메뉴 건너뛰기




Volumn 24, Issue 1, 2002, Pages 59-66

Regulatory issues for clinical trials in humans

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

EID: 0036019116     PISSN: 0193936X     EISSN: None     Source Type: Journal    
DOI: 10.1093/epirev/24.1.59     Document Type: Review
Times cited : (5)

References (28)
  • 1
    • 0009721588 scopus 로고    scopus 로고
    • Rockville, MD: Food and Drug Administration, US Department of Health and Human Services
    • (1999) Title 21 - Food and drugs
  • 3
    • 0026427330 scopus 로고
    • Protection of human subjects; informed consent; standards for institutional review boards for clinical investigations - FDA. Final rule
    • 45 CFR §46
    • (1991) Fed Regist , vol.56 , pp. 28025-28029
  • 5
    • 0032489187 scopus 로고    scopus 로고
    • Treatment of research-related injuries to human subjects - VA. Final rule
    • 38 CFR §17.85
    • (1998) Fed Regist , vol.63 , pp. 11123-11124
  • 17
    • 79551708303 scopus 로고    scopus 로고
    • Notice of suspension of PHS policy on instruction in the responsible conduct of research
    • (2001) Fed Regist , vol.6 , pp. 11032-11033
  • 27
    • 0001184885 scopus 로고    scopus 로고
    • Guideline for good clinical practice
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
    • (1997) Fed Regist , vol.62 , pp. 25691-25709
  • 28
    • 0009721591 scopus 로고    scopus 로고
    • New privacy rules could impact sites' chart review research
    • (2001) Clin Trials Advisor , vol.6 , pp. 1-4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.