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KMID : 0391020040120020147
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Journal of Korean Society for Clinical Pharmacology and Therapeutics
2004 Volume.12 No. 2 p.147 ~ p.162
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Developing the Infrastructure for Clinical Trial in Korea
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Kang Hyun-Sook
Jeong Ihn-Sook
Choung Se-Young
Shin Sang-Goo
Kim Won-Ock
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Abstract
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Purpose : This study was aimed to evaluate the current status and to establish the infrastructure for clinical trial in the aspects of manpower, facilities, IRB, SOP in Korea.
Method :This was used survey, literature review, visiting to developed country, discussions with the professionals in seminars and workshop.
Result : The number of professional member was less than that of the developed countries, and there’s no systematic educational programs. Second, there’s little space only for clinical trial as well as national standards is unsatisfactory. Third, the scope of IRBs review were limited, and the educational programs of IRB members and investigators were inappropriate. Fourth, the investigators site SOPs were not standardized, and the adherences to SOPs were questionable.
Conclusion : For manpower, educational programs and revision of KGCP is needed. For facilities, the standard for the clinical trial facilities should be made and be used as accreditation index of institution. For IRBs, both the scope of IRB review and training programs for IRB members should be expanded, and the quality control system of them should also be introduced. For investigator site SOP, it should be inserted into the KGCP, and SOP training programs should be developed.
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KEYWORD
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Infrastructure, Clinical trial
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