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Volumn 11, Issue 2, 2007, Pages 128-137

Developing and implementing a comprehensive clinical QA audit program

Author keywords

Audit; Clinical trial; Good clinical practice (GCP); Inspection; Quality assurance

Indexed keywords

COMPUTER SYSTEM; DRUG SURVEILLANCE PROGRAM; GOOD CLINICAL PRACTICE; HEALTH CARE MANAGEMENT; HEALTH PROGRAM; HUMAN; MANAGED CARE; MEDICAL AUDIT; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; RISK MANAGEMENT; SIGNAL DETECTION;

EID: 40349103523     PISSN: 10878378     EISSN: 10991786     Source Type: Journal    
DOI: 10.1002/qaj.420     Document Type: Review
Times cited : (10)

References (13)
  • 1
    • 40349110033 scopus 로고    scopus 로고
    • ICH Harmonised Tripartite Guideline E6(R1) Guideline for Good Clinical Practice. 10 June 1996: http://www.ich.org/LOB/media/MEDIA482.pdf (last checked: 6 August 2007).
    • ICH Harmonised Tripartite Guideline E6(R1) Guideline for Good Clinical Practice. 10 June 1996: http://www.ich.org/LOB/media/MEDIA482.pdf (last checked: 6 August 2007).
  • 2
    • 40349093894 scopus 로고    scopus 로고
    • Clinical quality assurance bench-marking
    • June
    • Gertzen H. Clinical quality assurance bench-marking. Applied Clinical Trials 2004; June issue: 70-82.
    • (2004) Applied Clinical Trials , Issue.70-82
    • Gertzen, H.1
  • 4
    • 1442314348 scopus 로고    scopus 로고
    • Winchell T. Start up: CQA. Qual Assur J 2004; 8(1): 13-20.
    • Winchell T. Start up: CQA. Qual Assur J 2004; 8(1): 13-20.
  • 7
    • 40349105046 scopus 로고    scopus 로고
    • FDA Code of Federal Regulation Part 312 Investigational New Drug Application.
    • FDA Code of Federal Regulation Part 312 Investigational New Drug Application.
  • 9
    • 40349086307 scopus 로고    scopus 로고
    • FDA Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. March 2005. http://www.fda.gov/cber/gdlns/ pharmacovig.htm; Guidance for Industry E2E Pharmacovigilance Planning. April 2005. http://www.fda.gov/cber/gdlns/ichpvp.htm.
    • FDA Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. March 2005. http://www.fda.gov/cber/gdlns/ pharmacovig.htm; Guidance for Industry E2E Pharmacovigilance Planning. April 2005. http://www.fda.gov/cber/gdlns/ichpvp.htm.
  • 10
    • 0033944325 scopus 로고    scopus 로고
    • Hard to find - hard to develop - hard to keep. Part I: Criteria and methods for candidate selection
    • Hattemer-Apostel R. GCP Auditors: Hard to find - hard to develop - hard to keep. Part I: criteria and methods for candidate selection. Qual Assur J 2000; 4(1): 3-8.
    • (2000) Qual Assur J , vol.4 , Issue.1 , pp. 3-8
    • Hattemer-Apostel, R.1    Auditors, G.C.P.2
  • 11
    • 0033814951 scopus 로고    scopus 로고
    • Hard to find - hard to develop - hard to keep. Part II: Initial training requirements for auditors
    • Hattemer-Apostel R. GCP Auditors: Hard to find - hard to develop - hard to keep. Part II: initial training requirements for auditors. Qual Assur J 2000; 4(3): 123-135.
    • (2000) Qual Assur J , vol.4 , Issue.3 , pp. 123-135
    • Hattemer-Apostel, R.1    Auditors, G.C.P.2
  • 12
    • 0035093247 scopus 로고    scopus 로고
    • Hard to find - hard to develop - hard to keep. Part III: Continuous education and further development
    • Hattemer-Apostel R. GCP Auditors: Hard to find - hard to develop - hard to keep. Part III: continuous education and further development. Qual Assur J 2001; 5(1): 3-11.
    • (2001) Qual Assur J , vol.5 , Issue.1 , pp. 3-11
    • Hattemer-Apostel, R.1    Auditors, G.C.P.2
  • 13
    • 1442335953 scopus 로고    scopus 로고
    • A career in clinical quality assurance
    • 2nd edn, Stonier PD ed, Wiley: Chichester, UK, ISBN 0-470-84328-4
    • Hattemer-Apostel R. A career in clinical quality assurance. In Careers in the Pharmaceutical Industry (2nd edn), Stonier PD (ed.). Wiley: Chichester, UK, 2003; 187-202 (ISBN 0-470-84328-4).
    • (2003) Careers in the Pharmaceutical Industry , pp. 187-202
    • Hattemer-Apostel, R.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.