Selection of Study Centers and Investigators

Dikla Shmueli-Blumberg (), Maria Figueroa () and Carolyn Burke ()
Additional contact information
Dikla Shmueli-Blumberg: The Emmes Company, LLC
Maria Figueroa: The Emmes Company, LLC
Carolyn Burke: The Emmes Company, LLC

Chapter 12 in Principles and Practice of Clinical Trials, 2022, pp 191-207 from Springer

Abstract: Abstract Site and investigator selection has traditionally been the result of a comprehensive process by which a study sponsor and/or designated representative, often a contract research organization (CRO), evaluates prospective investigative teams and associated clinical sites for clinical trial participation. A list of criteria is often compiled and used by the sponsor to grade site and investigator suitability for study participation. In implementing a study, sponsors and site teams become partners in achieving study goals. For longer-term or complex studies, this partnership can become extensive. Sponsors and site teams must mutually invest in respective stakeholder perspectives and approaches to answer research questions. Site teams interested in the research question, with sufficient and qualified staff, and with access to the desired participant population, are key to conducting sound research. Sponsors that appreciate site perspectives, consider site operations and logistics in protocol design, support efforts to mitigate site challenges, communicate updates on broader perspectives of study activities, and offer fair compensation for site resources are key factors in implementing a successful study. Conversely, disconnected relationships between investigative teams and study sponsors can disrupt the timetable for research, contributing to compromised morale, cost overruns, and increased variability in administrating the protocol resulting in reduced ability to detect treatment differences, and may result in an unsuccessful trial. A site and investigator selection process should be designed to ensure that both sponsors and site teams thoroughly evaluate whether the protocol design, resources, sponsor/team relationships, general timelines, and site facilities are compatible in achieving the goals of the study.

Keywords: Site; Investigator; Sponsors; Investigator selection plan; Site selection; Recruitment; Investigator qualification; Investigative team; Qualification visit (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_35

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

DOI: 10.1007/978-3-319-52636-2_35

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 ().