IRBs are required by FDA and OHRP regulations to review “Unanticipated Problems Involving Risks to Subjects or Others” (UPIRTSO). As such, only those IND Safety Reports that may, in the opinion of the CRO/Sponsor or Principal Investigator, represent an unanticipated problem involving risks to subjects or others be reported to PrimeIRB. In addition, any adverse event observed during the conduct of a study would be considered an UPIRTSO and reported to PrimeIRB only if it were unexpected, related or possibly related to participation in the research, and serious.
Please see the PrimeIRB Investigator Handbook for more specific information.
Submitting Reportable Events
Please log on to LINQ™ and select the correct form (CRO/Sponsor or Investigator). The system will guide you through the xForm and prompt you for any required documentation or information.
It is the responsibility of the CRO/Sponsor to submit the reports on a study-wide basis and the responsibility of the Principal Investigator to submit the reports on a site-level basis. PrimeIRB recognizes that the same report may be received twice.
Please email us if you have any questions.
PrimeIRB will acknowledge submission of the Reportable Event within 48 hours. Documentation will be available through LINQ™