Office of Research and Innovation
University of Louisville
Louisville, Ky. 40202
502.852.6512, 502.852.8361 (Fax)
Looking for a unit within the Office of Research and Innovation? Contact information here.
Templates/Resources
Departmental Signoffs for Initial Submissions
- Beginning July 1, 2023, only new IRB applications for studies falling under full board review require sign off in iRIS by the department assigned Scientific and Scholarly Merit Reviewer and Department Chair. More information can be found here.
- 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)
Templates
- Consent and HIPAA Templates
- Protocol Template
- Protocol Summary of Changes Template
- Translated Consent/HIPAA Templates
Conducting Research in Jefferson County Public Schools
- Contact the JCPS IRB with your research idea to ensure the research will be allowed within the school system.
- You must obtain approval from the JCPS IRB prior to submitting to the University of Louisville IRB.
- Information for conducting research in the JCPS System and submitting to the JCPS IRB can be found on their website. The website includes JCPS policies, templates, and application process information.
- Once you obtain JCPS IRB approval, submit the approved materials to the UofL IRB through iRIS following the steps outlined on the Initial Submission tab.
Case Reports
Case reports by University of Louisville definition are medical information collected and presented on up to five patients to highlight an interesting treatment, presentation, or outcome.
- Based on local policy, researchers developing case reports must use the Case Report Self-Certification Decision Tool to certify that their project meets the definition of a case report and as a notification to the IRB of the activity.
- If your proposed activity does not meet the definition of a case report, you must submit to the IRB for review via iRIS.
Federal Regulations and Guidance
- ClinicalTrials.gov Posting Requirements
- NIH: Certificates of Confidentiality
- Good Clinical Practice and Belmont Report
- FDA/Department of Health and Human Services
Study Management Tools for Investigators and Coordinators
- Adverse Event Log
- 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 Template
- Essential Documents for Investigator Initiated Studies
- IND Decision Worksheet
- IDE Decision Worksheet
- Protocol Training Log
- Sequestering Plan Template
- Adverse Event Log Template
- Site Self-Assessment Checklist
- Subject Eligibility Checklist
