MGB HRA Education: Clinical Research Bootcamp
April 5 @ 10:00 am - 12:30 pm
The Clinical Research Boot Camp course is a “clinical research 101” for investigators and all members of the study staff. Course content is based on Good Clinical Practice Guidelines, federal and state research regulations, and institutional research policies. Although many research teams require this comprehensive course as part of onboarding, it is also a great refresher for experienced members of the study team to ensure they are aware of the most current research regulations, institutional policies, and best practices for conducting clinical research.
Sample of Topics:
- Basic Human Subjects Research Information
- Principal Investigator Responsibilities
- Informed Consent of Research Subjects
- Essential Documents, Regulatory Binder, and Subject Files
- Deviations, Unanticipated Problems, Adverse Events, and Exceptions
- Investigational Product Accountability and Storage
- Miscellaneous Things You Need to Know: HIPAA and Privacy, Specimen Management, Transfer Agreements, Clinical Trials.gov, Monitor Access to Epic
- Audits and Inspections of Clinical Research
- Available Resources
- Pamela Richtmyer – Director, MGB Human Research Affairs Compliance & Education Office
- Kathy Vernovsky – MGB Human Research Affairs Compliance & Education Office
- The Clinical Research Bootcamp will be offered 1-2 times per month through the MGB Human Research Affairs Compliance & Education Office. Future dates can be found here.
- RCR Eligibility: Completion of this session fulfills 2 of the 4 hours outlined in part 3 of the RCR requirement.
**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**