{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T21:11:31Z","timestamp":1785273091413,"version":"3.55.0"},"reference-count":21,"publisher":"XMLink","issue":"36","license":[{"start":{"date-parts":[[2020,1,1]],"date-time":"2020-01-01T00:00:00Z","timestamp":1577836800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["jkms.org"],"crossmark-restriction":false},"short-container-title":["J Korean Med Sci"],"DOI":"10.3346\/jkms.2020.35.e329","type":"journal-article","created":{"date-parts":[[2020,9,8]],"date-time":"2020-09-08T00:06:09Z","timestamp":1599523569000},"update-policy":"https:\/\/doi.org\/10.3346\/crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["The Impact of COVID-19 on the Conduct of Clinical Trials for Medical Products in Korea"],"prefix":"10.3346","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8365-5808","authenticated-orcid":false,"given":"JuYeun","family":"Jeon","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea."},{"name":"Department of Project Leadership, IQVIA, Seoul, Korea."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8423-8512","authenticated-orcid":false,"given":"Hyeikyoung","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Project Leadership, IQVIA, Seoul, Korea."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0921-7225","authenticated-orcid":false,"given":"Kyung-Sang","family":"Yu","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"18617","published-online":{"date-parts":[[2020]]},"reference":[{"key":"10.3346\/jkms.2020.35.e329_ref1","unstructured":"Korea Clinical Trials Information Center. Updated 2020. Accessed June 29, 2020.  https:\/\/www.koreaclinicaltrials.org\/kr\/contents\/datainfo_data_01_tab03\/view.do"},{"key":"10.3346\/jkms.2020.35.e329_ref2","unstructured":"Ministry of Food and Drug Safety. Presentation of the results of approval of clinical trials for medicines in Korea in 2018. Updated 2019. Accessed May 4, 2020.  https:\/\/www.mfds.go.kr\/brd\/m_99\/view.do?seq=43284"},{"key":"10.3346\/jkms.2020.35.e329_ref3","unstructured":"ICH GCP. ICH harmonized guideline integrated addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2) ICH Consensus Guideline. Updated 2017. Accessed June 29, 2020.  https:\/\/ichgcp.net\/"},{"issue":"10","key":"10.3346\/jkms.2020.35.e329_ref4","doi-asserted-by":"crossref","first-page":"e112","DOI":"10.3346\/jkms.2020.35.e112","volume":"35","author":"Korean Society of Infectious Diseases","year":"2020","journal-title":"J Korean Med Sci"},{"key":"10.3346\/jkms.2020.35.e329_ref5","unstructured":"Ministry of Health. Daily status of Middle East Respiratory Syndrome, MERS. Updated 2018. Accessed June 29, 2020.  http:\/\/www.mohw.go.kr\/react\/al\/sal0301ls.jsp?PAR_MENU_ID=04&MENU_ID=0403"},{"key":"10.3346\/jkms.2020.35.e329_ref6","unstructured":"Korea Centers for Disease Control and Prevention. COVID-19 response guideline 9th edition by Central Disaster Management Headquarters \u00b7 Central Disease Control Headquarters. Updated 2020. Accessed June 29, 2020.  https:\/\/www.cdc.go.kr\/board\/board.es?mid=a20507020000&bid=0019"},{"key":"10.3346\/jkms.2020.35.e329_ref7","unstructured":"Korea Pharmaceutical and Bio-Pharma Manufacturers' Association. 2019 Pharmaceutical Industry Database Book Statistical Information. Updated 2019. Accessed June 29, 2020.  http:\/\/www.kpbma.or.kr"},{"key":"10.3346\/jkms.2020.35.e329_ref8","unstructured":"Ministry of Food and Drug Safety. Integrated drug information system. Updated 2020. Accessed June 24, 2020.  https:\/\/nedrug.mfds.go.kr\/searchClinic"},{"key":"10.3346\/jkms.2020.35.e329_ref9","unstructured":"U.S National Library of Medicine. ClinicalTrials.gov. Updated 2020. Accessed June 28, 2020.  https:\/\/clinicaltrials.gov\/"},{"key":"10.3346\/jkms.2020.35.e329_ref10","unstructured":"Ministry Health and Welfare. Daily status of COVID-19. Updated 2020. Accessed March 20, 2020.  http:\/\/ncov.mohw.go.kr\/bdBoardList_Real.do"},{"key":"10.3346\/jkms.2020.35.e329_ref11","unstructured":"Korean Hospital Association. Updated 2020. Accessed June 28, 2020.  https:\/\/www.kha.or.kr"},{"key":"10.3346\/jkms.2020.35.e329_ref12","unstructured":"Ministry of Food and Drug Safety. Considerations for clinical trials in a situation of COVID-19. Updated 2020. Accessed March 27, 2020.  