Office of Research and Innovation
University of Louisville
Louisville, Ky. 40202
502.852.6512, 502.852.2594 (Fax)
Looking for a unit within the Office of Research and Innovation? Contact information here.
Templates/Resources
Templates
Departmental Signoffs for Initial Submissions
IRB applications for studies under full board review require sign off in iRIS by the departmental assigned Scientific and Scholarly Merit Reviewer and Department Chair.
- Scientific Reviewer and Department Chair List (by department)
- Instructions for routing an initial submission for Scientific and Department Chair review in IRIS
- Scientific Reviewer and Department Chair Paper Form (if not routed in iRIS for review)
Study Management Tools
- Adverse Event Log 1
- Adverse Event Log 2
- Baseline Concomitant Medication Log
- Billing Compliance Table
- Clarification Memo template (NTF)
- Closure checklist for BIO (pdf)
- Closure checklist for SBE (pdf)
- Consent Process Documentation (example 1) - (pdf)
- Consent Process Documentation (example 2) - (pdf)
- Corrective And Preventive Action Plan (CAPA) (doc)
- Delegation of Responsibilities Log
- Deviation Log
- Device Accountability Log Template
- Drug Dispensing Log Template
- Eligibility Checklist 1
- Eligibility Checklist 2
- Essential Documents for Investigator Initiated Studies
- IND Decision Worksheet
- IDE Decision Worksheet
- Protocol Training Log
- Sequestering Plan Template
- Site Self-Assessment Checklist
