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The Secret of Study Conduct Documentation to ensure a successful Audit: What the FDA Inspectors look for Date: Tuesday, October 8, 2013 Duration:
60 Minutes
Time: 10:00 AM PDT | 01:00 PM EDT Location: Online
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Instructor: Charles H Pierce
Overview: All Clinical Research protocols have the procedures and processes needed to collect the data as it happens. The FDA guidelines and regulations for the conduct of research involving human subjects were developed to ensure complete and credible data and, of course, to safeguard the health and safety of human subjects.
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The Investigators role in the clinical research process The historical background of why accurate data is essential for ensuring safety of study participants / patients. The purpose of ensuring that all data is accurate, legible, contemporaneous, original and attributable The regulatory requirements for care of source documents What "To Do" with regard to data including corrections? What to "Never Do" with regard to data handling? What is the best time to review "Raw Data"? What documents does the FDA review - always? Learn who is responsible for "Data Management What is the history of the drug / device regulations?
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Principal Investigators and sub investigators Clinical Research Scientists (PKs, Biostatisticians, ...) Safety Nurses Clinical Research Associates (CRAs) and Coordinators (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 . ... more
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