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Patil Divyashree Kantilal, Patil Bhagyshri Sandip, Patil Bhushan Ravindra, Patil Divyani Rajendra
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- Student M Pharm, Student M Pharm, Student M Pharm, Student M Pharm, P.S.G.V.P. Mandal’s Collage of Pharmacy, P.S.G.V.P. Mandal’s Collage of Pharmacy, P.S.G.V.P. Mandal’s Collage of Pharmacy, P.S.G.V.P. Mandal’s Collage of Pharmacy, Maharashtra, Maharashtra, Maharashtra, Maharashtra, India, India, India, India
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Abstract
nThe landscape of clinical research quality management has evolved significantly in recent years, driven by stringent regulatory frameworks and the globalization of trials. This evolution underscores the importance of integrating quality into all aspects of the clinical trial process, from design to post-research activities. Concepts such as Good Clinical Practice (GCP) and Quality by Design (QbD) are central to ensuring the reliability and accuracy of trial data while safeguarding patient safety and welfare. Challenges in quality assurance include the complexity of studies, the outsourcing of trial activities, and the need for continuous monitoring and improvement. The convergence of emerging technologies and evolving regulatory frameworks, complemented by collaborative endeavors among industry, academia, and regulatory bodies, is significantly influencing the trajectory of clinical research quality management. This collective effort aims to enhance the integrity, efficiency, and safety of clinical trials globally, fostering continual advancements in the field. Moving forward, integrated quality management plans, end-of-research reporting, and knowledge sharing will be key to advancing the quality and integrity of clinical trials worldwide.
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Keywords: Data integrity, Inspection, Quality systems, Risk-based monitoring, Subject protection.
n[if 424 equals=”Regular Issue”][This article belongs to Research & Reviews: A Journal of Drug Design & Discovery(rrjoddd)]
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References
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1. Center. First-of-kind Pediatric ECG Data Warehouse. U.S. Food and Drug Administration. Published 2024. Accessed April 2, 2024. https://www.fda.gov/drugs/spotlight-cder-science/first-kind-pediatric-ecg-data-warehouse-use-pediatric-product-development-programs-and-prevention
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Research & Reviews: A Journal of Drug Design & Discovery
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| Volume | 11 | |
| [if 424 equals=”Regular Issue”]Issue[/if 424][if 424 equals=”Special Issue”]Special Issue[/if 424] [if 424 equals=”Conference”][/if 424] | 01 | |
| Received | March 28, 2024 | |
| Accepted | April 4, 2024 | |
| Published | April 15, 2024 |
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