https:\/\/www.mfds.go.kr\/index.do"},{"key":"10.3346\/jkms.2020.35.e329_ref13","unstructured":"Ministry of Food and Drug Safety. Notice of training considerations for clinical trial workers according to corona 19 situation. Updated 2020. Accessed June 28, 2020.  https:\/\/www.mfds.go.kr\/index.do"},{"key":"10.3346\/jkms.2020.35.e329_ref14","unstructured":"United Kingdom Medicines and Healthcare Products Regulatory Agency. Synopsis of MHRA advice on management of clinical trials in relation to coronavirus. Updated 2020. Accessed March 27, 2020.  https:\/\/www.gov.uk\/government\/collections\/mhra-guidance-on-coronavirus-covid-19"},{"key":"10.3346\/jkms.2020.35.e329_ref15","unstructured":"Korea National Enterprise for Clinical Trials. Analysis of domestic and international clinical trials. Updated 2020. Accessed June 28, 2020.  https:\/\/www.koreaclinicaltrials.org\/kr\/board\/covid19_smry\/boardView.do?bbsIdx=888&pageIndex=1&searchCondition=&searchKeyword="},{"key":"10.3346\/jkms.2020.35.e329_ref16","unstructured":"Korea National Enterprise for Clinical Trials. KoNECT brief. Ed1. Updated 2020. Accessed March 27, 2020.  https:\/\/www.konect.or.kr\/"},{"key":"10.3346\/jkms.2020.35.e329_ref17","unstructured":"Food and Drug Administration. Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. Updated 2020. Accessed June 28, 2020.  https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency"},{"key":"10.3346\/jkms.2020.35.e329_ref18","unstructured":"European Medicines Agency. Guidance on the management of clinical trials during the COVID-19 Pandemic. Updated 2020. Accessed June 28, 2020.  https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-10\/guidanceclinicaltrials_covid19_en.pdf"},{"key":"10.3346\/jkms.2020.35.e329_ref19","unstructured":"Korea Ministry of Government Legislation. Korea Pharmaceutical Affairs Act. Updated 2020. Accessed June 28, 2020.  http:\/\/law.go.kr\/%EB%B2%95%EB%A0%B9\/%EC%95%BD%EC%82%AC%EB%B2%95\/%EC%A0%9C50%EC%A1%B0"},{"key":"10.3346\/jkms.2020.35.e329_ref20","unstructured":"Association of Clinical Research Organizations. ACRO's considerations on monitoring during COVID-19. Updated 2020. Accessed June 28, 2020.  https:\/\/www.acrohealth.org\/acro-considerations-on-monitoring-during-covid-19\/"},{"key":"10.3346\/jkms.2020.35.e329_ref21","unstructured":"The Italian Medicines Agency (AIFA). Clinical trials' management in Italy during the COVID-19 (coronavirus disease 19) emergency. Updated 2020. Accessed June 28, 2020.  https:\/\/www.aifa.gov.it\/documents\/20142\/871583\/Comunicato_gestione_studi_clinici_in_emergenza_COVID-19_EN_12.03.2020.pdf\/ee1f33e3-bb3e-9ce9-2a93-b33e88eea94d"}],"container-title":["Journal of Korean Medical Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jkms.org\/pdf\/10.3346\/jkms.2020.35.e329","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/jkms.org\/DOIx.php?id=10.3346\/jkms.2020.35.e329","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/jkms.org\/DOIx.php?id=10.3346\/jkms.2020.35.e329","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,9,8]],"date-time":"2020-09-08T00:07:11Z","timestamp":1599523631000},"score":1,"resource":{"primary":{"URL":"https:\/\/jkms.org\/DOIx.php?id=10.3346\/jkms.2020.35.e329"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020]]},"references-count":21,"journal-issue":{"issue":"36","published-online":{"date-parts":[[2020]]}},"URL":"https:\/\/doi.org\/10.3346\/jkms.2020.35.e329","relation":{},"ISSN":["1011-8934","1598-6357"],"issn-type":[{"value":"1011-8934","type":"print"},{"value":"1598-6357","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020]]},"assertion":[{"value":"2020-07-21","name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-08-26","name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-09-07","name":"published_online","label":"Published online","group":{"name":"publication_history","label":"Publication History"}},{"value":"\u00a9 2020 The Korean Academy of Medical Sciences.","name":"copyright","label":"Copyright","group":{"name":"Copyright_and_licensing","label":"Copyright and Licensing"}},{"value":"This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.","name":"license","label":"License","explanation":{"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},"group":{"name":"Copyright_and_licensing","label":"Copyright and Licensing"}}],"article-number":"e329"}}