The roles and professional competencies of clinical study coordinators and data managers in clinical trials: A systematic review

Abstract

Background: The increasing methodological and regulatory demands of clinical trials have increased the need for clearly defined roles, particularly for Clinical Study Coordinators (CSCs) and Data Managers (DMs). While these professionals play crucial roles in the successful conduction of trials, the lack of established consensus on their profile, role, and responsibilities can lead to overlap and inefficiencies. This review aimed to identify the distinct roles of CSCs and DMs, examine their responsibilities, and explore the roles and responsibilities of CSCs and DMs and, when available, aspects of their collaboration.

Methods: We conducted a systematic review to analyze the distinct roles and responsibilities of CSCs and DMs. A literature search was performed in PubMed, CINAHL, Scopus, and Web of Science for primary studies published between 1 January 2000 and 30 September 2024. Eligible studies focused on defining CSC and DM roles, competencies, and professional responsibilities in clinical trials. Two independent reviewers screened articles, assessed methodological quality, and evaluated the risk of bias. The registration number is PROSPERO CRD42024599819.

Results: Of the 599 records identified, we included 10 studies. CSCs are responsible for the operational side of trials, including patient recruitment, regulatory compliance, and oversight of trial procedures. At the same time, DMs focus on ensuring data accuracy, integrity, and adherence to regulatory standards. The review highlighted the complementary nature of these roles, suggesting that future research could explore how collaboration between the roles may help maintain data quality and meet the demands of modern clinical research. However, the need for standardized role definitions and formal training programs was a significant challenge.

Discussion: This systematic review analyzes the roles of CSCs and DMs, emphasizing their complementary responsibilities in clinical trials. It highlights the need for structured training, standardized workflows, and certification programs to enhance efficiency, ensure regulatory compliance, and improve data quality.

Conclusion: Clarifying the roles of CSCs and DMs and implementing structured training and certification programs are essential to improving trial efficiency. While direct evidence of CSC-DM collaboration was limited, included studies indicate that clear role delineation enhances data quality and regulatory compliance.

Keywords: Clinical study coordinators; competencies; data managers; responsibility; systematic review.