Dawn Niccum 21 Jun 2023 ASQ VIRTUAL 6PM Presentation

Wednesday, Jun 21, 2023 VIRTUAL 6PM Presentation

Dawn Niccum, MSN

Dawn Niccum, MSN – Vice President QA, inSeption Group

“Day in the Life” of Clinical QA in Clinical Trials

The pillars of quality in clinical research centers are data integrity and human subject protection. Clinical Quality Assurance serves both as the typical auditor and independent role, but also as the compliance advisor and partner to the clinical team. Good Clinical Practice (GCP) regulations have no requirement for a QA department which makes the role of CQA a more flexible one.

In this presentation, we will explore the role of the Clinical QA professional in ensuring that all activities are done to ensure the data integrity of the trial data and the rights, welfare, and safety of trial participants.

Dawn Niccum

Dawn Niccum is the Executive Vice President, QA and Compliance for inSeption Group. inSeption Group is a global outsourcing provider in the clinical trial space. Dawn has been involved in clinical research for over 30 years in roles including study coordinator, site monitor/CRA, training, compliance, and quality assurance. She holds degrees in Nursing (BS), Regulatory Affairs (MS), and Nursing Education (MSN). She has certifications in clinical quality assurance (RQAP-GCP), clinical research (CCRA), and project management (PMP).

ASQ St. Louis Section Monthly VIRTUAL Presentation

Wednesday, Jun 21, 2023
6:00 PM – 07:00 PM Central

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