1. Landray MJ, Grandinetti C, Kramer JM, et al. Clinical trials: rethinking how we ensure quality. Drug Information Journal. 2012;46(6):657–660.
2. 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.
3. 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.
4. 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.
5. 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.