Use these tools to guide your own review of study records and processes. Feel free to change these documents to better fit your study.
Info Sheets
Sample Documents
- Signature / Delegation of Authority Log Template (Reviewed 2026)
- Site Screen and Enrollment Log
- Note to File
Self-Assessments
- Informed Consent Required Elements Checklist Fillable Form Revised August 2026
- Regulatory Binders Self-Assessment Tool
- Subject Record Informed Consent Files Self-Assessment Fillable FormĀ Revised August 2026