Clinical Research Support
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Clinical Research Support Program
National Clinical Research Coordination Task Force(NCRC)
Clinical research is research on patients, with various scopes of study on the prevention, early detection, and diagnosis of diseases, as well as medical treatment. Clinical research advances health and medical care technology, and provides clinical trial-based evidence to help physicians make decisions about healthcare services. Given the emphasis that health care services should be offered based on evidence, the standards for international clinical research have been instituted and developed on an ongoing basis. To cope with this challenge, the need for efficient data management and transparency during clinical research has increased. In 2008, to respond to this need, the National Clinical Research Coordination Task Force (NCRCTF) was established at the Korea National Institute of Health (KNIH), and the TF has been operating the Clinical Research Support Program. This program is designed to share information of clinical research to be conducted in Korea and to support the domestic research centers in conducting further clinical research by providing management systems and training programs.
The objectives of the Clinical Research Support Program are: (1) to secure transparency and ethics in clinical research; (2) to improve the quality of clinical research by providing a management system and training program for researchers; and (3) to develop medical care service based on evidence by revitalizing clinical research. For these objectives, the TF includes three main activities: (1) operating the Clinical Research Information Service (CRIS), (2) providing the Clinical Research and Trial Management System (iCReaT), and (3) offering a Clinical Research Education Program.
Clinical Research Information Service(CRIS)
The Clinical Research Information Service (CRIS, https://cris.nih.go.kr) is a nonprofit online registration system for clinical research, and it became the 11th Primary Registry of the WHO International Clinical Trials Registry Platform (ICTRP) in May 2010. The main purposes of the CRIS are: (1) to improve transparency, accountability, and ethicality of clinical research to be conducted in Korea; and (2) to establish medical research infrastructure based on scientific evidence. Since May 2010, we have consistently endeavored to institutionalize the registration of clinical research, and to make researchers more aware of the importance of registration of clinical research through various activities such as (1) amending “The Regulation for Management of Health and Medical Technology R&D Projects” (effective as of Feb 13, 2012), which specifies that the registration of clinical research designated by the Minister of Health and Welfare is mandatory; (2) sending the IRBs the information letter with the CRIS pamphlet; (3) introducing CRIS to the researchers at the relevant forum; and (4) publishing a report in the KNIH newsletter and magazine. In addition, we started the CRIS mobile service in April 2013. Through these activities, the rate of clinical registration into the CRIS has continuously increased, and 3,671 studies were registered in the CRIS as of March 31, 2019. The information entered into the CRIS is transferred to WHO ICTRP once a month and then it is made available to the public worldwide.