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Volumn 9, Issue 2, 2012, Pages 257-264

The potential for central monitoring techniques to replace on-site monitoring: Findings from an international multi-centre clinical trial

Author keywords

[No Author keywords available]

Indexed keywords

MICROBICIDE; PLACEBO;

EID: 84861796027     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774511427325     Document Type: Article
Times cited : (67)

References (19)
  • 1
    • 84861807672 scopus 로고    scopus 로고
    • European Medicines Agency ICH Topic E 6 (R1)
    • European Medicines Agency ICH Topic E 6 (R1). Guideline for Good Clinical Practice July 2002 CPMP/ICH/135/95. Available at http://www.ema.europa.eu/docs/ en-GB/document-library/Scientific-guideline/2009/09/WC500002874.pdf
    • Guideline for Good Clinical Practice July 2002 CPMP/ICH/135/95
  • 2
    • 22244434170 scopus 로고    scopus 로고
    • The Good Clinical Practice guideline: A bronze standard for clinical research
    • Grimes D, Hubacher D, Nanda K, et al. The Good Clinical Practice guideline: A bronze standard for clinical research. Lancet. 2005 ; 366: 172-4
    • (2005) Lancet , vol.366 , pp. 172-174
    • Grimes, D.1    Hubacher, D.2    Nanda, K.3
  • 3
    • 40949108412 scopus 로고    scopus 로고
    • Specific barriers to the conduct of randomised trials
    • Duley L, Antman K, Arena J, et al. Specific barriers to the conduct of randomised trials. Clin Trials. 2008 ; 5: 40-8
    • (2008) Clin Trials , vol.5 , pp. 40-48
    • Duley, L.1    Antman, K.2    Arena, J.3
  • 4
    • 40949124713 scopus 로고    scopus 로고
    • Sensible guidelines for the conduct of large randomised trials
    • Yusuf S, Bosch J, Devereaux P, et al. Sensible guidelines for the conduct of large randomised trials. Clin Trials. 2008 ; 5: 38-9
    • (2008) Clin Trials , vol.5 , pp. 38-39
    • Yusuf, S.1    Bosch, J.2    Devereaux, P.3
  • 5
    • 34447314711 scopus 로고    scopus 로고
    • Clinical trials bureaucracy: Unintended consequences of well-intentioned policy
    • Califf R. Clinical trials bureaucracy: Unintended consequences of well-intentioned policy. Clin Trials. 2006 ; 3: 496-502
    • (2006) Clin Trials , vol.3 , pp. 496-502
    • Califf, R.1
  • 6
    • 0038369246 scopus 로고    scopus 로고
    • Toward protecting the safety of participants in clinical trials
    • Califf R, Morse M, Wittes J, et al. Toward protecting the safety of participants in clinical trials. Contr Clin Trials. 2003 ; 24 (3). 256-71
    • (2003) Contr Clin Trials , vol.24 , Issue.3 , pp. 256-271
    • Califf, R.1    Morse, M.2    Wittes, J.3
  • 7
    • 0030703193 scopus 로고    scopus 로고
    • Developing systems for cost effective auditing of clinical trials
    • Califf R, Karnash S, Woodlief L. Developing systems for cost effective auditing of clinical trials. Contr Clin Trials. 1997 ; 18: 651-60
    • (1997) Contr Clin Trials , vol.18 , pp. 651-660
    • Califf, R.1    Karnash, S.2    Woodlief, L.3
  • 8
    • 40949130893 scopus 로고    scopus 로고
    • Ensuring trial validity by data quality assurance and diversification of monitoring methods
    • Baigent C, Harrell F, Buyse M, Emberson JR, Altman D. Ensuring trial validity by data quality assurance and diversification of monitoring methods. Clin Trials. 2008 ; 5 (1). 49-55
    • (2008) Clin Trials , vol.5 , Issue.1 , pp. 49-55
    • Baigent, C.1    Harrell, F.2    Buyse, M.3    Emberson, J.R.4    Altman, D.5
  • 9
    • 84861828370 scopus 로고    scopus 로고
    • On behalf of the Optimon Collaborative Group. Validation of a risk assessment scale and a risk-adapted monitoring plan for academic clinical research studies-The Pre-Optimon study
    • Journot V, Pignon JP, Gaultier C, et al. On behalf of the Optimon Collaborative Group. Validation of a risk assessment scale and a risk-adapted monitoring plan for academic clinical research studies-The Pre-Optimon study. Contemp Clin Trials. 2010 ;:
    • (2010) Contemp Clin Trials
    • Journot, V.1    Pignon, J.P.2    Gaultier, C.3
  • 10
    • 77149136737 scopus 로고    scopus 로고
    • Risk analysis and risk adapted on-site monitoring in non-commercial clinical trials
    • Brosteanu O, Houben P, Ihrig K, et al. Risk analysis and risk adapted on-site monitoring in non-commercial clinical trials. Clin Trials. 2009 ; 6: 585-96
    • (2009) Clin Trials , vol.6 , pp. 585-596
