A one-day, CME-accredited class that provides experienced and novice investigators as well as research professionals with the tools and guidance they will need to be compliant and scientifically, operationally, and fiscally responsible while conducting research at the Health System.
In support of the Health System’s core mission to improve treatment and the delivery of care by advancing research, the Feinstein Institute provides education on the nuts and bolts of conducting clinical research. Clinical Research is governed by a patchwork of federal, state, and increasingly international regulations and guidance such as, but not limited to, FDA regulations at 21 CFR Parts 50, 56, 312, 812; HIPAA and HITECH requirements at 45 CFR Part 164; OHRP regulations at 45 CFR 46; and International Conference on Harmonization (ICH) Topic E6. This class empowers and equips investigators and research professionals with the knowledge and tools to navigate through this daunting regulatory environment, with an aim to foster success in their research careers at the Health System.
Integrated within this one day class are interactive activities such as current case studies where students are able to relate to real life scenarios to understand core concepts for good clinical practice in research. Instructors from the various research support offices including Research Administration, the Human Research Protection Program/Institutional Review Board, the Office of Research Compliance, the Clinical Research Service, and the Grants Management Office encourage in-depth discussion.
This class is offered quarterly at the Center for Learning and Innovation (CLI). Registration is required through iLearn; course dates, agenda, and materials can be found on iLearn. The class is free to Health System employees. Contact Tina Chuck at firstname.lastname@example.org or 516-321-2104 with any questions.
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