MGB HRA Education: Inspections and Audits of Human Subjects Research

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Summary:

This MGB Human Research Affairs (HRA) course is for investigators and all members of the study staff and covers essential information regarding audits and inspections, common findings, how to prepare and how to respond. Course content is based on the ethical conduct and oversight of human research, Good Clinical Practice (GCP) Guidelines, federal and state research regulations, and institutional research policies.

Sample of Topics:

• Overview of Compliance and Education Office
• Audits and Inspections-What are they? Why are they done?
• Audits and Inspections-What happens? What is the scope?
• How to prepare for Audits and Inspections
• Common Audit and Inspection findings
• What to do after an audit or inspection is concluded
• 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:

• The live (“webinar”) version of this training will be offered 2x/year through the MGB Human Research Affairs (HRA) Compliance & Education Office.

— 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.

REGISTER via HealthStream