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Responsibilities and Management of the Clinical Coordinating Center

In: Principles and Practice of Clinical Trials

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  • Trinidad Ajazi

    (University of Chicago, Alliance for Clinical Trials in Oncology)

Abstract

Clinical coordinating centers of investigator-initiated multi-site clinical trials have a myriad of responsibilities throughout the life cycle of clinical trials from trial concept development to completion. At the core of all clinical research is the dual mandate to protect human subjects and ensure trial data integrity. National regulations and international guidelines are designed to enable regulatory compliance and achievement of these mandates. Integrated within clinical coordinating center activities are quality management mechanisms designed to monitor, control, and assure patient safety and data integrity. This chapter summarizes the responsibilities of the clinical coordinating center with emphasis on efficient trial development and site selection, presents regulatory compliance requirements, focuses on practices for quality management, and describes clinical coordinating center management and network groups.

Suggested Citation

  • Trinidad Ajazi, 2022. "Responsibilities and Management of the Clinical Coordinating Center," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 32, pages 593-614, Springer.
    • Handle: RePEc:spr:sprchp:978-3-319-52636-2_274
    DOI: 10.1007/978-3-319-52636-2_274
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