{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T04:20:10Z","timestamp":1772166010681,"version":"3.50.1"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2023,4,6]],"date-time":"2023-04-06T00:00:00Z","timestamp":1680739200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,4,6]],"date-time":"2023-04-06T00:00:00Z","timestamp":1680739200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"the New Drug Creation Project of The 13th Five-Year National Science and Technology Major Special Project","award":["2020ZX09201-003"],"award-info":[{"award-number":["2020ZX09201-003"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Med Inform Decis Mak"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The process of initiating and completing clinical drug trials in hospital settings is highly complex, with numerous institutional, technical, and record-keeping barriers. In this study, we independently developed an integrated clinical trial management system (CTMS) designed to comprehensively optimize the process management of clinical trials. The CTMS includes system development methods, efficient integration with external business systems, terminology, and standardization protocols, as well as data security and privacy protection.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The development process proceeded through four stages, including demand analysis and problem collection, system design, system development and testing, system trial operation, and training the whole hospital to operate the system. The integrated CTMS comprises three modules: project approval and review management, clinical trial operations management, and background management modules. These are divided into seven subsystems and 59 internal processes, realizing all the functions necessary to comprehensively perform the process management of clinical trials. Efficient data integration is realized through extract-transform-load, message queue, and remote procedure call services with external systems such as the hospital information system (HIS), laboratory information system (LIS), electronic medical record (EMR), and clinical data repository (CDR). Data security is ensured by adopting corresponding policies for data storage and data access. Privacy protection complies with laws and regulations and de-identifies sensitive patient information.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The integrated CTMS was successfully developed in September 2015 and updated to version 4.2.5 in March 2021. During this period, 1388 study projects were accepted, 43,051 electronic data stored, and 12,144 subjects recruited in the First Affiliated Hospital, Zhejiang University School of Medicine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The developed integrated CTMS realizes the data management of the entire clinical trials process, providing basic conditions for the efficient, high-quality, and standardized operation of clinical trials.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s12911-023-02158-8","type":"journal-article","created":{"date-parts":[[2023,4,6]],"date-time":"2023-04-06T10:02:53Z","timestamp":1680775373000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Development of an integrated and comprehensive clinical trial process management system"],"prefix":"10.1186","volume":"23","author":[{"given":"Liang","family":"Shen","sequence":"first","affiliation":[]},{"given":"You","family":"Zhai","sequence":"additional","affiliation":[]},{"given":"AXiang","family":"Pan","sequence":"additional","affiliation":[]},{"given":"Qingwei","family":"Zhao","sequence":"additional","affiliation":[]},{"given":"Min","family":"Zhou","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6882-0468","authenticated-orcid":false,"given":"Jian","family":"Liu","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2023,4,6]]},"reference":[{"key":"2158_CR1","doi-asserted-by":"publisher","first-page":"899","DOI":"10.1124\/pr.120.000028","volume":"72","author":"MD Kruizinga","year":"2020","unstructured":"Kruizinga MD, Stuurman FE, Exadaktylos V, Doll RJ, Stephenson DT, Groeneveld GJ, et al. Development of novel, value-based, digital endpoints for clinical trials: a structured approach Toward fit-for-purpose validation. Pharmacol Rev. 2020;72:899\u2013909.","journal-title":"Pharmacol Rev"},{"key":"2158_CR2","doi-asserted-by":"publisher","first-page":"821","DOI":"10.1038\/d41573-020-00146-5","volume":"19","author":"R Davi","year":"2020","unstructured":"Davi R, Mahendraratnam N, Chatterjee A, Dawson CJ, Sherman R. Informing single-arm clinical trials with external controls. Nat Rev Drug Discov. 2020;19:821\u20132.","journal-title":"Nat Rev Drug Discov"},{"key":"2158_CR3","doi-asserted-by":"publisher","first-page":"320","DOI":"10.1038\/s41571-021-00503-2","volume":"18","author":"A Desai","year":"2021","unstructured":"Desai A, Gainor JF, Hegde A, Schram AM, Curigliano G, Pal S, et al. Author Correction: COVID-19 vaccine guidance for patients with cancer participating in oncology clinical trials. 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Lancet Neurol. 2021;20:10\u20132.","journal-title":"Lancet Neurol"},{"key":"2158_CR6","doi-asserted-by":"publisher","first-page":"28","DOI":"10.2174\/1574887114666191016103332","volume":"15","author":"S Bhagat","year":"2020","unstructured":"Bhagat S, Kapatkar VK, Mane A, Pinto C, Parikh D, Mittal G, et al. An industry perspective on risks and mitigation strategies associated with post conduct phase of clinical trial. Rev Recent Clin Trials. 2020;15:28\u201333.","journal-title":"Rev Recent Clin Trials"},{"issue":"1","key":"2158_CR7","doi-asserted-by":"publisher","first-page":"10","DOI":"10.2174\/1574887113666180924165230","volume":"14","author":"A Nourani","year":"2019","unstructured":"Nourani A, Ayatollahi H, Dodaran MS. A review of clinical data management systems used in clinical trials. 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All executive trials included in this study system were the\nClinical Trial Ethics Committee (EC) of The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU) reviewed\nand approved. All subjects in these trials signed informed consents prior to\nenrollment.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"61"}}