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One key area impacted by these challenges is eligibility assessment, which is critical in clinical trials but often limited in depth during remote screening procedures. Integrating personal health records may help address this issue. This randomized, open\u2010label, single\u2010center, fully remote study evaluated the feasibility of using personal health records for eligibility assessment in 20 healthy Korean adults. During initial screening interviews, most participants reported being healthy with no significant medical history or prior medication use. However, after reviewing their personal health records, including their past 2\u2010year health check\u2010ups and recent 3\u2010month prescription records, medical histories were revealed for 9 participants (45.0%, 17 cases), and 10 (50.0%, 68 cases) showed prior medication use. These findings suggest that personal health record\u2010based interviews could substantially improve data integrity in eligibility assessments. In addition, the study incorporated various decentralized elements, such as electronic consent acquisition, self\u2010recorded diary submission, smartwatch\u2010based AI system for drug administration monitoring, and digital reporting of adverse events and concomitant medications. While compliance was generally adequate and participants reported high satisfaction, some experienced challenges retrieving personal health records and using the smartwatch, highlighting digital accessibility as a barrier in decentralized trials. Receiving and returning research materials through the parcel and blood sampling process at local hospitals also received high ratings, but this high score reflects Korea's unique infrastructure, including extensive delivery systems and accessible local hospitals.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial Registration<\/jats:title><jats:p>KCT0009827.<\/jats:p><\/jats:sec>","DOI":"10.1111\/cts.70267","type":"journal-article","created":{"date-parts":[[2025,6,6]],"date-time":"2025-06-06T06:44:18Z","timestamp":1749192258000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Integrating Personal Health Records to Improve Data Integrity in Trials With Decentralized Elements: A Pilot Study"],"prefix":"10.1111","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-2141-2407","authenticated-orcid":false,"given":"Yoonjin","family":"Kim","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics Seoul National University College of Medicine and Hospital  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1872-9954","authenticated-orcid":false,"given":"Ki Young","family":"Huh","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics Seoul National University College of Medicine and Hospital  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0921-7225","authenticated-orcid":false,"given":"Kyung\u2010Sang","family":"Yu","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics Seoul National University College of Medicine and Hospital  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,6,5]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41746\u2010021\u201000473\u2010w"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.adq4994"},{"key":"e_1_2_9_4_1","volume-title":"Digital Health Technologies for Remote Data Acquisition in Clinical Investigations: Guidance for Industry, Investigators, and Other Stakeholders","author":"U.S. Food and Drug Administration","year":"2023"},{"key":"e_1_2_9_5_1","volume-title":"Recommendation Paper on Decentralised Elements in Clinical Trials","author":"European Medicines Agency","year":"2022"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.2196\/43086"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2628"},{"key":"e_1_2_9_8_1","unstructured":"Service KHI Personal Health Record Korea Health Information Service.2024 https:\/\/k\u2010his.or.kr\/menu.es?mid=a10204000000."},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2022.837197"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.13594"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.13617"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.13246"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.3390\/s21113594"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12275\u2010022\u20101526\u20100"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00394\u2010015\u20101045\u20104"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1080\/07315724.2018.1523028"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13063\u2010023\u201007563\u2010y"},{"key":"e_1_2_9_18_1","volume-title":"Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice: Guidance for Industry, Draft Guidance","author":"U.S. Food and Drug Administration","year":"2024"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen\u20102020\u2010040999"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.2196\/12070"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1177\/17407745231193137"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.4258\/hir.2021.27.2.102"},{"key":"e_1_2_9_23_1","unstructured":"J.Valverde\u2010Albacete F.Folkvord F.Lupi\u00e1\u00f1ez\u2010Villanueva et\u00a0al. \u201cBenchmarking Deployment of eHealth Among General Practitioners (2018): Final Report. 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