국내 임상시험에 관한 정보 검색의 현황과 개선방안

• 영문명: The Current Status and the Improvement Plan of Information Retrieval on Clinical Trials in Korea
• 발행기관: 이화여자대학교 생명의료법연구소
• 저자명: 나은영(NA, Eun Young)
• 간행물 정보: 『생명윤리정책연구(제 9권 제 3호 이전)』제2권 제2호, 177~192쪽, 전체 16쪽
• 주제분류: 법학 > 법학
• 파일형태: PDF
• 발행일자: 2008.08.30

영문 초록

This year, the number of approved clinical trials in Korea is expected to exceed approximately 300 cases. In regards to this, the Korea Food & Drug Administration provides statistical data and related laws and guidelines on clinical trials through the Release of clinical trials information from its website. However, it is not easy to instantly search the basic information related to the study of design, process, subject s consent form, recruitment of subject, and sponsor s contacts information, etc. Accordingly, the ClinicalTrials.gov that is administered by the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) will be compared against the Release of clinical trial information of the Korea Food & Drug Administration in order to identify the proper ways to manage and disclose the clinical trial information to the public.

목차

Ⅰ. 서론

Ⅱ. ‘임상정보방’의 운영 현황 및 문제점

Ⅲ. 미국의 임상시험 정보 관리

Ⅳ. ‘임상정보방’의 효율적 운영을 위한 제언

Ⅴ. 결론

키워드

임상시험(Clinical trials) 정보검색(Information retrieval) 임상정보방(Release of clinical trials information) 미국 임상시험정보(Clinicaltrials.gov)