Reportable events

Applies to: all

The HSC's Reportable Events: Recommendations for investigator-initiated multisite studies addresses the common challenges of reporting in a single IRB environment — what relying sites must report, to whom, on what timeline, and how the Reviewing IRB's policies interact with local ones.

• Reportable Events recommendations (PDF)
• SMART Talk on reportable events: video · slides

For what the Agreement itself requires, see Who reports to OHRP, FDA, sponsors, and funders and Subject complaints and injuries.

See also - Who reports to OHRP, FDA, sponsors, and funders - Harmonization guidance by topic