The Clinical Research Podcast Series at NYU Langone Health
For this episode we have Dr. Chau Trinh-Shevrin here. Dr. Trinh-Shevrin is a professor for the NYU Langone Health Depts of Population Health and Medicine, Section for Health Equity, Vice Chair for Research in the Department of Population Health, and serves as chair for the NYU Langone Health Institutional Review Board. She joins our host, Robert Maril, MM, CIP, for a discussion about the her experience as an IRB member, advice for researchers and more. Host: Robert Maril, MM, CIP, Senior Scientific Manager, NYU Langone Human Subjects Protections Producer: Royell...
info_outlineThe Clinical Research Podcast Series at NYU Langone Health
Clinical trials often require the use of a data and safety monitoring board (DSMB) but understanding the role of DSMB in human subjects research can be confusing for some. Dr. Erinn Hade highlights NYU Langone Health’s Clinical and Translational Science Institute (CTSI) Data and Safety Monitoring Board (DSMB). In a recent discussion with Dr. Hade, HRP’s Robert Maril helped get some clarity on DSMBs. Dr. Hade shared her insights regarding the role of a DSMB in human subjects research including the services CTSI provides in support of DSMBs, the review process, submission requirements and...
info_outlineThe Clinical Research Podcast Series at NYU Langone Health
With a growing number of multisite human research studies requiring the use of the NYU Langone Health IRB as the single IRB (sIRB) of record, in addition to studies that require institutional clearance when using an External IRB, a new unit, the External Review Unit has emerged into the Human Research Protection area to manage the work related to these 2 work flows.
info_outlineThe Clinical Research Podcast Series at NYU Langone Health
Listen to hear about about required certification and all available resources to help you prepare High quality submissions and maintain regulatory compliance.
info_outlineThe Clinical Research Podcast Series at NYU Langone Health
The inner workings of the Institutional Review Board (IRB) at times may seem like a mystery. In this episode, you will hear directly from IRB chairs, Frederick More, DDS, MS, and Alexes Hazen, MD, FACS and member Samuel Bliss, PharmD. Together, they discuss their experiences serving on the IRB, their role in the overall review process, and their advice for human subjects researchers.
info_outlineThe Clinical Research Podcast Series at NYU Langone Health
This episode covers the Association of Clinical Coordination & Research Management (ACCRM), an internal NYU organization created by study team members to improve research processes across the health system.
info_outlineThe Clinical Research Podcast Series at NYU Langone Health
This episode focuses on the creation and implementation of the Clinical Research Coordinator (CRC) Foundational Program, a two day, instructor-led course that covers essential topics for research study team success.
info_outlineClinical trials often require the use of a data and safety monitoring board (DSMB) but understanding the role of DSMB in human subjects research can be confusing for some. Dr. Erinn Hade highlights NYU Langone Health’s Clinical and Translational Science Institute (CTSI) Data and Safety Monitoring Board (DSMB). In a recent discussion with Dr. Hade, HRP’s Robert Maril helped get some clarity on DSMBs. Dr. Hade shared her insights regarding the role of a DSMB in human subjects research including the services CTSI provides in support of DSMBs, the review process, submission requirements and reporting responsibilities of investigators.
Dr. Erinn Hade is an Associate Professor of Biostatistics in the Department of Population Health at NYU Grossman School of Medicine. She is also a researcher, a trial statistician, and a member of the NYU Langone Health CTSI DSMB.
Discussion Breakdown:
0:44 - When the NYU Langone Health CTSI Data and Safety Monitoring Board (DSMB) started?
1:00 - NYU Langone Health created its own DSMB
1:53 - The difference between and IRB and a DSMB
4:23 - DSMB Composition
6:14 - When researchers should connect with the DSMB regarding their human subjects’ research
8:59 - When use of the CTSI DSMB is required
10:27 - The DSMB review process and submission requirements for new studies
12:29 - Interim safety data reporting requirements
15:15 - How the DSMB member experience has impacted Erin’s own research
17:09 - Advice on developing data and safety monitoring plan (DSMP)
18:51 - Resources for DSMP development
20:30 - What the CTSI DSMB has in store for the future
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