# Blockchain-based Documentation for Clinical Trials

> 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.

**Sector:** Tertiary sector · **Industry:** Research institutes · **Organisation:** Benchoufi, Porcher & Ravaud (Forschungsteam) · **Maturity level:** Concept

Canonical URL: https://www.sapientblock.com/en/use-cases/benchoufi-studiendaten-manipulationssicher-protokollieren

## 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.

## Benefits

- Reduced compliance costs through automated documentation and simplified audit processes for research institutions and pharmaceutical companies.
- 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.
- Less manual documentation work and automated compliance checks relieve study coordinators and medical staff.

## Challenges

- Integration into existing clinical study systems requires significant IT investment and technical expertise from research institutions.
- 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.
- 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.

## Sources

- [Improving the transparency of clinical trials by blockchain-based time-stamped consent](https://f1000research.com/articles/6-66)
- [Blockchain for improving the transparency of clinical trials](https://www.frontiersin.org/journals/blockchain/articles/10.3389/fbloc.2019.00023/full)
- [Blockchain and clinical trials: hype or hope?](https://pubmed.ncbi.nlm.nih.gov/28724395/)