title: Review of the Registration in the Clinical Research Information Service.
abstract: Clinical research registration is required in many countries to improve transparency of clinical research and to ensure subject safety. Developed in February 2010, the Clinical Research Information Service (CRIS) is an online registration system for clinical studies in Korea and one of the primary registries of the World Health Organization (WHO) International Clinical Trials Registry Platform. The present analysis investigated the characteristics of studies registered in the CRIS between February 2010 and December 2014. Data for the analysis were extracted from the CRIS database. As of December 31, 2014, 1,323 clinical studies were registered. Of these, 938 (70.9%) were interventional studies and 385 (29.1%) were observational studies. A total of 248 (18.7%) studies were funded by government sources, 1,051 (79.4%) by non-government sources, and 24 (1.8%) by both. The most frequently studied disease category based on the ICD-10 classification was the digestive system (13.1%), followed by the nervous system (9.4%) and musculoskeletal system (9.1%). Only 17.8% of the studies were registered prior to enrollment of the first subject. Comparing the number of registered or approved clinical studies between the CRIS, the Ministry of Food and Drug Safety, and ClinicalTrials.gov suggests that a considerable number of clinical studies are not registered with the CRIS; therefore, we would suggest that such registration should be the mandatory legal requirement.
authors.affiliation: Division of Cardiovascular and Rare Disease, Center for Biomedical Science, Korea National Institute of Health, Cheongju, Korea.
authors.forename: Eun-Kyoung
authors.identifier: 0000-0003-2047-2497
authors.initials: EK
authors.lastname: Choi
authors.affiliation: Division of Cardiovascular and Rare Disease, Center for Biomedical Science, Korea National Institute of Health, Cheongju, Korea.
authors.forename: Mi-Jung
authors.identifier: 0000-0001-5903-2320
authors.initials: MJ
authors.lastname: Kim
authors.affiliation: Division of Cardiovascular and Rare Disease, Center for Biomedical Science, Korea National Institute of Health, Cheongju, Korea.
authors.forename: Nam-Kyoo
authors.identifier: 0000-0002-3354-7040
authors.initials: NK
authors.lastname: Lim
authors.affiliation: Division of Cardiovascular and Rare Disease, Center for Biomedical Science, Korea National Institute of Health, Cheongju, Korea.
authors.forename: Hyun-Young
authors.identifier: 0000-0002-6698-7368
authors.initials: HY
authors.lastname: Park
mesh_terms: D035843:Biomedical Research; D002986:Clinical Trials as Topic; D016208:Databases, Factual; D006801:Humans; D007255:Information Services; D020407:Internet; D012042:Registries; D056910:Republic of Korea
keywords: Clinical Trials as Topic; Databases, Factual; Information Dissemination; Internet; Registries; Republic of Korea