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Clinical Trials Resource Group

Clinical Trials Resource Group

Number7IND Process: Safety Reports

An IND Safety Report is expedited, written notification to the FDA of an adverse experience associated with the use of a study drug that is both serious and unexpected. Investigator-sponsors of IND applications are subject to compliance with both the adverse event reporting requirements of the sponsor and the requirements of the investigator.

To file an IND Safety Report for human adverse events prepare:

  1. Cover Letter. Prominently state "IND Safety Report" (Example )
  2. Form FDA 3500A (MedWatch)
  3. Form 1571 (Check box "Safety Report")

To file an IND Safety Report for animal data:

  1. Cover Letter. Prominently state "IND Safety Report"
  2. Narrative description (any finding from tests in laboratory animals that a significant risk for human subjects including reports of mutagenicity, teratogenicity or carcinogenicity)
  3. Form 1571 (Check box "Safety Report")

When to file:

  1. For any unexpected fatal or life-threatening SAE associated with the use of the drug, the IND Sponsor-Investigator notifies the FDA of the SAE by telephone or fax as soon as possible, but no later than seven calendar days after initial receipt of the SAE. Then the investigator follows with the written report no later than 15 days since the occurrance.
  2. For serious and unexpected, but non-fatal, file as soon as possible and no later than 15 days after you receive the information of the respective adverse event information or laboratory animal data.

For more on filing requirements and follow-up: Adverse Event ReportingNotification requirements and format