Research Regulatory Services
The Research Regulatory Services team at NYU Langone provides support for research that involves human subjects or investigational drugs and devices.
Our Quality Assurance and Quality Improvement Division conducts routine and for-cause audits of human subject research studies (Kerberos ID and password required) at, or on behalf of, NYU Langone Health and its affiliates. These audits ensure that the rights and welfare of human research participants are protected and in compliance with federal regulations, state laws, and institutional policies.
This level of post-approval oversight promotes continuing education for research personnel and supports operational awareness of and quality improvement consistent with NYU Langone’s Human Research Protection Program. We also provide information on how to maintain study documents in a regulatory binder (Kerberos ID and password required).
Our Regulatory Support Unit helps researchers register studies, submit updates, and publish findings on clinicaltrials.gov in compliance with requirements from the U.S. Food and Drug Administration (FDA), National Institutes of Health, and International Committee of Medical Journal Editors. We also assist investigators who have an investigational new drug application or investigational device exemption study drugs or devices that are not FDA approved.
David Wallach, MPH, CIP
Director of Research Regulatory Services
Jayne Kim, PhD
Research Regulatory Manager
Judy Kwak, MA, CIP
Susanna Zavlunova, MD, CCRP
Quality Assurance and Improvement Specialist
Sara Saeed, MS
Research Regulatory Specialist