메뉴 건너뛰기




Volumn 20, Issue 17-18, 2001, Pages 2573-2583

Independent data monitoring committees: Rationale, operations and controversies

Author keywords

[No Author keywords available]

Indexed keywords

ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; ANTIINFECTIVE AGENT; ANTIVIRUS AGENT; NEW DRUG;

EID: 0035884169     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/sim.730     Document Type: Article
Times cited : (24)

References (39)
  • 2
    • 0023874973 scopus 로고
    • Organization, review and administration of cooperative studies (Greenberg Report): A report from the Heart Special Project Committee to the National Advisory Heart Council, May 1967
    • (1988) Controlled Clinical Trials , vol.9 , pp. 137-148
  • 19
    • 0003603567 scopus 로고    scopus 로고
    • Policy of the National Cancer Institute for Data and Safety Monitoring of Clinical Trials. Available at
  • 20
    • 0027417271 scopus 로고
    • Data monitoring committees and capturing relevant information of high quality
    • Discussion: Tom Fleming.
    • (1993) Statistics in Medicine , vol.12 , pp. 571-573
  • 29
    • 0003634479 scopus 로고    scopus 로고
    • Code of Federal Regulations. 21 Part 50.24 revised as of April 1, 1999 U.S. Government Printing Office: Washington, D.C.
    • (1999)
  • 31
    • 0033566769 scopus 로고    scopus 로고
    • ICH Harmonised tripartite guideline: Statistical principles for clinical trials. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use
    • ICH.
    • (1999) Statistics in Medicine , vol.18 , pp. 1905-1942
  • 32
    • 0001184885 scopus 로고    scopus 로고
    • Guideline for Industry: Good Clinical Practice
    • U.S. Food and Drug Administration.
    • (1997) Federal Register , vol.62 , pp. 25691-25709
  • 33
    • 0003712368 scopus 로고    scopus 로고
    • Guideline for Industry: Structure and Content of Clinical Study Reports
    • U.S. Food and Drug Administration.
    • (1996) Federal Register , vol.61 , pp. 37320
  • 37
    • 0003545424 scopus 로고    scopus 로고
    • NIH Policy for Data and Safety Monitoring. NIH Guide, 12 June (available at
    • (1998)
  • 38
    • 0003603569 scopus 로고    scopus 로고
    • Cooperative Studies Program Guidelines for the Planning and Conduct of Cooperative Studies. Office of Research and Development, Department of Veterans Affairs, March
    • (1998)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.