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Clinical Trials: Rethinking How We Ensure Quality

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References

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  3. International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline: quality risk management Q9, current step 4 version (ICHQ9). November 2005. https://doi.org/www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf. Accessed October 1, 2012.

  4. Morrison B, Behrman R, Landray M; on behalf of Clinical Trials Transformation Initiative Monitoring Project. Results and recommendations: effective and efficient monitoring as a component of quality assurance in the conduct of clinical trials. May 20, 2011. https://doi.org/www.ctti-clinicaltrials.org/project-topics/study-quality/effective-and-efficient-monitoring-as-a-component-of-quality/results-and-recommendations. Accessed October 1, 2012.

  5. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH). Guidance for industry: oversight of clinical investigations—a risk-based approach to monitoring. August 29, 2011 https://doi.org/www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269919.pdf. Accessed October 1, 2012.

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Authors and Affiliations

  1. Clinical Trial Service Unit & Epidemiological Studies Unit, University of Oxford, Richard Doll Building, Old Road Campus, Oxford, OX3 7LF, United Kingdom

    Martin J. Landray PhD, FRCP

  2. Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA

    Cheryl Grandinetti PharmD, Leslie Ball MD & Rachel E. Sherman MD, MPH

  3. Duke Translational Medicine Institute, Durham, NC, USA

    Judith M. Kramer MD, MS

  4. AstraZeneca, Wilmington, DE, USA

    Briggs W. Morrison MD

Authors
  1. Martin J. Landray PhD, FRCP
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  2. Cheryl Grandinetti PharmD
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  3. Judith M. Kramer MD, MS
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  4. Briggs W. Morrison MD
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  5. Leslie Ball MD
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  6. Rachel E. Sherman MD, MPH
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Corresponding author

Correspondence to Martin J. Landray PhD, FRCP.

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Landray, M.J., Grandinetti, C., Kramer, J.M. et al. Clinical Trials: Rethinking How We Ensure Quality. Ther Innov Regul Sci 46, 657–660 (2012). https://doi.org/10.1177/0092861512464372

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  • DOI: https://doi.org/10.1177/0092861512464372

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