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  Published Paper Details:

  Paper Title

Developing and Standardizing Data Management Standard Operating Procedures (SOPs) for Clinical Trials.

  Authors

  Lakshmi Priya Darshini Pulavarthi

  Keywords

Clinical Trials; Data Management; Standard Operating Procedures; Regulatory Compliance; SOP Standardization; Clinical Trial Efficiency; Quality Management; Decentralized Trials; Artificial Intelligence in Trials

  Abstract


As clinical trials continue to expand in complexity, scale, and digital transformation, the role of data management Standard Operating Procedures (SOPs) has become more crucial than ever. SOPs serve as the backbone of trial conduct, ensuring consistent data processes, regulatory compliance, and high-quality outputs across diverse trial settings. This review presents a comprehensive synthesis of literature related to SOP development, highlights frameworks and experimental findings, and proposes a theoretical model for SOP standardization. Key performance data indicates that harmonized SOPs significantly enhance data integrity, protocol adherence, and audit readiness. Additionally, we explore how technological advancements--especially artificial intelligence and decentralized trials--are reshaping SOP paradigms. By critically evaluating current practices and emerging trends, this article provides practical and strategic insights into the future of SOPs in clinical trial data management.

  IJCRT's Publication Details

  Unique Identification Number - IJCRT25A6277

  Paper ID - 292995

  Page Number(s) - k959-k968

  Pubished in - Volume 13 | Issue 6 | June 2025

  DOI (Digital Object Identifier) -   

  Publisher Name - IJCRT | www.ijcrt.org | ISSN : 2320-2882

  E-ISSN Number - 2320-2882

  Cite this article

  Lakshmi Priya Darshini Pulavarthi,   "Developing and Standardizing Data Management Standard Operating Procedures (SOPs) for Clinical Trials.", International Journal of Creative Research Thoughts (IJCRT), ISSN:2320-2882, Volume.13, Issue 6, pp.k959-k968, June 2025, Available at :http://www.ijcrt.org/papers/IJCRT25A6277.pdf

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ISSN: 2320-2882
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Journal Starting Year (ESTD) : 2013
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ISSN and 7.97 Impact Factor Details


ISSN
ISSN
ISSN: 2320-2882
Impact Factor: 7.97 and ISSN APPROVED
Journal Starting Year (ESTD) : 2013
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