Responsibilities and Management of the Clinical Coordinating Center

Trinidad Ajazi ()
Additional contact information
Trinidad Ajazi: University of Chicago, Alliance for Clinical Trials in Oncology

Chapter 32 in Principles and Practice of Clinical Trials, 2022, pp 593-614 from Springer

Abstract: 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.

Keywords: Multi-site; Investigator-initiated; Clinical coordinating center; Clinical trial operations; Site management; Quality management; Regulatory compliance; Sponsor oversight; Research administration (search for similar items in EconPapers)
Date: 2022
References: Add references at CitEc
Citations:

There are no downloads for this item, see the EconPapers FAQ for hints about obtaining it.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-3-319-52636-2_274

Ordering information: This item can be ordered from
http://www.springer.com/9783319526362

DOI: 10.1007/978-3-319-52636-2_274

Access Statistics for this chapter

More chapters in Springer Books from Springer
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().