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MGB HRA Education: Recordkeeping and Record Retention Requirements

March 6 @ 1:00 pm - 2:30 pm




This MGB Human Research Affairs (HRA) course is for investigators and all members of the study staff and covers essential information regarding recordkeeping, documentation, and record retention requirements. Course content is based on the ethical conduct of human research, Good Clinical Practice (GCP) 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


Important Notes to Receive Credit:

  • Users taking this live (“webinar”) training are required to stay for the entire course duration and complete a knowledge check to receive credit.

— Attendance is tracked through Zoom and cross-referenced with registration in HealthStream. If users do not meet attendance requirements, then they will not receive a Certificate of Completion in HealthStream.

— Re-certification may be required by MGB HRA IRB or the MGB HRA Compliance & Education office.

  • This live (“webinar”) training is worth 1 RCR credit-hour toward Part 2 of the MGB RCR Requirements. You will have to stay for the entire training and complete the knowledge check to receive credit, as detailed above. The recorded (“on-demand”) version is not eligible for RCR credit.


Future Dates/Recorded Version:

— Future dates can be found on HealthStream or on our Brigham calendar.

— Search “MGB HRA” to find all courses.

— Please also see notes above on RCR credit.

  • The recorded (“on-demand”) version of this training is continuously available.

— The recorded (“on-demand”) version can be found on HealthStream.

— Search “MGB HRA” to find all courses.

— Please also see notes above on RCR credit.