Local Resources
- Regulatory Binder Contents
- Sample Site Initiation Visit Agenda
- Sample Monitoring Plan
- Financial Disclosure Form
- Sample Adverse Event Log (Device)
- Sample Adverse Event Log (Drug)
- Sample Concomitant Medication Log
- Sample Compensation Log
- Sample Delegation of Authority Log
- Sample Device Accountability Log (Use)
- Sample Device Accountability Log (Receipt-Return-Repair-Destruction)
- Sample Deviation Log
- Sample Eligibility Checklist
- Sample Informed Consent Process Note
- Sample Screening-Enrollment Log
- Sample Source Data Agreement
- Sample Specimen Tracking Log
- Device Risk Determination Checklist
- Role of the Medical Monitor
- ORRA Study Documentation Guideline