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MGB HRA Education: Human Subjects Research Recordkeeping and Record Retention
January 6 @ 10:00 am - 11:30 am
This course is for investigators and all members of the study staff. It covers essential information regarding recordkeeping, documentation, and record retention requirements. Course content is based on the ethical conduct of human research, 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 recordkeeping requirements
- Paper versus electronic records
- Access to source documents and study files
- Regulatory binder and essential documents
- Subject files
- Regulations and policies
- Pamela Richtmyer – Director, MGB Human Research Affairs Compliance & Education Office
- Kathy Vernovsky – MGB Human Research Affairs Compliance & Education Office
- The Human Subjects Research Recordkeeping and Record Retention training will be offered monthly 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**