FDA guidance
Adverse Event Reporting to IRBs — Improving Human Subject Protection: Guidance for…
FDA guidance · Final · issued Jan 14, 2009
Key facts
| Title | Adverse Event Reporting to IRBs — Improving Human Subject Protection: Guidance for Clinical Investigators, Sponsors, and IRBs |
|---|---|
| Status | Final |
| Issue date | Jan 14, 2009 |
| Center | Office of the Commissioner |
| Communication type | Guidance Document |
| Docket number | FDA-2007-D-0202 |
| Open for comment | No |
| Document on fda.gov | fda.gov |
At a glance
- None Product codes referenced
- 1–9 Recognized standards referenced
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA guidance documents
FDA guidance documents describe the agency's current thinking on regulatory topics. Drafts are issued for comment before a final version is published.
Source: U.S. Food and Drug Administration (FDA), Guidance Documents