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Volumn 5, Issue 3, 2008, Pages 277-282

Enhancing communication among data monitoring committees and institutional review boards

Author keywords

[No Author keywords available]

Indexed keywords

CIVIL RIGHTS; DATA COLLECTION METHOD; HEALTH CARE POLICY; INFORMATION DISSEMINATION; INFORMATION PROCESSING; INSTITUTIONAL REVIEW; INTERPERSONAL COMMUNICATION; MEDICAL RESEARCH; PATIENT SAFETY; PRIORITY JOURNAL; PROFESSIONAL STANDARD; RESEARCH ETHICS; REVIEW; ARTICLE; HUMAN; HUMAN EXPERIMENT; STANDARD; UNITED STATES;

EID: 54549084479     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774508091262     Document Type: Review
Times cited : (13)

References (14)
  • 1
    • 0026427327 scopus 로고
    • Federal policy for the protection of human subjects
    • 45 CFR 46
    • 45 CFR 46. Federal policy for the protection of human subjects. Fed Regist 1991; 56(117): 28003-18.
    • (1991) Fed Regist , vol.56 , Issue.117 , pp. 28003-28018
  • 2
    • 0031611062 scopus 로고    scopus 로고
    • Toward a more comprehensive approach to protecting human subjects: The interface of data safety and monitoring boards and institutional review boards in randomized clinical trials
    • Gordon V., Sugarman J., Kass N. Toward a more comprehensive approach to protecting human subjects: The interface of data safety and monitoring boards and institutional review boards in randomized clinical trials. IRB 1998; 20(1): 1-5.
    • (1998) IRB , vol.20 , Issue.1 , pp. 1-5
    • Gordon, V.1    Sugarman, J.2    Kass, N.3
  • 5
    • 33744813860 scopus 로고    scopus 로고
    • Issues in regulatory guidelines for data monitoring committees
    • DeMets DL, Califf RM, Dixon DO et al. Issues in regulatory guidelines for data monitoring committees. Clin Trials 2004; 1: 162-69.
    • (2004) Clin Trials , vol.1 , pp. 162-169
    • DeMets, D.L.1    Califf, R.M.2    Dixon, D.O.3
  • 6
    • 0003770817 scopus 로고    scopus 로고
    • National Institutes of Health. June Available at Accessed January 11, 2007
    • National Institutes of Health. NIH policy for data and safety monitoring. June 1998; Available at: http://grants.nih.gov/grants/guide/ notice-files/not98-084.html. Accessed January 11, 2007.
    • (1998) NIH Policy for Data and Safety Monitoring
  • 8
    • 33746242241 scopus 로고    scopus 로고
    • Guidelines for data and safety monitoring for clinical trials not requiring traditional data monitoring committees
    • Society for Clinical Trials Working Group on Data Monitoring
    • Society for Clinical Trials Working Group on Data Monitoring, Dixon DO, Freedman RS, Herson J., et al. Guidelines for data and safety monitoring for clinical trials not requiring traditional data monitoring committees. Clin Trials 2006; 3: 314-19.
    • (2006) Clin Trials , vol.3 , pp. 314-319
    • Dixon, D.O.1    Freedman, R.S.2    Herson, J.3
  • 11
    • 71449104645 scopus 로고    scopus 로고
    • National Institutes of Health. June available at Accessed January 11, 2007
    • National Institutes of Health. Further guidance on data and safety monitoring for phase I and phase II Trials. June 2000; available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Accessed January 11, 2007.
    • (2000) Further Guidance on Data and Safety Monitoring for Phase I and Phase II Trials
  • 12
    • 34748860155 scopus 로고    scopus 로고
    • Food and Drug Administration, Department of Health and Human Services. draft guidance (Nov. 2001). May available at Accessed March 20, 2007
    • Food and Drug Administration, Department of Health and Human Services. Guidance for clinical trials sponsors: Establishment and operation of clinical trial data monitoring committees, draft guidance (Nov. 2001). May 2002; available at: http://www.fda.gov/cber/gdlns/clindatmon.htm. Accessed March 20, 2007.
    • (2002) Guidance for Clinical Trials Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
  • 14
    • 0742266629 scopus 로고    scopus 로고
    • On behalf of the Consortium to Examine Clinical Research Ethics. A special scrutiny: A targeted form of research protocol review
    • Levine C., Faden R., Grady C., et al. On behalf of the Consortium to Examine Clinical Research Ethics. A special scrutiny: A targeted form of research protocol review. Annals of Internal Medicine 2004; 140(3): 220-23.
    • (2004) Annals of Internal Medicine , vol.140 , Issue.3 , pp. 220-223
    • Levine, C.1    Faden, R.2    Grady, C.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.