Our project seeks to demonstrate the value of blockchain technology in the Informed Consent process by creating an end-to-end audit trail in a secure and consistent manner, underpinning a higher level of trust between stakeholders participating in a clinical trial.

Why is this important?

Our proof-of-concept for a clinical trial Informed Consent ‘service backbone’ based on blockchain technology includes the delivery of system requirements so that others could adopt or build on the conceptual solution based on their own approach, and learnings for all partners involved.


The solution (BlockSent 2.0) is based on BlockSent 1.0 (a pilot developed by Novartis which manages Informed Consent template versioning, implements DID technology and Verifiable Credentials management, and anchors transactions on a blockchain layer).

What will the project achieve?

The project will:
  • Provide patients with the simplest possible system to participate in a clinical trial from any sponsor and site
  • Create an immutable audit trail for the IC process which is tamper-proof
  • Integrate with existing EDC systems used for clinical trial management
  • Conceptualize the return on investment based on BlockSent 2.0
  • Provide plans for integration with other use cases/solutions
  • Deliver a publication highlighting the BlockSent 2.0 architecture, process, and learnings

If you would like to get involved or have further questions or feedback email the project manager, Richard Norman.

Project Funders