The topics of this course include the following:
- Explain the regulatory requirements of research that involve drugs or devices.
- Determine whether use of a test article requires an IND/IDE or if it is IND/IDE exempt.
- Explain how to properly store and manage investigational drugs and devices that do not have any FDA-approved indications.
- Explain how to properly manage drugs and devices already under departmental oversight due to having an FDA-approved indication, but will be used off-label for research purposes.
- Discuss the regulatory requirements regarding the use of test articles in the clinical care setting.
Objectives
The objectives of this course include the following:
- Provide a regulatory framework for conducting human subjects research involving drugs and devices.
Speaker
Richard Ramdeo, CIP, and Khadijah Holley, MBA, from the Human Research Protection Program
The Public Research Education Program (PREP) is a series of courses developed by various research support offices in conjunction with other health system offices. The courses offer CME credits and are designed to increase quality of research throughout the health system and streamline the process of conducting research.
PREP courses also aim to enhance and expand investigator capacity to conduct research. PREP courses are free and open to all Northwell Health employees, students, and volunteers. In addition, interested research collaborators and community partners are welcome to attend.
Light refreshments will be served at the courses held at the Goldman B Conference Room.
Don’t forget to check out select videos of PREP courses online.
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