ISSN2320-2882
Impact Factor9.17
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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.

How To Cite

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IJCRT — journal style
"Developing and Standardizing Data Management Standard Operating Procedures (SOPs) for Clinical Trials.", IJCRT - International Journal of Creative Research Thoughts (www.ijcrt.org), ISSN:2320-2882, Vol.13, Issue 6, page no.k959-k968, June 2025, Available :https://ijcrt.org/papers/IJCRT25A6277.pdf
APA — 7th edition
Pulavarthi, L. P. D. (2025). Developing and Standardizing Data Management Standard Operating Procedures (SOPs) for Clinical Trials. International Journal of Creative Research Thoughts, 13(6), k959-k968. https://ijcrt.org/viewpaperforall.php?paper=IJCRT25A6277
MLA — 9th edition
Pulavarthi, Lakshmi Priya Darshini. "Developing and Standardizing Data Management Standard Operating Procedures (SOPs) for Clinical Trials." International Journal of Creative Research Thoughts, vol. 13, no. 6, 2025, pp. k959-k968, https://ijcrt.org/viewpaperforall.php?paper=IJCRT25A6277.
Chicago — 17th, bibliography
Pulavarthi, Lakshmi Priya Darshini. "Developing and Standardizing Data Management Standard Operating Procedures (SOPs) for Clinical Trials." International Journal of Creative Research Thoughts 13, no. 6 (2025): k959-k968. https://ijcrt.org/viewpaperforall.php?paper=IJCRT25A6277.
Harvard — author–date
Pulavarthi, L.P.D. (2025) 'Developing and Standardizing Data Management Standard Operating Procedures (SOPs) for Clinical Trials', International Journal of Creative Research Thoughts, 13(6), pp. k959-k968. Available at: https://ijcrt.org/viewpaperforall.php?paper=IJCRT25A6277
IEEE — numbered reference
L. P. D. Pulavarthi, "Developing and Standardizing Data Management Standard Operating Procedures (SOPs) for Clinical Trials," IJCRT, vol. 13, no. 6, pp. k959-k968, Jun. 2025.
Vancouver — biomedical
Pulavarthi LPD. Developing and Standardizing Data Management Standard Operating Procedures (SOPs) for Clinical Trials. IJCRT. 2025 Jun;13(6):k959-k968.
AMA — 11th edition
Pulavarthi LPD. Developing and Standardizing Data Management Standard Operating Procedures (SOPs) for Clinical Trials. IJCRT. 2025;13(6):k959-k968. Accessed at https://ijcrt.org/viewpaperforall.php?paper=IJCRT25A6277
BibTeX — Zotero, Mendeley, LaTeX
@article{IJCRT25A6277, author = {Lakshmi Priya Darshini Pulavarthi}, title = {Developing and Standardizing Data Management Standard Operating Procedures (SOPs) for Clinical Trials.}, journal = {International Journal of Creative Research Thoughts}, volume = {13}, number = {6}, pages = {k959-k968}, year = {2025}, month = {June}, issn = {2320-2882}, url = {https://ijcrt.org/viewpaperforall.php?paper=IJCRT25A6277} }
RIS — EndNote, RefWorks
TY - JOUR AU - Pulavarthi, Lakshmi Priya Darshini TI - Developing and Standardizing Data Management Standard Operating Procedures (SOPs) for Clinical Trials. T2 - International Journal of Creative Research Thoughts JA - IJCRT VL - 13 IS - 6 PY - 2025 SN - 2320-2882 UR - https://ijcrt.org/viewpaperforall.php?paper=IJCRT25A6277 SP - k959-k968 ER -

Issue

Volume 13 Issue 6, June-2025
Pages : k959-k968

Article Information

Pages
k959-k968
Published
June 2025
Registration ID
IJCRT_292995
Published Paper ID
IJCRT25A6277
Research Area
Science and Technology
Author Type
Indian Author
Location
India
Licence
CC BY 4.0 · Open Access
ISSN & Impact Factor
2320-2882 · IF 9.17
Downloads
272

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Registration ID IJCRT_292995

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International Journal of Creative Research Thoughts Published by IJCRT Publication
2320-2882 ISSN
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Impact Factor 9.17, calculated from Google Scholar citation data — see how it is worked out.
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Licence

© 2025 — Authors hold the copyright of this article. This work is licensed under a Creative Commons Attribution 4.0 International License and The Open Definition. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (CC BY 4.0), which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited.
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Declarations

Funding

No external funding was received for this study.

Conflict of Interest

The authors declare that they have no conflict of interest.

Acknowledgements

The authors would like to thank the reviewers and the editorial board of International Journal of Creative Research Thoughts for their careful reading and constructive comments, and all colleagues who supported the preparation of this manuscript.

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