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HCCA Research Compliance Conference

Sponsor Clinical Quality Assurance Audits of Investigator Sites: Readiness, Response, and CAPAs

1:00 PM CT – 2:00 PM CT

We are actively monitoring attendance. At random times throughout this session, you will be prompted with a pop-up to confirm that you are still actively participating in the virtual session. You will not see the pop ups if you are in full screen mode or your pop-up blocker is on. In addition, make sure you are disconnected from any VPN as they can also cause interference and that you have a stable internet connection (hard line is always best).Active attendance monitoring is only required if you will be requesting external CEUs for NASBA or CLE credits. If you only need Compliance Certification Board (CCB)® CEUs, it is not required to participate in active monitoring.

Learning Objectives:

  • Understand authority, purpose, and framework for sponsor CQA audit programs (including Investigator-Sponsors)
  • Discuss site audit readiness throughout study conduct and for the audit
  • Discuss audit process, sponsor observations, site responses, quality CAPAs


Shanley Curran
RM CQA, Fellow Boston Scientific

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