IND SAFETY REPORTS
In cases where the PI is both the Investigator and the Sponsor, the PI assumes the responsibility of reporting certain SAEs to the FDA and IRB. Once it is determined that an SAE must go to the FDA an IND Safety Report is prepared (usually the PI, in association with the medical monitor, will determine whether an IND Safety Report needs to be prepared). An IND Safety Report is an expedited, written notification to the FDA of an adverse experience associated with the use of a study drug that is both serious and unexpected.
When and where to report:
- 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. The investigator follows with the written report no later than 15 days after the occurrence.
- For serious and unexpected, but non-fatal adverse events, file as soon as possible and no later than 15 days after initial receipt of the SAE.
- All SAEs must be reported to the IRB within 5 business days as "reportable new information."
FDA Guidance: IND Safety Reports
IDE SAFETY REPORTS
An unanticipated adverse device effect is any serious adverse effect on health or safety, any life-threatening problem or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the application; or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.
When and where to report:
- Report to the device manufacturer as soon as possible but no later than 10 working days after the investigator first learns of the effect.
- Report to the IRB as soon as possible but no later than 5 business days as "reportable new information."
Thereafter the sponsor (or Sponsor-Investigator) shall submit such additional reports concerning the effect as FDA requests. The investigator will submit further information as the IRB request.
FDA Guidance: IDE report details