A 2-day, CEU/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 training on the nuts and bolts of conducting clinical research. 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 2-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 (GCP) in research. Completion of Day 1 or a Navigating Clinical Research Class prior to 2015 is required in order to attend Day 2.
DAY 1 is beneficial for everyone involved in clinical research and offers training on the basics. It covers fundamentals of conducting research, available research support services, grants process, IRB policies and procedures, and research billing.
DAY 2 is beneficial for those involved in clinical trials with investigational products, such as drugs and devices. It offers in-depth training on GCP and covers conducting quality research, good documentation practices, understanding the randomization process, and management of investigational drugs.
The completion of both days is an option to satisfy health system GCP training requirements for those involved in sponsor-investigator trials. In addition, effective as of January 30, 2015, our 2-day Navigating Clinical Research Class has been approved as an ICH E6 GCP Investigator Site Training that meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma Inc. as necessary to enable mutual recognition of GCP training among trial sponsors. Mutual recognition of GCP training by trial sponsors reduces the burden of unnecessary duplicate training for investigators. More information about TransCelerate’s GCP Training Mutual Recognition Program can be found at www.transceleratebiopharmainc.com/gcp-training-attestation/.
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 the Office of Research Policy and Training at RPT@nshs.edu with any questions.
Please click here to get directions to the Center for Learning and Innovation (CLI).