FDA Requirements
Mandatory Safety Report Requirements
- Initial report: Any suspected adverse reaction that is both serious and unexpected must be reported to FDA within 15 calendar days of the Sponsor-Investigator's initial receipt of the information.
- Follow-up report: Any relevant additional information related to a previously submitted IND safety report must be submitted without delay, no later than 15 calendar days after the Sponsor-Investigator receives the information.
Submitting IND Safety Reports
All IND safety reports must be submitted:
- On a Form 3500A (if from clinical trials). See Instructions for completing Form 3500A
- accompanied by FDA Form 1571 - Investigational New Drug Application (IND).
- optional UCSF template: IND Safety Report Cover Letter
- The type of report (initial or follow-up) should be checked in the respective boxes on Forms 3500A and 1571.
The submission must be identified as:
- “IND safety report” for 15-day reports, or
- “7-day IND safety report” for unexpected fatal or life-threatening suspected adverse reaction reports, or
- “Follow-up IND safety report” for follow-up information.
The report must be submitted to an appropriate FDA Review division that has the responsibility to review the IND application under which the safety report is submitted.
FDA recommends that sponsors submit safety reports electronically Other means of rapid communication to the respective review division’s Regulatory Project Manager (e.g., telephone, facsimile transmission, email) may also be used.
FDA Guidance Documents
- Terms such as Adverse Event, Suspected Adverse Reaction, Adverse Reaction, Unexpected, Serious and Life-threatening are defined on this FDA page
- Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices
- Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies (PDF - 227KB)
- Final Rule: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
- Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies Guidance for Industry
- Adverse Event Reporting to IRBs (January 2009) (Investigators must also report adverse events to the UCSF IRB.