Below is a list of references that will help you be successful in your position. Please review the items in this list and familiarize yourself with the Checklists as these will help guide you in your reviews.
Cayuse Human Subjects Module Instructions/Guidance
- DocumentCayuse Reviewer Role Guide.pdf (3.81 MB)
Protocol Review Process
Checklists
- Study Completeness Checklist (DOCX)
- Reportable Event Reviewer Checklist (DOCX)
- Document
- DocumentCR IRB Approval Checklist 05062022.docx (42.72 KB)
Training Presentations
- HIPAA and Expedited Review – May 2017 (PPTX)
- Reportable Events and Revised Common Rule – November 2018 (PPTX)
- Regulatory Issues – May 2017 (DOCX)
Federal/External Regulations & Guidelines
- (contains a list of Exempt categories in 46.101)
- (via OHRP Web Site)
- and Guidance on Certificates of Confidentiality
- on numerous topics