Scrybe: A Secure Audit Trail for Clinical Trial Data Fusion

Area of Science:

• Computer Science
• Biomedical Informatics
• Cybersecurity

Background:

• Clinical trials face significant challenges meeting regulatory requirements like 21 CFR Part 11 and ISO 27789.
• The increasing use of smart and wearable IoT devices in trials expands the attack surface and complicates data management.
• Existing Electronic Data Capture (EDC) and Clinical Data Management Systems (CDMS) are not equipped to handle these new data sources.

Purpose of the Study:

• To propose Scrybe, a permissioned blockchain solution for storing proof of clinical trial data provenance.
• To demonstrate how Scrybe addresses regulatory controls for electronic records.
• To evaluate the limitations of Ethereum-based blockchains for this application.

Main Methods:

• Development of Scrybe, a permissioned blockchain architecture.
• Analysis of Scrybe's alignment with 21 CFR Part 11 and ISO 27789 controls.
• Proof-of-concept integration of Scrybe with REDCap (Research Electronic Data Capture).

Main Results:

• Scrybe provides a robust mechanism for ensuring the provenance and tamper resistance of clinical trial data.
• The proposed blockchain addresses key audit requirements for electronic records, particularly with novel data sources.
• A proof-of-concept demonstrated successful integration and tamper-evident data storage with REDCap.

Conclusions:

• Scrybe offers a viable solution to enhance data integrity and regulatory compliance in clinical trials utilizing modern devices.
• Blockchain technology can effectively secure and validate electronic health records in research settings.
• Further research into blockchain applications for clinical trial data management is warranted.