Sponsor Clinical Quality Assurance Audits of Investigator Sites: Readiness, Response, and CAPAs
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Carole Klove, General Counsel and Chief Nursing Officer, Elemeno Health.
2022-06-08
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Understand authority, purpose, and framework for sponsor CQA audit programs (including Investigator-Sponsors)
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Discuss site audit readiness throughout study conduct and for the audit
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Discuss audit process, sponsor observations, site responses, quality CAPAs
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