Glossary Term

IND Safety Report

Data & Safety

Also known as: IND safety reports, 312.32 report

A sponsor report to FDA of serious, unexpected, suspected adverse reactions and certain other safety findings in an IND study.

Required under 21 CFR 312.32, IND safety reports must be submitted on accelerated timelines (7 days for fatal/life-threatening unexpected reactions; 15 days for other qualifying reports) and shared with all participating investigators.

Need IRB review for your study?

Elemental IRB provides fast, transparent ethical oversight for commercial and academic research.

See pricing → How it works →