[PDF][PDF] Challenges and Solutions for Data Integrity in Clinical Trials Informatics

L Chan - 2023 - osf.io
Maintaining data integrity in clinical trials informatics is a critical challenge that directly
impacts the reliability and credibility of research outcomes. This paper explores the …

[PDF][PDF] Clinical Trial Efficiency through Data Integrity Controls

S Duggineni - International Journal of Science and Research, 2023 - researchgate.net
Clinical trial data management faces several challenges, including the need to collect and
manage large amounts of data from multiple sources, ensuring data quality and accuracy …

A blockchain framework for managing and monitoring data in multi-site clinical trials

O Choudhury, N Fairoza, I Sylla, A Das - arXiv preprint arXiv:1902.03975, 2019 - arxiv.org
The cost of conducting multi-site clinical trials has significantly increased over time, with site
monitoring, data management, and amendments being key drivers. Clinical trial data …

[HTML][HTML] Prototype of running clinical trials in an untrustworthy environment using blockchain

DR Wong, S Bhattacharya, AJ Butte - Nature communications, 2019 - nature.com
Monitoring and ensuring the integrity of data within the clinical trial process is currently not
always feasible with the current research system. We propose a blockchain-based system to …

TrialChain: A blockchain-based platform to validate data integrity in large, biomedical research studies

H Dai, HP Young, TJS Durant, G Gong, M Kang… - arXiv preprint arXiv …, 2018 - arxiv.org
The governance of data used for biomedical research and clinical trials is an important
requirement for generating accurate results. To improve the visibility of data quality and …

Tackling challenging data integrity topics in 2020: update on good clinical practice perspectives from the US FDA and MHRA UK

NA Khin, C Grandinetti, H Dixey, B Yu… - Clinical …, 2022 - Wiley Online Library
With the globalization of clinical trials, regulators have increased collaboration to evaluate
the adequacy of clinical trial conduct and to optimize regulatory oversight. The 2020 joint …

A blockchain framework for ensuring data quality in multi-organizational clinical trials

O Choudhury, I Sylla, N Fairoza… - 2019 IEEE International …, 2019 - ieeexplore.ieee.org
The cost and complexity of conducting multi-site clinical trials have significantly increased
over time, with site monitoring, data management, and Institutional Review Board (IRB) …

[HTML][HTML] Blockchain compliance by design: Regulatory considerations for blockchain in clinical research

W Charles, N Marler, L Long, S Manion - Frontiers in Blockchain, 2019 - frontiersin.org
As clinical research moves toward real-world data capture with increased data sharing,
there is a growing need for patient-centered technologies that ensure data authenticity and …

[HTML][HTML] Ensuring protocol compliance and data transparency in clinical trials using Blockchain smart contracts

IA Omar, R Jayaraman, K Salah… - BMC Medical Research …, 2020 - Springer
Abstract Background Clinical Trials (CTs) help in testing and validating the safety and
efficacy of newly discovered drugs on specific patient population cohorts. However, these …

[PDF][PDF] Risk-Based Monitoring and Data Integrity in Clinical Research

S Duggineni - International Journal of Science and Research, 2020 - researchgate.net
Today's clinical trials landscape is being shaped by macro trends that include the Covid-19
pandemic, geopolitical uncertainty, and climate pressures. Meanwhile, advancements in …