Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 III A. ; IV.
From GxPlex
| Document information | |
|---|---|
| Reference | USA FDA Guidance for Clinical
Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 |
| Validity area | USA |
| Scope(s) | G |
| Document name | FDA Guidance for Clinical
Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection |
| Version / Revision | Jan-2009 |
| Status | Superseded / Invalid |
| Document type | Official recommendation |
| Language(s) | EN |
| Description | Guidance for Clinical Investigators, Sponsors, and IRBs
Adverse Event Reporting to IRBs — Improving Human Subject Protection |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 5 — Unit 5.1.4 |
| Scope | G |
| Document part | III A. ; IV. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Unanticipated device effect, Ethics committee, Investigator safety reporting, Investigational drug (IMP), FDA |
| Comment | Reporting of AEs to IRBs in clinical trials |
Content
[...] III. REPORTING AEs TO IRBs IN CLINICAL TRIALS OF DRUG AND BIOLOGICAL PRODUCTS CONDUCTED UNDER IND REGULATIONS A. How to Determine If an AE is an Unanticipated Problem that Needs to Be Reported In general, an AE observed during the conduct of a study should be considered an unanticipated problem involving risk to human subjects, and reported to the IRB, only if it were unexpected, serious, and would have implications for the conduct of the study (e.g., requiring a significant, and usually safety-related, change in the protocol such as revising inclusion/exclusion criteria or including a new monitoring requirement, informed consent, or investigator’s brochure). An individual AE occurrence ordinarily does not meet these criteria because, as an isolated event, its implications for the study cannot be understood. [...] IV. REPORTING AEs TO IRBs IN CLINICAL TRIALS OF DEVICES UNDER THE IDE REGULATIONS The investigational device exemption (IDE) regulations define an unanticipated adverse device effect (UADE) as “any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects” (21 CFR 812.3(s)). [...]
