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MGB HRA Education: Clinical Research Bootcamp

February 7 @ 1:00 pm - 3:00 pm

CLICK HERE TO REGISTER via HealthStream

 

Summary:

This MGB Human Research Affairs (HRA) course is a comprehensive human subjects research training course for investigators and all members of the study staff. Course content is based on the ethical principles of human research protections, Good Clinical Practice (GCP) Guidelines, federal and state research regulations, institutional research policies, and reflects the 2018 Requirements of the Common Rule. The principles established in the content of the course are applicable to all human research investigations. The content supports the protection of the rights, safety, and well-being of human participants and provides learners with the skills for applying the Belmont Report Principles and associated policies and regulations in common research practices.

This training is required for all involved in MGB/BWH Human Subjects Research. Read more here.

 

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, 21 CFR part 11
  • Audits and Inspections of Clinical Research
  • Available Resources

 

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.

 

CLICK HERE TO REGISTER via HealthStream