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Volumn 5, Issue 1, 2008, Pages 49-55

Ensuring trial validity by data quality assurance and diversification of monitoring methods

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTICAL ERROR; COMPARATIVE STUDY; CONFERENCE PAPER; INFORMATION PROCESSING; METHODOLOGY; MONITORING; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROFESSIONAL STANDARD; QUALITY CONTROL; RISK ASSESSMENT; SAMPLE SIZE; TAXONOMY; VALIDITY;

EID: 40949130893     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774507087554     Document Type: Conference Paper
Times cited : (123)

References (10)
  • 1
    • 84971580244 scopus 로고
    • Absence of evidence is not evidence of absence
    • Altman DG, Bland JM. Absence of evidence is not evidence of absence. Br Med J 1995; 311: 485.
    • (1995) Br Med J , vol.311 , pp. 485
    • Altman, D.G.1    Bland, J.M.2
  • 2
    • 0035956651 scopus 로고    scopus 로고
    • Sifting the evidence - what's wrong with significance tests?
    • Sterne JAC, Davey Smith G. Sifting the evidence - what's wrong with significance tests? Br Med J 2001; 322: 226-31.
    • (2001) Br Med J , vol.322 , pp. 226-231
    • Sterne, J.A.C.1    Davey Smith, G.2
  • 3
    • 13844318810 scopus 로고    scopus 로고
    • A proposed charter for clinical trial data monitoring committees: Helping them do their job well
    • The DAMOCLES Study Group
    • The DAMOCLES Study Group. A proposed charter for clinical trial data monitoring committees: helping them do their job well. Lancet 2005; 365: 711-22.
    • (2005) Lancet , vol.365 , pp. 711-722
  • 4
    • 34548616839 scopus 로고    scopus 로고
    • Issues in data monitoring and interim analysis of trials (the DAMOCLES study)
    • Grant AM, Sydes M, McLeer S, et al. Issues in data monitoring and interim analysis of trials (the DAMOCLES study). Health Technol Assess 2005; 9: 1-238.
    • (2005) Health Technol Assess , vol.9 , pp. 1-238
    • Grant, A.M.1    Sydes, M.2    McLeer, S.3
  • 5
    • 0033619940 scopus 로고    scopus 로고
    • for the ISCB Subcommittee on Fraud
    • Buyse M, George SL, Evans S, et al. for the ISCB Subcommittee on Fraud. Statist Med 1999; 18: 3435-51.
    • (1999) Statist Med , vol.18 , pp. 3435-3451
    • Buyse, M.1    George, S.L.2    Evans, S.3
  • 7
    • 40949121657 scopus 로고    scopus 로고
    • MRC/DH joint project to codify good practice in publicly-funded UK clinical trials with medicines, accessed 4th April 2007
    • MRC/DH joint project to codify good practice in publicly-funded UK clinical trials with medicines. Workstream 4: Trial Management and Monitoring (http://www.ct-toolkit.ac.uk/_db/_documents/trial_MP.pdf (accessed 4th April 2007).
    • Workstream 4: Trial Management and Monitoring
  • 8
    • 23244436762 scopus 로고    scopus 로고
    • Are these data real? Statistical methods for detection of data fabrication in clinical trials
    • Al-Marzouki S, Evans S, Marshall T, et al.Are these data real? Statistical methods for detection of data fabrication in clinical trials. Br Med J 2005; 331: 267-70.
    • (2005) Br Med J , vol.331 , pp. 267-270
    • Al-Marzouki, S.1    Evans, S.2    Marshall, T.3
  • 9
    • 0030767941 scopus 로고    scopus 로고
    • European Stroke Prevention Study 2. Efficacy and safety data
    • The ESPS2 Group, Suppl
    • The ESPS2 Group. European Stroke Prevention Study 2. Efficacy and safety data. J Neurol Sciences 1997 (Suppl); 151: S1-S77.
    • (1997) J Neurol Sciences , vol.151
  • 10
    • 40949152128 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonized tripartite guidelines. Guideline for good clinical practice E6, accessed 26th April 2007
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonized tripartite guidelines. Guideline for good clinical practice E6. http://www. ich.org/LOB/media/MEDIA482.pdf (accessed 26th April 2007).


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.