Research articleOpen accessVol. 7, Issue 7, June 2018
- Published
- 30 June 2018
- Licence
- CC BY 4.0
Abstract
Protocol deviations during clinical trials pose significant risks to data integrity, regulatory compliance, and participant safety. As the operational backbone of clinical research, trial managers are critical in enforcing protocol adherence and mitigating preventable deviations. This management study explores the strategic and operational roles of trial managers in averting protocol deviations, integrating perspectives from clinical trial governance, stakeholder coordination, quality assurance, and risk mitigation frameworks. Through a qualitative and comparative lens, the manuscript reviews literature and existing clinical practices to analyze the influence of proactive trial management on protocol compliance. The paper identifies mechanisms including site training, document tracking, centralized monitoring, and stakeholder engagement that trial managers utilize to detect and prevent deviations. The review highlights both systematic challenges and best practices across multicenter trials. The findings underline the importance of empowering trial managers with decision-making authority, standardized workflows, and real-time data visibility to foster protocol integrity across all study phases.
Keywords: Trial Manager, Protocol Deviation, Clinical Research, Risk Mitigation, Monitoring, Quality Management, SOP Compliance, Investigator Oversight, Site Coordination, Regulatory Adherence
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How to cite
Nishant Bora (2018). Role of Trial Managers in Preventing Protocol Deviations: A Management Study. International Journal for Research in Management & Pharmacy, 7(7).
Licence
This article is open access, published under the CC BY 4.0 licence. Copyright remains with the authors.