Quorum Review’s IRB services requires reporting of all events that may constitute unanticipated problems involving risk to research participants or others as well as new or updated safety information relating to a study or study product. Reportable events/information must be reported to Quorum within 10 business days of their occurrence. Reportable events include:
- Serious Adverse Events
- Major Protocol Deviations/Violations
- Research participant complaints
- Adverse audit or enforcement actions (e.g., Form FDA 483, FDA Warning Letters, FDA Establishment Inspection Reports (EIRs), adverse Sponsor audit findings, etc.)
- IND Safety Reports that qualify as Unanticipated Problems
- New/updated safety information that may increase risk to participants
- Reports, publications, or interim results or findings
- Recalls, Withdrawals, or Clinical Holds
- Any other incident that could qualify as an Unanticipated Problem
- Any incident that must be reported according to the policies of the sponsor or site
If your sponsor’s safety submission requirements are different than Quorum’s you may submit the event to Quorum regardless and we will respond with a standard acknowledgement.
For additional guidance with specific examples regarding the types of incidents that require prompt reporting, Quorum strongly encourages all sponsors, Clinical Research Organizations, investigators and research staff to make use of the following resources:
- Webinar – Understanding Reporting Obligations to the IRB: This webinar specifically clarifies safety information and unanticipated problems, and provides guidance on what, how, and when to submit such information
- Safety Information and Unanticipated Problems Guidelines: This robust guidance document contains thorough descriptions, examples, reporting criteria, and Quorum reporting instructions for all safety information and unanticipated problems
- Quick Reference – Reporting Unanticipated Problems to Quorum Review IRB: Quorum suggests increasing visibility of reporting requirements for unanticipated problems at investigative sites by printing this simplified and easy-to-reference one sheet (two-sided) for posting in your research office.