1572
- FDA: How to Complete Form FDA 1571 and Form FDA 1572
- FDA: Clinical Trial Forms
Study Communications
Study Training
- Human Subjects Education via CITI
- Good Clinical Practice Certification
- HIPAA 101 via Learn@Work
- Personnel Protocol Training Memo to File
Deviation
Study Protocol Templates
- Protocol Templates for Clinical Trials (NIH Templates for both biomedical and behavioral & social sciences research involving human subjects)
- NIH Toolkit for Clinical Researchers
Regulatory Binder
- Regulatory Binder Templates
- Regulatory Document Tracker
- Regulatory Document Tracking Form
- Regulatory File Checklist
- NIH Toolkit for Clinical Researchers
- Study Budget Example
- Internal Budget Template