Event Abstract Back to Event Presenting a decentralized, centrally governed, secure open source software solution for over-volunteering leveraging blockchain and biometrics Stuart D. Robertson1* and Brock Heinz2* 1 Foundry Health, Engineering, United States 2 Foundry Health, Engineering, United States Purpose: There are currently a variety of centralized services attempting to address over-volunteering, particularly in Europe i. But there is no clear international and open solution, and some authors show evidence that certain regions are currently well served. ii We believe this key safety and quality concern can be effectively addressed by a modern subject volunteering registry leveraging Blockchain and biometric subject identification and verification. Method: To demonstrate this, we will present and release, as open source software, a prototype implementation supporting the following characteristics: • Fully decentralized execution: many readers and writers. eSource vendors, CROs, pharma, government agencies, etc. can all integrate directly with the implementation, and WebServices expose it for potentially less technical consumers. • Protection of confidential and private information is of the highest concern. No individual-identifiable information is stored in the Blockchain. Only the minimum amount of subject trial activity is stored, such as time of last screening, time last trial dose received, etc. Even so, all data is decryptable only by authorized entities. • Multi-factor individual identification and verification, including a simple hash of data from verifiable documents (initials, DOB, national identifier suffix, etc.) in addition to one or more biometric means. Conclusion: Our hope is that making this software available free of charge will further increase the safety and reduce risk in clinical trials conducted in Europe, and meet the expectation of the regulators.