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Volumn 39, Issue 1, 2005, Pages 53-61

Development of a charter for an endpoint assessment and adjudication committee

Author keywords

Committee charter; Data Monitoring Committee; Endpoint; Endpoint assessment; Endpoint Assessment and Adjudication; Pivotal trial

Indexed keywords

ALLOVECTIN 7; ANTINEOPLASTIC AGENT; BETA 2 MICROGLOBULIN; DACARBAZINE; HLA B7 ANTIGEN; IMMUNOMODULATING AGENT; PLASMID DNA; UNCLASSIFIED DRUG;

EID: 13844275035     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150503900107     Document Type: Review
Times cited : (8)

References (8)
  • 1
    • 13844257239 scopus 로고    scopus 로고
    • Bristol Made Deal with ImClone Without Key Data, Panel Says
    • June 15
    • Bristol Made Deal With ImClone Without Key Data, Panel Says. New York Times. June 15, 2002.
    • (2002) New York Times
  • 2
    • 0001184885 scopus 로고    scopus 로고
    • Good Clinical Practice: Consolidated Guideline
    • Good Clinical Practice: Consolidated Guideline (www.ich.org/pdfICH/e6. pdf). Federal Register. 62: 25691.
    • Federal Register , vol.62 , pp. 25691
  • 3
    • 13844299806 scopus 로고    scopus 로고
    • Title 21 §312.56 Code of Federal Regulations. Washington, DC: April 1, 2003
    • Title 21 §312.56 Code of Federal Regulations. Washington, DC: April 1, 2003.
  • 4
    • 0010750908 scopus 로고    scopus 로고
    • Draft Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees
    • Draft Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees. http://www.fda.gov/cber/ gdlns/clindatmon.pdf. Federal Register. 66:58151.
    • Federal Register , vol.66 , pp. 58151
  • 5
    • 13844282060 scopus 로고    scopus 로고
    • Title 21 Code of Federal Regulations. 50, 56, 312. Washington, DC: April 1, 2003
    • Title 21 Code of Federal Regulations. 50, 56, 312. Washington, DC: April 1, 2003.
  • 6
    • 13844280807 scopus 로고    scopus 로고
    • Title 21 Code of Federal Regulations 50.24 (a)(7)(iv). Washington, DC: April 1, 2003
    • Except where the informed consent requirement has been waived in emergency settings; Title 21 Code of Federal Regulations 50.24 (a)(7)(iv). Washington, DC: April 1, 2003.
  • 8
    • 0037108141 scopus 로고    scopus 로고
    • Monitoring clinical trials: Issues and controversies regarding confidentiality
    • Fleming TR, Ellenberg S, DeMets DL. Monitoring clinical trials: issues and controversies regarding confidentiality. Stat Med. 2002;21(19):2843-2851.
    • (2002) Stat Med. , vol.21 , Issue.19 , pp. 2843-2851
    • Fleming, T.R.1    Ellenberg, S.2    Demets, D.L.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.