What types of events should be reported to Quorum as potential Unanticipated Problems?
Quorum considers the following events to be potential Unanticipated Problems and requires investigators to promptly report each of the following events within ten (10) business days of becoming aware of the event’s occurrence:
- 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 involving risk to participants or others
- New/updated safety information that may increase risk to participants
- Reports, publications, or interim results or findings
- Recalls, wthdrawals, or clinical holds
- Any other incident that could qualify as an unanticipated problem involving risk to participants or others, such as the loss of a laptop with confidential study data (more examples below)
- Any incident that must be reported according to the policies of the sponsor or site
For additional guidelines regarding the types of incidents that require prompt reporting, refer to the Safety Information and Unanticipated Problems Reporting Guidelines.