Clinical Research Coordinators and Site Owners Going To Jail? Darshan Kulkarni Explains! Ep.784
Random Musings From The Clinical Trials Guru
Importance of Audits and Compliance in Clinical Research Sites
This chapter emphasizes the significance of audits, compliance programs, and quality improvement processes in clinical research sites. It discusses the necessity of adherence to laws and regulations, training for compliance leadership, and the role of incentives tied to performance. The speakers also delve into handling compliance issues with the FDA, risk assessment, and maintaining confidentiality while addressing violations.
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