Data and Safety Monitoring

Data and Safety Monitoring is integral to good clinical research, by ensuring the safety of research participants and the integrity of research data consistent with NIH and FDA requirements.  Each clinical research protocol conducted in the intramural research program of NIH, is required to develop a data and safety monitoring plan, approved by the IRB, prior to study initiation.  The NINDS Clinical Trials Unit, supports and coordinates a central Data and Safety Monitoring Board, which includes members from within the intramural program as well as members external to the NIH, providing objective and unbiased review of safety and research data.  In addition, some protocols are best supported by an Independent Medical Monitor in addition to or in lieu of the central DSMB.  The IMM program is also directed by the NINDS Clinical Trials Unit.

Data and Safety Monitoring Entities:

Independent Medical Monitor (IMM)

The Independent Medical Monitor (IMM) is a physician or other clinician with relevant expertise whose primary responsibility is to provide independent safety monitoring in a timely fashion. The IMM performs contemporaneous review of adverse events as well as follow-up through resolution review. In addition, the IMM evaluates individual and cumulative participant data when making recommendations regarding the safe continuation of the study.

An IMM may be the sole monitor for the study or may perform this role complimentary of a Data and Safety Monitoring Board (DSMB).

Data and Safety Monitoring Board (DSMB)

A Data and Safety Monitoring Board (DSMB) is a formal, independent board of experts including investigators, bioethicists and biostatisticians that advise study investigators regarding the safe progression of a study. In general, NIH requires the establishment of DSMBs for multi-site clinical trials involving interventions that entail potential risk to the participants and for all Phase III clinical trials. As necessary, a DSMB may be appropriate for Phase I and Phase II or other clinical trials if, for example, the studies are blinded (masked), employ high-risk interventions, or involve vulnerable populations.  The board is permitted to make recommendations regarding trial design and conduct, but their primary charge is to advise the institute on the safety, efficacy, and scientific integrity of clinical trials.  The DSMB is governed by protocol specific charters.

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Data and Safety Monitoring
All FDA-regulated clinical trials must have a data and safety monitoring plan. 

Please email inquiries to Brandi Fields at Brandi.Fields@nih.gov.
 

Central DSMB Members

  • William Theodore, MD (DSMB Chair) Neurologist NIH/NINDS
  • Vikram Govindaraju Shakkottai, MD, PhD Neurologist UT Southwestern Medical Center
  • Lauren R. Sankary, JD, MA Bioethicist Cleveland Clinic Center for Bioethics
  • Paul J. Ford, Ph.D Bioethicist Cleveland Clinic Center for Bioethics
  • Alexis Simpkins, MD, PhD Neurologist Cedars-Sinai Medical Center
  • Tiffini Voss, MD Neurologist Passage Bio
  • Ninet Sinaii, PhD, MPH Statistician NIH Clinical Center
  • Xiaobai Li, PhD Statistician NIH Clinical Center
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Central DSMB Meetings


Meetings are scheduled for a 4-hour block.  A maximum of 4 protocols are reviewed during a meeting.

Ad hoc meetings can be scheduled as necessary.

The NINDS Central DSMB normally meets on the third Wednesday of every month between the hours of 1:00 pm to 5:00 pm.  Meeting dates are scheduled based on the availability of the central board.  A quorum of fifty percent is required to hold a meeting.

Central DSMB 2023 Meeting Dates
  • June 21, 2023
  • July 19, 2023
  • August 16, 2023
  • September 20, 2023
  • October 18, 2023
  • November 15, 2023
  • December 20, 2023
 

 

Important Documents