| 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 |
