Forms & Templates
| Title/Description | Format(s) | Notes | Questions? | Admin. Office |
|---|---|---|---|---|
| Exiting Faculty Checklist | Faculty Separation Checklist | Word | Valorie Buchholz | OCT |
| Good Clinical Practice Investigator Checklist | GCPI Checklist | Word | Valorie Buchholz | OCT |
Clinical Trials Quality Assurance (CTQA) Regulatory Templates
- Adverse Event Log
- Close-out Checklist
- Concomitant Medication/Therapies Worksheet
- Delegation of Responsibility Log
- Deviation Log
- Device Accountability Log
- Eligibility Checklist Template
- Enrollment Log
- FDA Part 11 Certification
- Feasibility Assessment
- Good Clinical Practices Checklist
- Guidance for Completing a Supervisory Plan for Clinical Research
- Informed Consent Process and HIPAA Authorization Documentation
- Inventory List for Study Storage Documents
- Master Subject ID Log
- Monitoring Plans
- Monitoring Visit Log
- Participant Enrollment Documentation
- PI Supervisory Plan for Clinical Research
- Protocol/Amendment Tracking Log
- SAE Log
- Standard Operation Procedure/Work Instruction Templates
- Data Managment
- Informed Consent Process
- Investigational Product (IP) Accountability Standard Operating Procedure and Work Instructions
- Management and Reporting Adverse Events
- Training
- Study Start-Up Checklist
- Training Log
- Transfer of Subject Checklist