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

The link to the guidance document Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs - Improving Human Subject Protection has been updated from the draft guidance document to the final guidance document (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126572.pdf)