| Document Name | Type | Number | Download |
|---|---|---|---|
| Protocol Deviation (Major) /Violation Report | Required | F-018 | icon-doc |
| Safety Information and Unanticipated Problem Cover Page | Required | F-021 | icon-doc |
| Serious Adverse Event Report | Required | F-022 | icon-doc |
| Unanticipated Problem Report | Required | F-024 | icon-doc |
| Prospective Protocol Waiver/Exception Request Form | Required | F-035 | icon-doc |
| Safety Information and Unanticipated Problems Guidelines | Guidance | G-036 | icon-doc |
| Safety and Unanticipated Problems Powerpoint | Guidance | G-042 | icon-pdf |
| Handbook for Quorum Review IRB (Requires an OnQ Portal Account) | Guidance | G-043 | icon-aspx |
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