Clinical Research Coordinators and Site Owners Going To Jail? Darshan Kulkarni Explains! Ep.784
Random Musings From The Clinical Trials Guru
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Navigating Compliance and Confidentiality in Professional Communication
This chapter emphasizes the importance of selective responses in professional communication, maintaining confidentiality boundaries, and abiding by the Department of Justice's compliance program criteria. The discussion involves a case related to Bresinski, proactive healthcare compliance measures, and the challenges faced in clinical research sites, including the effectiveness of monitors. Additionally, it highlights the new safe harbor policy for self-disclosures in mergers and acquisitions, legal responsibilities in clinical research misconduct, and the significance of quality programs for site stability.
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