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NIMH Reportable Events Policy

(Version date: April 16, 2015)

Purpose

Timely reporting of significant research events to the National Institute of Mental Health (NIMH) is necessary for the NIMH’s oversight of the protection of the rights and welfare of participants in funded research. The purpose of this policy is to outline the NIMH’s expectations of NIMH-funded researchers relating to the submission of reportable events (i.e., Adverse Events (AEs); Serious Adverse Events (SAEs); Unanticipated Problems Involving Risks to Subjects or Others; protocol violations; non-compliance (serious or continuing); suspensions or terminations by monitoring entities (e.g., Institutional Review Board (IRB), Independent Safety Monitor (ISM)); and suspensions or terminations by regulatory agencies (e.g., Office for Human Research Protections (OHRP) or the Food and Drug Administration (FDA)).

Scope and Applicability

This policy applies to the reporting of AEs, SAEs, Unanticipated Problems, protocol violations (significant divergences from the IRB-approved protocol), serious/continuing non-compliance, and suspensions and terminations for clinical research funded (in whole or in part) by the NIMH. This policy is specific to reporting to the NIMH and does not replace regulations or policies requiring reporting of these events to other monitoring entities or regulatory agencies.

General Reporting Policy

Consistent with NIH policy, the Principal Investigator is responsible for the clinical management of the participant and accurate written documentation, investigation, and follow-up of all possible study-related AEs. The investigator is also responsible for describing and adhering to the procedures for identifying, monitoring, and reporting reportable events outlined in the study’s Human Subject’s section of the application. AEs, SAEs, death, Unanticipated Problems, protocol violations, non-compliance, suspensions and terminations should be reported to the NIMH (as the funding sponsor) according to the expectations and timeframes described below.

All reports must be made in writing to the NIMH Program Official (PO). These reports should indicate that the monitoring entities (i.e., the PI and IRB, ISM and/or DSMB) and appropriate regulatory entities (e.g., OHRP, FDA) have been notified in accordance with the approved monitoring plan and federal regulations. Reports should be submitted to the monitoring entity (e.g., a DSMB or ISM) at least annually on a schedule determined by the monitoring entity’s policy. Monitoring entities may require more frequent reporting.

Reportable Event

When is Event Reported to the NIMH

Reported By

IRB/ISM/DSMB/OHRP/FDA Suspensions or Terminations

Any suspension or termination of approval must include a statement of the reason(s) for the action and must be reported promptly to the NIMH PO within 3 business days of receipt.

Regulatory or Monitoring Entity and Investigator

Deaths related to study participation

Deaths must be reported immediately (no later than within 5 business days) of the principal investigator first learning of the death.

Investigator

Unexpected Serious Adverse Events related to study participation

Reported to the NIMH PO within 10 business days of the study team becoming aware of the SAE.

Investigator

Unanticipated Problems Involving Risks to Subjects or Others

Reported to the NIMH PO within 10 business days of the investigator learning of the event.

Investigator

Serious or Continuing Noncompliance

Reported to the NIMH PO within 10 business days of IRB determination

Institution

Adverse Event

For all AEs and SAEs that are deemed expected and/or unrelated to the study, a summary should be submitted to the NIMH PO with the annual progress report.

Investigator

Protocol Violations

With the annual progress report.

Investigator

Documentation to be Submitted for Reportable Events

  • Identifying information for the research protocol (e.g., project title, investigator’s name, and the grant/contract number);
  • The date on which the event occurred and the date at which the PI became aware of the event;
  • A detailed description of the event and impact on the participant(s);
  • A detailed description of the measures taken (including clinical) in response to the event (if any);
  • Confirmation that the appropriate monitoring entities and regulatory bodies have been notified as needed; and
  • A description of any changes to the protocol or other corrective actions that have been taken or are proposed in response to the event.

NIMH Evaluation of Documentation

Upon receipt, the NIMH PO will review and evaluate the report, investigator’s description of the event, and any supporting documentation, and will consult with the NIMH Office of Clinical Research (OCR) as necessary.