MGB HRA Education: Inspections and Audits of Human Subjects Research

Summary:

This 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 Guidelines, federal and state research regulations, and institutional research policies. Although many research teams use this 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 research.

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

Speakers:

• Pamela Richtmyer – Director, MGB Human Research Affairs Compliance & Education Office
• Kathy Vernovsky – MGB Human Research Affairs Compliance & Education Office

Additional Details:

• The Clinical Research Inspections and Audits training will be offered 2x/year through the MGB Human Research Affairs Compliance & Education Office. Future dates can be found here.
• RCR Eligibility: Completion of this session fulfills 1 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**

REGISTER.