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Volumn 44, Issue 6, 2010, Pages 745-756

Risk-Based Source Data Verification Approaches: Pros and Cons

Author keywords

Data quality; Key variables; Keywords Source data verification; Risk based approach; Site monitoring

Indexed keywords


EID: 84864820040     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286151004400611     Document Type: Article
Times cited : (34)

References (9)
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    • 51049108119 scopus 로고    scopus 로고
    • Society for Clinical Data Management, Version 5
    • Society for Clinical Data Management.Good Clinical Data Management Practices, Version 5. 2005.
    • (2005) Good Clinical Data Management Practices
  • 4
    • 84874619896 scopus 로고    scopus 로고
    • Summary document-Workstream 2, Paper presented at meeting of Clinical Trials Transformation Initiative, Rockville, MD, November 4
    • Summary document-Workstream 2, Effective and efficient monitoring as a component of quality in the conduct of clinical trials. Paper presented at meeting of Clinical Trials Transformation Initiative, Rockville, MD, November 4, 2009.
    • (2009) Effective and efficient monitoring as a component of quality in the conduct of clinical trials
  • 7
    • 84874633371 scopus 로고    scopus 로고
    • US Food and Drug Administration, background to HSP/BIMO Workshop 5/10-5/11/07. April 26. (accessed May 25, 2009)
    • US Food and Drug Administration. Concept paper: quality in FDA-regulated clinical research; background to HSP/BIMO Workshop 5/10-5/11/07. April 26, 2007. http://www.fda.gov/oc/initiatives/criticalpath/clinicalresearch.html.(accessed May 25, 2009).
    • (2007) Concept paper: Quality in FDA-regulated clinical research
  • 8
    • 84874617659 scopus 로고    scopus 로고
    • International Conference on Harmonisation, November 9, (accessed February 1, 2009)
    • International Conference on Harmonisation. ICH Q9: ICH harmonised tripartite guideline: quality risk management. November 9, 2005. http://www.ich.org/LOB/media/MEDIA1957.pdf (accessed February 1, 2009).
    • (2005) ICH Q9: ICH harmonised tripartite guideline: Quality risk management


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.