Review article on Quality Control in Clinical Trials

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nThis is an unedited manuscript accepted for publication and provided as an Article in Press for early access at the author’s request. The article will undergo copyediting, typesetting, and galley proof review before final publication. Please be aware that errors may be identified during production that could affect the content. All legal disclaimers of the journal apply.n

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Year : 2025 [if 2224 equals=””]26/08/2025 at 10:48 PM[/if 2224] | [if 1553 equals=””] Volume : 12 [else] Volume : [/if 1553] | [if 424 equals=”Regular Issue”]Issue : [/if 424][if 424 equals=”Special Issue”]Special Issue[/if 424] [if 424 equals=”Conference”][/if 424] 03 | Page :

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    Krishika Vinay jain, Sunila Patil, Amruta Patil,

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  1. B. Pharm, Student, B. Pharm, Student, B. Pharm, Student, Department of Pharmaceutical Science, P. S. G. V. P. Mandal’s College of Pharmacy, shahada, Associate Professor, Department of Pharmaceutical Chemistry, P. S. G. V. P. Mandal’s College of Pharmacy, shahada, Associate Professor, Department of Pharmaceutical Chemistry, P. S. G. V. P. Mandal’s College of Pharmacy, shahada, Maharashtra, Maharashtra, Maharashtra, India, India, India

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nQuality control (QC) is a critical component in the conduct of clinical trials, ensuring the accuracy, reliability, and credibility of data collected throughout the study. It encompasses a systematic set of procedures designed to monitor trial conduct and data integrity, thus safeguarding the rights, safety, and well-being of participants. This review explores the principles, implementation, and evolving practices of quality control in clinical trials, highlighting its importance across all phases of research. QC activities are implemented at multiple stages of a trial, beginning with protocol development and extending through data collection, data entry, monitoring, and final reporting. Key components include standard operating procedures (SOPs), staff training, site monitoring visits, data verification, audit trails, and centralized statistical monitoring. Proper QC helps ensure compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements, such as those set by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The effectiveness of quality control is increasingly supported by technological advancements, including electronic data capture (EDC) systems, risk-based monitoring, and real-time analytics. These tools allow early detection of protocol deviations, data inconsistencies, and potential fraud. Moreover, centralized monitoring approaches are gaining traction as a cost-effective complement to traditional on-site monitoring, enhancing QC efficiency without compromising data quality. Despite its significance, implementing robust QC strategies faces several challenges, such as resource constraints, variability across study sites, and the complexity of multinational trials. Addressing these challenges requires a proactive quality-by-design approach, integrating QC considerations early in trial planning and design. Collaboration among sponsors, clinical research organizations (CROs), investigators, and regulatory bodies is essential for fostering a culture of quality and continuous improvement. This review emphasizes the evolving role of quality control in ensuring scientific validity and ethical integrity in clinical trials. As regulatory expectations rise and trial designs become more complex, the demand for comprehensive, adaptive QC systems continues to grow. Future directions include greater integration of artificial intelligence, machine learning, and real-time dashboards to further enhance oversight and predictive quality metrics. Ultimately, robust quality control mechanisms are vital not only for regulatory approval but also for maintaining public trust in clinical research.nn

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Keywords: Clinical trials, quality control,audit trials, Documentation, patient safety , regulatory compliance, quality by design.

n[if 424 equals=”Regular Issue”][This article belongs to Research & Reviews: A Journal of Drug Design & Discovery ]

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[/if 424][if 424 equals=”Special Issue”][This article belongs to Special Issue under section in Research & Reviews: A Journal of Drug Design & Discovery (rrjoddd)][/if 424][if 424 equals=”Conference”]This article belongs to Conference [/if 424]

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nKrishika Vinay jain, Sunila Patil, Amruta Patil. [if 2584 equals=”][226 wpautop=0 striphtml=1][else]Review article on Quality Control in Clinical Trials[/if 2584]. Research & Reviews: A Journal of Drug Design & Discovery. 26/08/2025; 12(03):-.

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nKrishika Vinay jain, Sunila Patil, Amruta Patil. [if 2584 equals=”][226 striphtml=1][else]Review article on Quality Control in Clinical Trials[/if 2584]. Research & Reviews: A Journal of Drug Design & Discovery. 26/08/2025; 12(03):-. Available from: https://journals.stmjournals.com/rrjoddd/article=26/08/2025/view=0

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Volume 12
[if 424 equals=”Regular Issue”]Issue[/if 424][if 424 equals=”Special Issue”]Special Issue[/if 424] [if 424 equals=”Conference”][/if 424] 03
Received 07/08/2025
Accepted 20/08/2025
Published 26/08/2025
Retracted
Publication Time 19 Days

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