    • Brosteanu, O.1    Houben, P.2    Ihrig, K.3
  • 11
    • 39049084310 scopus 로고    scopus 로고
    • ACTION (A Coronary disease Trial Investigating Outcome with Nifedipine GITS) investigators. Quality management of a large randomised double-blind multi-centre trial: The ACTION experience
    • Kirwan B, Lubsen J, de Brouwer S, et al. ACTION (A Coronary disease Trial Investigating Outcome with Nifedipine GITS) investigators. Quality management of a large randomised double-blind multi-centre trial: The ACTION experience. Contemp Clin Trials. 2008 ; 29 (2). 259-69
    • (2008) Contemp Clin Trials , vol.29 , Issue.2 , pp. 259-269
    • Kirwan, B.1    Lubsen, J.2    De Brouwer, S.3
  • 12
    • 41249099896 scopus 로고    scopus 로고
    • European Association for Research in Oncology. Impact of on-site initiation visits on patient recruitment and data quality in a randomised trial of adjuvant chemotherapy for breast cancer
    • Liénard JL, Quinaux E, Fabre-Guillevin E, et al. European Association for Research in Oncology. Impact of on-site initiation visits on patient recruitment and data quality in a randomised trial of adjuvant chemotherapy for breast cancer. Clin Trials. 2006 ; 3 (5). 486-92
    • (2006) Clin Trials , vol.3 , Issue.5 , pp. 486-492
    • Liénard, J.L.1    Quinaux, E.2    Fabre-Guillevin, E.3
  • 13
    • 59449104103 scopus 로고    scopus 로고
    • The other side of clinical trial monitoring; Assuring data quality and procedural adherence
    • Williams G. The other side of clinical trial monitoring; assuring data quality and procedural adherence. Clin Trials. 2006 ; 3 (6). 530-7
    • (2006) Clin Trials , vol.3 , Issue.6 , pp. 530-537
    • Williams, G.1
  • 14
    • 1542442432 scopus 로고    scopus 로고
    • Promoting good clinical practices in the conduct of clinical trials: Experiences in the Department of Veterans Affairs Cooperative Studies Program
    • Sather M, Raisch D, Haakenson C, Beckelew J, Feussner J. Promoting good clinical practices in the conduct of clinical trials: Experiences in the Department of Veterans Affairs Cooperative Studies Program. Contr Clin Trials. 2003 ; 24 (5). 570-84
    • (2003) Contr Clin Trials , vol.24 , Issue.5 , pp. 570-584
    • Sather, M.1    Raisch, D.2    Haakenson, C.3    Beckelew, J.4    Feussner, J.5
  • 15
    • 0021125097 scopus 로고
    • Site visits in a multicentre ophthalmic clinical trial
    • Cassel G, Ferris F. Site visits in a multicentre ophthalmic clinical trial. Contr Clin Trials. 1984 ; 5 (3). 251-62
    • (1984) Contr Clin Trials , vol.5 , Issue.3 , pp. 251-262
    • Cassel, G.1    Ferris, F.2
  • 17
    • 25844507604 scopus 로고    scopus 로고
    • Quality assurance in the EORTC phase III randomised 'boost vs. no boost' trial for breast conserving therapy: Comparison of the results of two individual case reviews performed early and late during the accrual period
    • Poortmans P, Ataman F, Davis J, et al. Quality assurance in the EORTC phase III randomised 'boost vs. no boost' trial for breast conserving therapy: Comparison of the results of two individual case reviews performed early and late during the accrual period. Radiother Oncol. 2005 ; 76 (3). 278-84
    • (2005) Radiother Oncol , vol.76 , Issue.3 , pp. 278-284
    • Poortmans, P.1    Ataman, F.2    Davis, J.3
  • 18
    • 71149085990 scopus 로고    scopus 로고
    • Microbicides Development Programme: Design of a phase III trial to measure the efficacy of the vaginal microbicide PRO 2000/5 for HIV prevention
    • Nunn A, McCormack S, Crook A, et al. Microbicides Development Programme: Design of a phase III trial to measure the efficacy of the vaginal microbicide PRO 2000/5 for HIV prevention. Trials. 2009 ; 10: 99
    • (2009) Trials , vol.10 , pp. 99
    • Nunn, A.1    McCormack, S.2    Crook, A.3
  • 19
    • 77958104207 scopus 로고    scopus 로고
    • PRO2000 vaginal gel for prevention of HIV-1 infection (Microbicides Development Programme 301): A phase 3, randomised, double-blind, parallel group trial
    • McCormack S, Ramjee G, Kamali A, et al. PRO2000 vaginal gel for prevention of HIV-1 infection (Microbicides Development Programme 301): A phase 3, randomised, double-blind, parallel group trial. Lancet. 2010 ; 376: 1329-37
    • (2010) Lancet , vol.376 , pp. 1329-1337
    • McCormack, S.1    Ramjee, G.2    Kamali, A.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.