Abstract
Effective quality risk management is fundamental to ensuring the protection of human subjects and reliability of clinical trial results during the conduct of clinical trials. Quality risk management supports effective delivery of clinical development programs and ultimately delivery of treatments to patients. Thus, risk management is a core element of an effective quality management system (QMS) as described in the TransCelerate Clinical Quality Management System (CQMS) conceptual framework. In addition, the landscape of quality risk management in clinical development evolves as regulatory authorities adopt elements of risk management to promote proactive quality management. This paper’s goal is to provide a conceptual framework for quality risk management as part of a CQMS. The components of a quality risk management program are explored including foundational elements and quality risk management methods appropriate for clinical development.
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References
Landray MJ, Grandinetti C, Kramer JM, et al. Clinical trials: rethinking how we ensure quality. Drug Information Journal. 2012;46(6):657–660.
European Medicines Agency (EMA). Reflection paper on risk-based quality management in clinical trials (EMA/269011/2013). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500155491.pdf. Published November 18, 2013. Accessed November 14, 2017.
Meeker-O’Connell A, Sam LM, Bergamo N, Little JA. TransCelerate’s clinical quality management system: from a vision to a conceptual framework. Therapeutic Innovation & Regulatory Science. 2016;50(4):397–413.
International Council on Harmonisation (ICH). ICH harmonised guideline: integrated addendum to ICH E6(R1): guideline for good clinical practice E6(R2) (Current Step 4 version). https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4_2016_1109.pdf. Published November 9, 2016. Accessed December 2, 2018.
Food and Drug Administration (FDA). Guidance for industry: oversight of clinical investigations—a risk-based approach to monitoring. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269919.pdf. Published August 2013. Accessed November 14, 2017.
TransCelerate. Risk-based monitoring position paper. http://www.transceleratebiopharmainc.com/wp-content/uploads/2016/01/TransCelerate-RBM-Position-Paper-FINAL-30MAY2013.pdf. Published 2013. Accessed November 14, 2017.
TransCelerate. Risk-based quality management: quality tolerance limits and risk reporting. http://www.transceleratebiopharmainc.com/wp-content/uploads/2017/09/Risk-Based-Quality-Managment.pdf. Published 2017. Accessed November 14, 2017.
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Suprin, M., Chow, A., Pillwein, M. et al. Quality Risk Management Framework: Guidance for Successful Implementation of Risk Management in Clinical Development. Ther Innov Regul Sci 53, 36–44 (2019). https://doi.org/10.1177/2168479018817752
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DOI: https://doi.org/10.1177/2168479018817752