The new Ethical eAdjudication® System can use cutting edge Ethereum blockchain technology to guarantee the integrity and reliability of information and Audit Trail.
Audit Trail and the Clinical Data Integrity Challenge
The development and manufacturing of pharmaceutical products is regulated by a set of rules called Good Practices (GxP) issued by the International Conference for Harmonization (ICH) and adopted by all regulatory agencies. In order to comply with GxP all data provided by pharmaceutical sponsor companies to the regulatory authorities must fulfil the ALCOAC rules (they must be Attributable - Legible - Contemporaneous - Original - Authentic and Complete). In order to guarantee compliance with these standards, any change to submitted data must be justified and documented. For this, validated computer systems are required to generate an Audit Trail recording all data introduced in the system and all actions performed during the use of the system. The Audit Trail must be created automatically, not be accessible or modifiable by any user of the system including administrators and be exportable in a “human readable” format for inspection. The Audit Trail guarantees the authenticity of the data but also serves as a trace of the processes followed and therefore of the compliance with standard operating procedures (SOP).
A bit of History (old and recent)
In the days when data were collected on paper, any change had to be crossed out in blue ink and signed/dated in a clearly legible way and carbon copies (one for the investigator, one for the sponsor) provided the necessary proof of integrity. With the move to electronic data capture (EDC) systems, data storage had to comply with the rules for electronic records (21 CFR part 11) and efforts were made to store all data in a single validated repository. The generalization of the internet drove data storage towards online servers hosted either by the sponsor or by a service provider (CRO, EDC vendor) and therefore under direct or indirect control of the sponsor company.
In spite of serious efforts to protect the data from accidental of intended modification (computer systems validation, 21 CFR part 11), recent cases of fraud in batch records by contract drug manufacturers (CMOs) have raised concerns with the regulators. The immediate remediation to such issues involved using paper or printing large files for archival but those solutions proved to be for the least inelegant.
Blockchain guarantees data integrity
Blockchain technology is a robust way of securing data. So robust that it is capable of supporting virtual currencies, such as the Bitcoin, without the need for banks, vaults, safes or keys. Imagine a list (like a spreadsheet) where, by nature, you can only write. Imagine that, in addition, every second, all new entries (anywhere in the world) are grouped (to form a block) and this block is then copied on a thousand different computers across the network (added to the chain). One can easily imagine that going back to change anything in such a setting is impossible. The data is safe and permanently stored in the blockchain.
Leveraging cutting edge technology to protect validation data and guarantee privacy
The Ethical eAdjudication® System was enabled to use different blockchain technology: Each time information is processed by the system, a unique signature (Hash) authenticates the Audit Trail entry and can be stored in a separate place, e.g. the Ethereum Blockchain. This process secures irrefutable evidence that data entered into the eAdjudication® System by any contributor has not been modified without a GxP audit trail stating reasons, time and originator of the change. The Ethereum blockchain does not process or store any information from the eAdjudication® System but only Hashvalues (code numbers) that can be used later to verify the data. Therefore, all data privacy and protection laws (e.g. GDPR, HIPAA) are respected.
