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Volumn 52, Issue 7, 2004, Pages 453-458

Forming your phase III trial's data and safety monitoring board: A perspective on safety

Author keywords

Clinical trials; Data safety monitoring boards; Safety monitoring

Indexed keywords

CLINICAL TRIAL; EVIDENCE BASED MEDICINE; PRACTICE GUIDELINE; PROFESSIONAL STANDARD; REVIEW; SAFETY; ARTICLE; CONTROLLED STUDY; HUMAN; MEDICAL RESEARCH; PHASE 3 CLINICAL TRIAL;

EID: 11244299567     PISSN: 17088267     EISSN: None     Source Type: Journal    
DOI: 10.1136/jim-52-07-37     Document Type: Review
Times cited : (9)

References (11)
  • 2
    • 0003770817 scopus 로고    scopus 로고
    • National Institutes of Health. NIH policy for data and safety monitoring - 1998. Available at: http://grants.nih.gov/grants/guide/notice-files/not98-084. html (accessed September 29, 2004).
    • NIH Policy for Data and Safety Monitoring - 1998
  • 3
    • 0037007685 scopus 로고    scopus 로고
    • Improving protection for research subjects
    • Steinbrook R. Improving protection for research subjects. N Engl J Med 2002;346:1425-30
    • (2002) N Engl J Med , vol.346 , pp. 1425-1430
    • Steinbrook, R.1
  • 4
    • 11244319596 scopus 로고
    • Bethesda, MD: National Institutes of Health
    • National Institutes of Health. Clinical trial committee guide. Vol. 8 No. 8. Bethesda, MD: National Institutes of Health; 1979.
    • (1979) Clinical Trial Committee Guide , vol.8 , Issue.8
  • 6
    • 11244338132 scopus 로고
    • March 18
    • National Institutes of Health. NIH Guide 23(11):March 18, 1994.
    • (1994) NIH Guide , vol.23 , Issue.11
  • 8
    • 0002411973 scopus 로고    scopus 로고
    • Data safety monitoring boards: A brief introduction
    • Wittes J. Data safety monitoring boards: a brief introduction. Biopharm Rep 2000;8:1-7.
    • (2000) Biopharm Rep , vol.8 , pp. 1-7
    • Wittes, J.1
  • 9
    • 0032493079 scopus 로고    scopus 로고
    • Masked monitoring in clinical trials: Blind stupidity?
    • Meinert CL. Masked monitoring in clinical trials: blind stupidity? N Engl J Med 1998;338:1381-2.
    • (1998) N Engl J Med , vol.338 , pp. 1381-1382
    • Meinert, C.L.1
  • 10


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.