Office of Research Compliance
Institutional and Business
Clinicians
Researchers
Assessment of Disclosed Activities
How to Disclose at RUSH
What to Disclose
Education and Training
CMS Open Payments
COI Related Policies
Technical Assistance
Public Disclosure of Financial Conflict of Interest
COI Frequently Asked Questions
Managing Conflicts
Office of Research Compliance
Institutional and Business
Clinicians
Researchers
Assessment of Disclosed Activities
How to Disclose at RUSH
What to Disclose
Education and Training
CMS Open Payments
COI Related Policies
Technical Assistance
Public Disclosure of Financial Conflict of Interest
COI Frequently Asked Questions
Managing Conflicts
Research Documentation Templates - These tools are provided as a resource to satisfy federal regulations, Good Clinical Practices, local policy and best documentation practices in human subjects research.
Regulatory Tools and Templates
- Regulatory File Content List
- Delegation of Responsibility Log and Instructions
- Protocol Training Log
- Subject Identification Log
- Subject Screening Log
- Subject Enrollment Log
- Sample Tracking Log
- Protocol Deviation and SAE/UAE Log (for tracking and reporting to the IRB, when necessary)
- Note-to-File Template
- Telephone Contact Log
- Monitoring Visit Log
Subject Source Documentation Tools
- Subject Source Documentation Content List
- Source Documentation Tips: ALCOA+
- Informed Consent Process Document
- Screen Failure Documentation Tips
- Adverse Event Log
- Concomitant Medication Log (Template 1)
- Concomitant Medication Log (Template 2)
- End of Study Documentation Template
- Telephone Call Record Template
- Signing, Dating and Correction Source Documents (ALCOA)