MGB HRA Education: Sponsor-Investigator Responsibilities (IND/IDE/NSR)
April 25 @ 1:00 pm - 2:45 pm
This course is for sponsor investigators who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the test article/investigational device is administered, dispensed, or used. Course content is based on the ethical conduct of human research, Good Clinical Practice Guidelines, federal and state regulations, and institutional research policies. Although Investigators may be required to this comprehensive course as part of onboarding, it is also a great refresher for experienced investigators to ensure they are aware of the most current research regulations, institutional policies, and best practices for being a responsible Sponsor-Investigator.
Sample of Topics:
- Basic Information
- Relevant Policies and Regulations
- Responsibilities of Sponsor-Investigators
- Regulatory Inspections of Sponsor-Investigators
- Pamela Richtmyer – Director, MGB Human Research Affairs Compliance & Education Office
- Kathy Vernovsky – MGB Human Research Affairs Compliance & Education Office
- The “Sponsor-Investigator Responsibilities (IND/IDE/NSR)” training will be offered every other month through the MGB Human Research Affairs Compliance & Education Office. Future dates can be found here.
**This session will be held virtually. The link will be sent to those who register with a BWH/MGB-affiliated email address ~1 day prior to the session**