Data Safety & Monitoring Board

The Clinical and Translational Science Institute Data and Safety Monitoring Board monitors investigator-initiated studies.

NYU Langone’s Clinical and Translational Science Institute (CTSI) Data and Safety Monitoring Board (DSMB), which is composed of individuals who have appropriate expertise in topics relevant to the research being reviewed, provides oversight for NYU Langone investigator-initiated trials.

The board is responsible for the following tasks:

NYU Langone researchers may not use another DSMB for an NYU Langone investigator-held investigational new drug (IND) study without permission. However, cancer-related studies are expected to use the Data and Safety Monitoring Committee (DSMC) at NYU Langone’s Perlmutter Cancer Center. Other investigator-initiated trials (e.g., those that involve drug, device, surgical, and behavioral interventions) may be accepted for review by the CTSI Data and Safety Monitoring Board on a case-by-case basis.

We do not review studies that have previously been reviewed by another DSMB unless the researchers include a memo from the other board that describes the determination from the earlier review.

To learn more about our roles and responsibilities, please review the CTSI Data and Safety Monitoring Board Charter (Kerberos ID and password required).

Board Members

NYU Langone’s CTSI Data and Safety Monitoring Board is comprised of a multidisciplinary group of clinical investigators, an ethicist, and a biostatistician who are experts in clinical trial methodology and conduct. Additional members may also be appointed for specific studies (e.g., where specific expertise is required throughout the review of a given study).

• Anna Nolan, MD Chair, CTSI Data and Safety Monitoring Board Professor, Department of Medicine
• Elizabeth A. Raetz, MD. Member, CTSI Data and Safety Monitoring Board Chair, Division of Pediatric Hematology–Oncology The KiDS of NYU Foundation Professor of Pediatric Medicine, Department of Pediatrics
• Martin J. Sadowski, MD, PhD. Member, CTSI Data and Safety Monitoring Board Professor, Department of Neurology, Department of Psychiatry, and Department of Biochemistry and Molecular Pharmacology
• Erinn M. Hade, PhD Biostatistician, CTSI Data and Safety Monitoring Board Associate Professor, Biostatistics, Department of Population Health
• Alison Bateman-House, MPH, PhD Bioethicist, CTSI Data and Safety Monitoring Board Assistant Professor, Medical Ethics, Department of Population Health

Request Monitoring

We recommend that researchers engage the CTSI Data and Safety Monitoring Board early in the study protocol development process to ensure timely review and that your study protocol includes appropriate language.

To request monitoring of your study, please submit the CTSI Data and Safety Monitoring Board Monitoring Request Form. to ctsi-dsmb@nyulangone.org at least two weeks before our next meeting. We meet on the third Tuesday of each month at 3:30PM.

Submit Your Study Materials

After the CTSI Data and Safety Monitoring Board agrees to monitor a study, researchers are required to submit the following materials (in Microsoft Word format):

• study protocol
• data and safety monitoring plan (if not included in the study protocol)
• informed consent form

For review in a particular month, please send all materials to ctsi-dsmb@nyulangone.org by the second Tuesday of the month.

Report an Adverse Event

Principal investigators must use the CTSI Data and Safety Monitoring Board Serious Adverse Event Form. (Kerberos ID and password required) to report any of the following events:

• all adverse events that are serious and have a reasonable possibility of having been related to a study drug or study procedure
• all unexpected deaths
• any study-specific reporting requirements outlined in the study-specific DSMB Charter Addendum

Principal investigators must email this form to ctsi-dsmb@nyulangone.org within 24 to 48 hours of the study team learning of the adverse event.