Notice Number: NOT-MH-15-025

Key Dates
Release Date: July 22, 2015

Issued by
National Institute of Mental Health (NIMH)

Purpose

NIMH has published updated policies and guidance for investigators conducting NIMH-funded clinical research.

The September 2007 NIMH Policy on Data and Safety Monitoring in Clinical Trials has been updated and renamed as the NIMH Policy Governing the Monitoring of Clinical Trials. The revised policy explains the need for a clear and well-developed data and safety monitoring plan (DSMP), highlights the critical elements of a DSMP, and outlines the appropriate levels of monitoring for a clinical trial. The NIMH Policy Governing the Monitoring of Clinical Trials can be found at: http://www.nimh.nih.gov/funding/clinical-research/nimh-policy-governing-the-monitoring-of-clinical-trials.shtml.

In conjunction with the update on Policy Governing the Monitoring of Clinical Trials, we are further clarifying NIMH policy on the use and description of Independent Safety Monitors (ISM) and Independent Data and Safety Monitoring Boards (DSMB). This policy clarifies expectations for the monitoring of NIMH-supported clinical trials by ISMs and/or DSMBs to assure the safety of research participants, regulatory compliance, and the data integrity. Specifically, the policy addresses roles and membership, independence, responsibilities and review, review schedule and monitoring reports. The Policy Governing Independent Safety Monitors and Independent Data and Safety Monitoring Boards can be found at: http://www.nimh.nih.gov/funding/clinical-research/policy-governing-independent-safety-monitors-and-independent-data-and-safety-monitoring-boards.shtml.

Finally, the NIMH has posted an additional policy related to "Reportable Events" in clinical research. The Reportable Events Policy outlines 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)), Data and Safety Monitoring Board (DSMB); and suspensions or terminations by regulatory agencies (e.g., Office for Human Research Protections (OHRP) or the Food and Drug Administration (FDA)). The Reportable Events Policy can be found at: http://www.nimh.nih.gov/funding/clinical-research/nimh-reportable-events-policy.shtml.

To assist investigators and applicants, the NIMH has also developed two guidance documents to help researchers to ensure the safety of research participants and protect the validity and integrity of study data in clinical trials supported by the NIMH:

• The Guidance on Risk-Based Monitoring clarifies risk level definitions and the NIMH’s monitoring expectations to mitigate those risks. The guidance specifically identifies three levels of risk (minimal risk, greater than minimal risk, and significantly greater than minimal risk) and establishes monitoring recommendations for each. The Guidance on Risk-Based Monitoring can be found at: http://www.nimh.nih.gov/funding/clinical-research/nimh-guidance-on-risk-based-monitoring.shtml.
• The Data and Safety Monitoring Plan Writing Guidance assists researchers in developing a data and safety monitoring plan (DSMP) by highlighting key considerations for determining the appropriate level of monitoring and the critical elements of an acceptable DSMP. The Data and Safety Monitoring Plan Writing Guidance can be found at: http://www.nimh.nih.gov/funding/clinical-research/data-and-safety-monitoring-plan-writing-guidance.shtml.

Clinical research policies, guidance, and resources can be found on the NIMH Clinical Research website: http://www.nimh.nih.gov/funding/clinical-research/index.shtml

Inquiries

Please direct all inquiries to:

Nitin Gogtay, M.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3241
Email: HRPB@mail.nih.gov
Website: http://www.nimh.nih.gov/about/organization/od/office-of-clinical-research-ocr.shtml