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Training the Investigatorship

In: Principles and Practice of Clinical Trials

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  • Claire Weber

    (Excellence Consulting, LLC)

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.

Suggested Citation

  • Claire Weber, 2022. "Training the Investigatorship," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 31, pages 583-591, Springer.
    • Handle: RePEc:spr:sprchp:978-3-319-52636-2_240
    DOI: 10.1007/978-3-319-52636-2_240
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