OHRO Reporting Requirement Reminder
► OHRO Reporting Requirement Reminder
Principal Investigators must promptly report the following study events upon identification.
- All unanticipated problems involving risk to subjects or others.
- Suspensions, clinical holds (voluntary or involuntary), or terminations of this research by the IRB, the institution, the sponsor, or regulatory agencies.
- Any instances of serious or continuing noncompliance with the federal regulations or IRB requirements.
- The knowledge of any pending compliance inspection/visit by the Food and Drug Administration (FDA), Office for Human Research Protections, or other government agency concerning this clinical investigation or research.
- The issuance of inspection reports, FDA Form 483, warning letters, or actions taken by any government regulatory agencies.
Promptly report by telephone (301-619-2165), by email (email@example.com), by facsimile (301-619-7803). For questions- please contact your assigned OHRO Reviewer.