Forms
Initial Protocol Application Forms
Choose one for a new study. See the Protocol Form Flowchart – what form do I need to submit
- Protocol application form – non-exempt, 10.23.2025
- Protocol application form – exempt, 08.26.2025
- Protocol application form – Secondary Data and Specimen Analysis, 10.16.2025
- Human subjects research determination form, 03.18.2025
- 118 Determination Letter or “Just-in-Time” request form, 07.19.2023
Additional Forms for Initial Application
- PI assurance form, 01.16.2025
- Research team form, 08.03.2023
- Research Registry or Repository form, 12.2.2024
- International research form, 07.15.2024
- Certificate of translation form, 07.19.2023
- Investigational Device Checklist, 11.17.2025
- AI Systems Used in HSR Form, 09.08.2025
Post-approval Forms
- Modification form, 07.24.2025
- Protocol closure form, 03.22.2024
- Renewal form, 07.19.2023
- Incident, Adverse Event, or Reportable New Information form 03.25.2024
- EDD program only: Cycle 2 Exempt Self-Determination Form, 03.23.2026
Multi-site Research and Reliance Forms
Please note: Please complete the forms using Word and submit the forms as Word files attached to your submission email. The IRB uses Track Changes to provide comments and feedback on submissions. We advise against the use of cloud-based tools (such as Google docs) to complete the forms as we have noted some formatting incompatibilities that may make it difficult to review the forms. We do not accept links to files or documents unless the files are too large to send via email (for example, a video file). We are no longer accepting copies of these forms which are converted into PDF or other formats.
| See Get Started for guidance on how to submit an initial study |