Training the Investigatorship

Claire Weber ()
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Claire Weber: Excellence Consulting, LLC

Chapter 31 in Principles and Practice of Clinical Trials, 2022, pp 583-591 from Springer

Abstract: Abstract The Investigatorship for clinical trials is a team with specialized experience who are qualified by training and experience to successfully execute clinical trials. The Investigatorship includes the trial sponsor, Good Clinical Practice (GCP) Contract Service Providers (CSPs), and site Investigators, who may also include outside experts such as Key Opinion Leaders (KOLs) and Data Monitoring Boards (DMBs). GCP is the fundamental required training for all team members conducting clinical trials. Training occurs throughout the lifecycle of the trial, and each member of the team must have records of adequate training and qualifications to conduct the study for their identified role. This chapter explains the Investigatorship members, the types of training conducted, and how training is documented.

Keywords: Documentation; Monitoring; Delegation; File; Quality system (search for similar items in EconPapers)
Date: 2022
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Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-3-319-52636-2_240

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DOI: 10.1007/978-3-319-52636-2_240

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