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Volumn 8, Issue 6, 2011, Pages 727-735

Data and safety monitoring policy for National Institute of Allergy and Infectious Diseases clinical trials

Author keywords

[No Author keywords available]

Indexed keywords

ACCESS TO INFORMATION; ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL (TOPIC); DATA AND SAFETY MONITORING; HUMAN; MANAGEMENT; MONITORING; MOTIVATION; NATIONAL HEALTH ORGANIZATION; ORGANIZATIONAL STRUCTURE; PATIENT SAFETY; POLICY; PRACTICE GUIDELINE; PRIORITY JOURNAL; PUBLIC HEALTH SERVICE; RESPONSIBILITY;

EID: 83455169023     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774511425181     Document Type: Article
Times cited : (7)

References (22)
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    • National Institute of Allergy and Infectious Diseases Version 3.0; release date 18 June 2009; effective date 2 July 2009. Available at and http://www. niaid.nih. gov/LabsAndResources /resources/toolkit/Documents/ dsmbpolicyv3.pdf
    • National Institute of Allergy and Infectious Diseases. Policy on Data and Safety Monitoring Board (DSMB) Operations. Version 3.0; release date 18 June 2009; effective date 2 July 2009. Available at http://www.niaid.nih.gov/ labsandresources/resources/toolkit/guidance/Pages/guidance.aspx and http://www.niaid.nih.gov/LabsAndResources/resources/toolkit/Documents/ dsmbpolicyv3.pdf.
    • Policy on Data and Safety Monitoring Board (DSMB) Operations
  • 2
  • 6
    • 20244368495 scopus 로고    scopus 로고
    • Issues in data monitoring and interim analysis of trials
    • Grant AM, Altman DG, Babiker AB, et al. Issues in data monitoring and interim analysis of trials. Health Technol Assess. 2005 ; 9 (7). 1-238
    • (2005) Health Technol Assess , vol.9 , Issue.7 , pp. 1-238
    • Grant, A.M.1    Altman, D.G.2    Babiker, A.B.3
  • 7
    • 4544333778 scopus 로고    scopus 로고
    • Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials
    • Sydes MR, Spiegelhalter DJ, Altman DG, et al. Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials. Clin Trials. 2004 ; 1 (1). 60-79
    • (2004) Clin Trials , vol.1 , Issue.1 , pp. 60-79
    • Sydes, M.R.1    Spiegelhalter, D.J.2    Altman, D.G.3
  • 8
    • 4544274355 scopus 로고    scopus 로고
    • Reported use of data monitoring committees in the main published reports of randomized controlled trials: A cross-sectional study
    • Sydes MR, Altman DG, Babiker AB, et al. Reported use of data monitoring committees in the main published reports of randomized controlled trials: a cross-sectional study. Clin Trials. 2004 ; 1 (1). 48-59
    • (2004) Clin Trials , vol.1 , Issue.1 , pp. 48-59
    • Sydes, M.R.1    Altman, D.G.2    Babiker, A.B.3
  • 11
    • 84855461648 scopus 로고    scopus 로고
    • US National Institutes of Health OD-00-038, June 5, 2000. Available at and http://grants.nih.gov/ grants/policy/hs/ data-safety.htm (accessed 28 March 2011)
    • US National Institutes of Health. Further Guidance on Data and Safety Monitoring for Phase I and II Trials, OD-00-038, June 5, 2000. Available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html and http://grants.nih.gov/grants/policy/hs/data-safety.htm (accessed 28 March 2011).
    • Further Guidance on Data and Safety Monitoring for Phase i and Ii Trials
  • 12
    • 0003770817 scopus 로고    scopus 로고
    • US National Institutes of Health Available at (accessed 28 March 2011)
    • US National Institutes of Health. NIH Policy for Data and Safety Monitoring, 10June1998. Available at http://grants1.nih.gov/grants/guide/notice- files/not98-084.html (accessed 28 March 2011).
    • (1998) NIH Policy for Data and Safety Monitoring, 10June
  • 19
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    • Council for International Organizations of Medical Sciences (CIOMS), in collaboration with the World Health Organization (WHO)Geneva Available at (accessed 28 March 2011)
    • Council for International Organizations of Medical Sciences (CIOMS), in collaboration with the World Health Organization (WHO)Geneva, Switzerland: International Ethical Guidelines for Biomedical Research Involving Human Subjects, 2002(ISBN 92 9036 075 5). Available at http://www.cioms.ch/ publications/layout-guide2002.pdf (accessed 28 March 2011).
    • Switzerland: International Ethical Guidelines for Biomedical Research Involving Human Subjects, 2002(ISBN 92 9036 075 5)
  • 21
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    • The use of external monitoring committees in clinical trials of the National Institute of Allergy and Infectious Diseases
    • Ellenberg SS, Myers MW, Blackwelder WC, Hoth DF. The use of external monitoring committees in clinical trials of the National Institute of Allergy and Infectious Diseases. Stat Med. 1993 ; 12 (5/6). 461-7 (Pubitemid 23119063)
    • (1993) Statistics in Medicine , vol.12 , Issue.5-6 , pp. 461-467
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  • 22
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    • A proposed charter for clinical trial data monitoring committees: Helping them to do their job well
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    • Grant, A.M.1    Altman, D.G.2


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