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Volumn 41, Issue 5, 2015, Pages 398-403

Analysis of warning letters issued by the US Food and Drug Administration to clinical investigators, institutional review boards and sponsors: A retrospective study

Author keywords

[No Author keywords available]

Indexed keywords

ETHICS; FINANCIAL MANAGEMENT; FOOD AND DRUG ADMINISTRATION; HUMAN; PERSONNEL; PROFESSIONAL STANDARD; RETROSPECTIVE STUDY; STANDARDS; UNITED STATES; WRITING;

EID: 84929515125     PISSN: 03066800     EISSN: 14734257     Source Type: Journal    
DOI: 10.1136/medethics-2013-101829     Document Type: Article
Times cited : (13)

References (20)
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    • Wolf LE, Lo B. What about the ethics? West J Med 1999;171:365-6.
    • (1999) West J Med , vol.171 , pp. 365-366
    • Wolf, L.E.1    Lo, B.2
  • 2
    • 84929505601 scopus 로고    scopus 로고
    • 5-7 May, (accessed 12 Feb 2013)
    • Alliance for Human Research Protection. Conflicts of Interests in Clinical Trials. 5-7 May, 2002. http://www.ahrp.org/cms/content/view/230/144/ (accessed 12 Feb 2013).
    • (2002) Conflicts of Interests in Clinical Trials
  • 4
    • 20444389188 scopus 로고    scopus 로고
    • Human subjects issues and IRB review in practice based research
    • Wolf LE, Ferrara Walden J, Lo B. Human subjects issues and IRB review in practice based research. Ann Fam Med 2005;3(Supp 1):S30-37.
    • (2005) Ann Fam Med , vol.3 , pp. S30-S37
    • Wolf, L.E.1    Ferrara Walden, J.2    Lo, B.3
  • 6
    • 84929516345 scopus 로고    scopus 로고
    • US Food and Drug Administration, Aug, (accessed 18 May 2014)
    • Raub WF. Efforts to Protect Human Research Subjects. US Food and Drug Administration. Aug 2009. http://www.fda.gov/newsevents/testimony/ucm114943. htm (accessed 18 May 2014).
    • (2009) Efforts to Protect Human Research Subjects
    • Raub, W.F.1
  • 12
    • 84904725176 scopus 로고    scopus 로고
    • Are institutional review boards prepared for active continuing review?
    • Shetty YC, Jadhav KS, Saiyed AA, et al. Are institutional review boards prepared for active continuing review? Perspect Clin Res. 2014;5(1):11-5.
    • (2014) Perspect Clin Res. , vol.5 , Issue.1 , pp. 11-15
    • Shetty, Y.C.1    Jadhav, K.S.2    Saiyed, A.A.3
  • 14
    • 84929518174 scopus 로고    scopus 로고
    • Sep, (accessed 28 Jan 2013)
    • US Food and Drug Administration. Science&Research: Compliance&Enforcement. Sep 2013. http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ ComplianceEnforcement/default.htm (accessed 28 Jan 2013).
    • (2013) Science&Research: Compliance&Enforcement
  • 16
    • 4544303395 scopus 로고    scopus 로고
    • A study of warning letters issued to clinical investigators by the United States Food and Drug Administration
    • Bramstedt AK. A study of warning letters issued to clinical investigators by the United States Food and Drug Administration. Clin Invest Med 2004;27(3):129-34.
    • (2004) Clin Invest Med , vol.27 , Issue.3 , pp. 129-134
    • Bramstedt, A.K.1
  • 17
    • 14144252850 scopus 로고    scopus 로고
    • A study of warning letters issued to institutional review boards by the United States Food and Drug Administration
    • Bramstedt AK, Kassimatis K. A study of warning letters issued to institutional review boards by the United States Food and Drug Administration. Clin Invest Med 2004;27(6):316-23.
    • (2004) Clin Invest Med , vol.27 , Issue.6 , pp. 316-323
    • Bramstedt, A.K.1    Kassimatis, K.2
  • 18
    • 84855181778 scopus 로고    scopus 로고
    • A study of warning letters issued to clinical investigators and institutional review boards by the United States Food and Drug Administration
    • Gogtay NJ, Doshi BM, Kannan S, et al. A study of warning letters issued to clinical investigators and institutional review boards by the United States Food and Drug Administration. Indian J Med Ethics 2011;8(4):211-14.
    • (2011) Indian J Med Ethics , vol.8 , Issue.4 , pp. 211-214
    • Gogtay, N.J.1    Doshi, B.M.2    Kannan, S.3
  • 20
    • 1642578306 scopus 로고    scopus 로고
    • What do we really know about conflicts of interest in biomedical research?
    • Warner TD, Gluck JP. What do we really know about conflicts of interest in biomedical research? Psychopharmacology (Berl) 2003;171(1):36-46.
    • (2003) Psychopharmacology (Berl) , vol.171 , Issue.1 , pp. 36-46
    • Warner, T.D.1    Gluck, J.P.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.