Clinical Research Coordinator Seminar Series: “Best Practices in Corrective and Preventative Action Plans”
This series provides current information necessary for the conduct of clinical research at Georgetown University, education and information on hot topics in clinical research, and regulatory updates.
Seminar Title: “Best Practices in Corrective and Preventative Action Plans”
Presented by:
Rose Ermete, RN, BSN, OCN, CRN-BC, CCRP
Senior Quality Assurance Nurse Auditor
SWOG Cancer Research Network
and
Deborah Grady, BSN, MS, CCRC
Quality Management Coordinator
National Cancer Institute
Abstract:
A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A critical component of a QMS is to have a Corrective and Preventive Action (CAPA) process. The process includes the plan to address a discrepancy or problem that has been found in the conduct of a clinical research study by identifying the root cause of the problem, implementing corrective action to prevent recurrence of the problem, and evaluating if the corrective action has resolved the problem. This presentation will assist you in understanding the CAPA process in your research team’s QMS.
Register for the series. (If you have not already registered for the Clinical Research Coordinator Series, click on the link provided and it will add the event and Zoom link [unique to you] to your calendar.)
Coordinated by the Office of Human Subject Protections