{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T17:50:00Z","timestamp":1792173000532,"version":"4.4.0"},"reference-count":13,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T00:00:00Z","timestamp":1791244800000},"content-version":"vor","delay-in-days":5,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100006108","name":"National Center for Advancing Translational Sciences","doi-asserted-by":"publisher","award":["UM1TR004403"],"award-info":[{"award-number":["UM1TR004403"]}],"id":[{"id":"10.13039\/100006108","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Protocol deviations threaten data integrity, regulatory compliance, and participant safety in clinical trials. Despite their prevalence, few longitudinal studies have characterized deviation patterns and described quality improvement strategies within clinical research units (CRUs). This descriptive longitudinal quality improvement study analyzed protocol deviations and prevented incidents reported at the University of Iowa CRU from June 17, 2020, through December 31, 2024. Events were captured via online survey and classified using a five\u2010grade severity scale. Pearson's chi\u2010square tests assessed associations between event characteristics and outcomes. During the survey data\u2010collection period, 11,581 CRU visits were recorded. Overall, 261 events were reported, including 100 incidents prevented before becoming protocol deviations and 68 confirmed protocol deviations; 93 events preceded systematic collection of the prevented\/resulted classification. Grade 1 was the most frequently selected severity classification (126 of 178 severity\u2010grade selections; 70.8%). The laboratory (60.2%) and study setup (33.7%) were the most frequent event contexts. Among events with a prevented\/resulted classification, Grade 1 events were more frequently prevented than Grade 2\u20135 events (71.8% vs. 25.0%;\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.0001). Quality improvement strategies implemented during the observation period included dedicated study liaisons, standardized start\u2010up checklists, increased staffing, and structured communication processes. Lower\u2010severity events were more frequently prevented before resulting in protocol deviations. These findings identify operational contexts and event characteristics that may inform proactive, systems\u2010based approaches to deviation prevention in CRUs.\n                  <\/jats:p>","DOI":"10.1111\/cts.70739","type":"journal-article","created":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T04:28:16Z","timestamp":1791347296000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Protocol Deviations at an Academic Clinical Research Unit: Insights and Strategies for Prevention"],"prefix":"10.1111","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1482-8226","authenticated-orcid":false,"given":"Maran","family":"Subramain","sequence":"first","affiliation":[{"name":"Institute for Clinical and Translational Science University of Iowa  Iowa City Iowa USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5041-0708","authenticated-orcid":false,"given":"Patrick","family":"Ten Eyck","sequence":"additional","affiliation":[{"name":"Institute for Clinical and Translational Science University of Iowa  Iowa City Iowa USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristy","family":"Mahan","sequence":"additional","affiliation":[{"name":"Institute for Clinical and Translational Science University of Iowa  Iowa City Iowa USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jackline","family":"Wangui","sequence":"additional","affiliation":[{"name":"Institute for Clinical and Translational Science University of Iowa  Iowa City Iowa USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimberly","family":"Sprenger","sequence":"additional","affiliation":[{"name":"Institute for Clinical and Translational Science University of Iowa  Iowa City Iowa USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Sr.","given":"Donald G.","family":"McCloud","sequence":"additional","affiliation":[{"name":"Western Michigan University  Kalamazoo Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8499-3721","authenticated-orcid":false,"given":"John M.","family":"Buatti","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology University of Iowa  Iowa City Iowa USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1521-7520","authenticated-orcid":false,"given":"Alejandro P.","family":"Comellas","sequence":"additional","affiliation":[{"name":"Institute for Clinical and Translational Science University of Iowa  Iowa City Iowa USA"},{"name":"Department of Internal Medicine University of Iowa  Iowa City Iowa USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,10,6]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.mayocp.2023.04.013"},{"key":"e_1_2_11_3_1","unstructured":"U.S. Food and Drug Administration \u201cProtocol Deviations for Clinical Investigations of Drugs Biological Products and Devices: Draft Guidance for Industry \u201d(2024) https:\/\/www.fda.gov\/media\/184745\/download."},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.4103\/2229\u20103485.184817"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s43441\u2010021\u201000269\u2010w"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1186\/1745\u20106215\u201012\u2010214"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s43441\u2010022\u201000401\u20104"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s43441\u2010023\u201000604\u20103"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s43441\u2010025\u201000828\u20105"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1017\/cts.2023.514"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1017\/cts.2024.454"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(02)07373\u20107"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.4103\/picr.picr_69_23"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.60787\/nmj\u2010v65i3\u2010421"}],"container-title":["Clinical 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