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Addressing Agency-specific Requirements

Adverse Events/Unanticipated Problems

  • Policy I5D Noncompliance and the related procedures [pdf]
  • Policy II2F Adverse Events and Unanticipated Problems [pdf]
  • Reporting Form: Internal or Local Medical Event, Incident or Occurrence [docx]
    Reports from sponsors or safety committees about external events, problems, or findings that may not meet the definition for an unanticipated problem (refer to the policy or procedure for details) are to be summarized in the relevant sections of the Protocol Renewal Request form when the protocol is being renewed. Reports from sponsors or safety committees that require changes to the research protocol or consent form must be submitted immediately as modification requests, for IRB review and approval.
  • Reporting Form: Unexpected Problems or Events [docx]
    Reports from sponsors or safety committees about external events, problems, or findings that may not meet the definition for an unanticipated problem (refer to the policy or procedure for details) are to be summarized in the relevant sections of the Protocol Renewal Request form when the protocol is being renewed. Reports from sponsors or safety committees that require changes to the research protocol or consent form must be submitted immediately as modification requests, for IRB review and approval.

Biomedical

Conflict of Interest

Exempt Research

Human Subjects Research Determination

Permission and Assent

Protocol Application

Protocol Modification

Renewal

Research Involving Protected Health Information

Social Behavioral

VA Sierra Nevada Health Care System (VASNHCS)

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