# Adverse Event Reporting to IRBs — Improving Human Subject Protection:  Guidance for Clinical Investigators, Sponsors, and IRBs - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/adverse-event-reporting-to-irbs-improving-human-subject-protection-guidance-for-clinical-investigators-sponsors-and-irbs/8b4e7049-16fc-40f8-b121-81ece765bc26

> FDA guidance document: Adverse Event Reporting to IRBs — Improving Human Subject Protection:  Guidance for Clinical Investigators, Sponsors, and IRBs. Issue date: January 14, 2009. Get complete insights and analysis.

---

## Details

- Title: Adverse Event Reporting to IRBs — Improving Human Subject Protection:  Guidance for Clinical Investigators, Sponsors, and IRBs
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Office of the Commissioner
- Office URL: /offices/office-of-the-commissioner/79483979-9582-427f-ac3d-46c715811424
- Issue Date: 2009-01-14
- Last Changed: 2020-05-06
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2007-D-0202">FDA-2007-D-0202</a>

## Related Documents

- [Financial Disclosure by Clinical Investigators:  Guidance for Clinical Investigators, Industry,and FDA Staff](https://www.globalkeysolutions.net/guidances/guidance-document/financial-disclosure-by-clinical-investigators-guidance-for-clinical-investigators-industryand-fda-staff/a2fdcaf8-673b-4e11-9017-f37e4d719af8)
- [Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/patient-reported-outcome-measures-use-in-medical-product-development-to-support-labeling-claims-guidance-for-industry/506b29a8-b7ee-47d9-b155-79fd4d5b76e2)
- [Electronic Source Data in Clinical Investigations:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/electronic-source-data-in-clinical-investigations-guidance-for-industry/6d72d592-c70b-47f5-810c-0542a685c1b5)