1. All unanticipated problems involving risk to subjects or others.
2. Suspensions, clinical holds (voluntary or involuntary), or terminations of this research by the IRB, the institution, the sponsor, or regulatory agencies.
3. Any instances of serious or continuing noncompliance with the federal regulations or IRB requirements.
4. 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.
5. 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 (usarmy.detrick.medcom-usamrmc.other.hrpo@health.mil), by facsimile (301-619-7803). For questions- please contact your assigned OHRO Reviewer.