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)