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TBase - an Integrated Electronic Health Record and Research Database for Kidney Transplant Recipients

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Blockchain as a Prime Guardian: Securing Clinical Trial Data Integrity.

Nikhil Sethi¹, Charul Rathore¹, Dilpreet Singh¹

¹University Institute of Pharma Sciences, Chandigarh University, Gharuan, Mohali, 140413, India.

Reviews on Recent Clinical Trials

|January 24, 2025

Summary

Blockchain technology enhances clinical trial data security and integrity. It ensures transparency, prevents data tampering, and improves regulatory oversight for reliable trial outcomes.

Keywords:

Blockchain data integrity data management decentralization smart contracts.transparency

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Area of Science:

Health Informatics
Information Security
Clinical Research

Background:

Clinical trials face increasing complexity and international scope, necessitating robust data management.
Ensuring data quality, integrity, transparency, and legal compliance is paramount in modern clinical investigations.

Purpose of the Study:

To explore the application of blockchain technology for secure data management in clinical trials.
To address challenges in data revisions, selective data release, and compliance auditing.

Main Methods:

Review of blockchain's features: distributed, immutable, time-stamped ledger.
Analysis of blockchain's potential for multi-center study surveillance and patient confidentiality.
Examination of blockchain's role in internal accountability and bias avoidance in outcome reporting.

Main Results:

Blockchain offers a secure and transparent platform for clinical trial data management.
Immutable records enhance internal accountability and prevent data alteration.
Facilitates unbiased reporting of all trial outcomes, both positive and negative.

Conclusions:

Blockchain technology can significantly improve the validity and reliability of clinical trial data.
Digital ledger technology provides a robust solution for reputation management in clinical research.
Blockchain adoption is recommended for enhanced data security and regulatory compliance in clinical trials.