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One of the biggest challenges facing the clinical trial research community is satisfying Part 11 of Title 21 of the Code of Federal Regulations [\n            <jats:xref ref-type=\"bibr\">7<\/jats:xref>\n            ] and ISO 27789 [\n            <jats:xref ref-type=\"bibr\">40<\/jats:xref>\n            ]. 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.\n          <\/jats:p>","DOI":"10.1145\/3491258","type":"journal-article","created":{"date-parts":[[2021,10,29]],"date-time":"2021-10-29T16:36:22Z","timestamp":1635525382000},"page":"1-20","update-policy":"https:\/\/doi.org\/10.1145\/crossmark-policy","source":"Crossref","is-referenced-by-count":7,"title":["Scrybe: A Secure Audit Trail for Clinical Trial Data Fusion"],"prefix":"10.1145","volume":"4","author":[{"given":"Jonathan","family":"Oakley","sequence":"first","affiliation":[{"name":"Clemson University, USA"}]},{"given":"Carl","family":"Worley","sequence":"additional","affiliation":[{"name":"Clemson University, USA"}]},{"given":"Lu","family":"Yu","sequence":"additional","affiliation":[{"name":"Clemson University, USA"}]},{"given":"Richard R.","family":"Brooks","sequence":"additional","affiliation":[{"name":"Clemson University, USA"}]},{"given":"\u0130lker","family":"\u00d6z\u00e7elik","sequence":"additional","affiliation":[{"name":"University of Tennessee at Chattanooga, USA"}]},{"given":"Anthony","family":"Skjellum","sequence":"additional","affiliation":[{"name":"University of Tennessee at Chattanooga, USA"}]},{"given":"Jihad S.","family":"Obeid","sequence":"additional","affiliation":[{"name":"Medical University of South Carolina, USA"}]}],"member":"320","published-online":{"date-parts":[[2022,3,10]]},"reference":[{"key":"e_1_3_2_2_2","unstructured":"Hyperledger Foundation. 2017. 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