Blockchain-based Documentation for Clinical Trials
Sector: Tertiary sector · Industry: Research institutes · Organisation: Benchoufi, Porcher & Ravaud (Forschungsteam) · Maturity level: Concept
The research team of Benchoufi, Porcher, and Ravaud has developed a proof-of-concept protocol that uses blockchain technology for secure and transparent documentation of informed consent in clinical trials. The system employs ChainScript for timestamping and storing all relevant interactions such as investigator uploads, email requests, and participant signatures. The solution aims to improve traceability and prevent manipulation in consent collection processes.
Documentation status
- Project status: Concept
- Evidence: Evidence high
- Editorial review: Ufuk Avci, 15 April 2026
Description
Clinical trials face several integrity issues: (1) Protocol changes after the study starts can adjust hypotheses to fit results (HARKing — Hypothesizing After Results are Known). (2) Negative results are rarely published. (3) Informed consents can be altered retrospectively. Blockchain timestamps structurally solve these problems: once entered, the study protocol is immutably dated.
Mehdi Benchoufi, Raphaël Porcher and Philippe Ravaud published in 2017 in F1000Research the first academic proof that blockchain technology can be used for tamper-proof documentation of patient consents in clinical trials. The approach: Ethereum blockchain for time-stamped consents. The patient consent (Informed Consent) is digitally signed and anchored as a hash on the blockchain. Any change to the consent is stored as a new transaction linked to the previous state — fully auditable. In 2019, a more comprehensive paper followed in Frontiers in Blockchain: "Blockchain for improving the transparency of clinical trials." The reproducibility crisis in science (50–70% of published studies not reproducible) could be significantly reduced by blockchain-based protocol preregistration: the difference between reported and originally hypothesised endpoints would be immediately verifiable.
Perspectives
B2B — organisations perspective
Pharmaceutical companies, CROs and academic research institutions can better meet regulatory transparency requirements (FDA, EMA) with blockchain-based study protocols and strengthen trust in clinical results.
B2C — consumers perspective
Patients gain the assurance that their consent is immutably documented and cannot be tampered with afterwards through blockchain-secured consent documents.
Employees perspective
Study coordinators and researchers benefit from reduced manual documentation tasks and automated compliance checks. At the same time, they must adapt to new digital workflows and acquire basic knowledge of blockchain technology.
Benefits
General
- The immutable blockchain documentation eliminates the risk of retrospective manipulation of consent forms.
- Automated timestamping of all process steps creates a seamless audit trail for compliance reviews.
- Increased transparency and traceability strengthen the trust of patients and regulatory authorities.
B2B — organisations
- Reduced compliance costs through automated documentation and simplified audit processes for research institutions and pharmaceutical companies.
Employees
- Less manual documentation work and automated compliance checks relieve study coordinators and medical staff.
Challenges
General
- Limited control over Bitcoin key pair management restricts patient autonomy in the current proof-of-concept implementation.
- The scalability of blockchain technology for large volumes of consent documents is not yet fully resolved.
B2B — organisations
- Integration into existing clinical study systems requires significant IT investment and technical expertise from research institutions.
Employees
- Medical staff must acquire new technical skills and adapt to changed digital workflows.
Technology foundation
The system is based on ChainScript, a blockchain solution from Stratumn, which builds on the Proof-of-Process concept and is specially developed for documenting business processes. This technology enables each step of consent collection to be timestamped immutably and all signatures as well as interactions to be securely stored.
Implementation examples
Proof-of-Concept protocol for consent documentation
The team wanted to eliminate the susceptibility to manipulation of traditional documentation methods for consent forms in clinical trials. At the same time, transparency and traceability of the entire consent process for regulatory authorities and audit purposes were to be improved.
The research team developed a blockchain-based protocol for the secure documentation of consent forms in clinical trials.
The team implemented a ChainScript-based solution that timestamps every step of the consent collection and immutably stores all relevant interactions such as investigator uploads, email communications, and participant signatures. The proof-of-concept implementation demonstrates the fundamental feasibility of blockchain technology for enhancing transparency and traceability in clinical trials. The system uses Stratumn's Proof-of-Process concept for structured documentation of all process steps.
The solution addresses the fundamental problem of data integrity in consent documents and eliminates the risk of subsequent manipulation. Additionally, compliance verification is significantly simplified through automatic audit trails.
Tags
Clinical trials, Consent form, Documentation, Transparency, Proof-of-Concept