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FDA Clinical Trial Auditing and the Due Diligence Companies Should Conduct as Part of their Monitoring Program Date: Tuesday, November 5, 2013 Duration:
90 Minutes
Time: 10:00 AM PDT | 01:00 PM EDT Location: Online
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Instructor: Charles H Pierce
Overview: The main principle is to follow exactly the signed and approved (IRB + PI) Protocol to the letter. This, in fact, is included on the FDA Form 1572. In the current regulatory climate, GCP Investigator site audits are a part of the clinical trail process. Sponsors should anticipate more inspections and information requests regarding monitoring practices.
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What doe the FDA look at when Auditing/Inspecting a study? The Sponsor's responsibility in monitoring study conduct Components of a sponsor monitoring system beyond SOPs The nature of adequate oversight of all staff and non-staff The importance of Protocol knowledge in preventing errors How do sites prepare for an audit / inspection The measures to ensure quality monitoring
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Senior Management Project Managers CRA Managers QA/Compliance persons Principal Investigators and sub investigators Clinical Research Scientists (PKs, Biostatisticians, ...) Safety Nurses Clinical Research Associates (CRAs) and Cordinators (CRCs) Recruiting staff QA / QC auditors and staff Clinical Research Data managers
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About Speaker Charles H Pierce Consultant, Clinical Research / Drug-Device Development Charles H Pierce MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. Dr. Pierce serves as an advisor to several clinical research organizations, sits on industry based boards, and is VP of Medical Affairs for Harrison Clinical Research GmbH, a global CRO headquartered in Munich. He has been in the Clinical Research Industry for 20 years, has been involved in developing Phase I & IIa Clinical Pharmacology Units... more
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