  Clinical trials are a multi-billion dollar industry. One of the biggest
challenges facing the clinical trial research community is satisfying Part 11
of Title 21 of the Code of Federal Regulations and ISO 27789. These controls
provide audit requirements that guarantee the reliability of the data contained
in the electronic records. Context-aware smart devices and wearable IoT devices
have become increasingly common in clinical trials. Electronic Data Capture
(EDC) and Clinical Data Management Systems (CDMS) do not currently address the
new challenges introduced using these devices. The healthcare digital threat
landscape is continually evolving, and the prevalence of sensor fusion and
wearable devices compounds the growing attack surface. We propose Scrybe, a
permissioned blockchain, to store proof of clinical trial data provenance. We
illustrate how Scrybe addresses each control and the limitations of the
Ethereum-based blockchains. Finally, we provide a proof-of-concept integration
with REDCap to show tamper resistance.
