IRB eProtocol Checklist
Title: ________________________________________________
Protocol ID: _____
Review Type: __________
- Personnel Information
- Participant Population(s) Checklist
- Study Location(s) Checklist
- General Checklist
- Funding Checklist
Resources
- Qualified Staff
- Training
- Facilities
- Sufficient Time
- Access to Target Population
- Access to Resources
- Lead Investigator
Protocol Information
q Expedited Paragraphs [Title, Type of Study]
q 1-3 [Purpose, Study Procedures, Background]
q 4 [Ratioisotopes or Radiation Machines]
q 5,6 [Devices, Drugs, Reagents or Chemicals]
q 7 [Medical Equipment]
q 8 (a-g) [Participant Population]
q 8 (h-m) [Participant Population continued]
q 9 (a-d) [Risks]
q 9 (e) [Risks – Special Participant Populations]
q 10, 11 [Benefits, Procedures for Confidentiality]
q 12 [Potential Conflict of Interest]
q 13 [Consent]
q 14 [Assent]
q 15 [HIPAA]
q 16 [Attachments]
q Obligations [Protocol Director Obligations + agreement]
q Submit Protocol q Protocol approved
Date submitted: ____________ Date approved: ____________