参考文献：

[1] ARCO. Establishing Risk-Based Monitoring within a Quality-Based System as “Best Practice” for Clinical Studies. Oct 17, 2019. Retrieved Oct 19, 2019 from https://www.acrohealth.org/rbqm-report/

[2] FDA. Guidance for Industry. Oversight of Clinical Investigations — A Risk-Based Approach. August, 2013. Retrieved Oct 24, 2019 from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oversight-clinical-investigations-risk-based-approach-monitoring

[3] FDA. Guidance for Industry. E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1). Mar, 2018. Retrieved Oct, 22 from https://www.fda.gov/media/93884/download

[4] FDA. A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry DRAFT GUIDANCE. Mar, 2019. Retrieved Oct 22, 2019 from https://www.fda.gov/media/121479/download

[5] TransCelerate. TransCelerate Risk-Based Monitoring – The Approach. 2017. Retrieved Oct 22, 2019 from http://www.phusewiki.org/wiki/images/7/71/Phuse_TransCelerate_Overview_LoriConvy.pdf

[6] Julie Dietrich, Annemarie Forrest, Ann Meeker-O’Connell. QbD in Clinical Trials: a Focused Approach to Quality Assurance and Risk Management. July 10, 2018. Retrieved Oct 22, 2019 from https://www.clinicalleader.com/doc/qbd-in-clinical-trials-a-focused-approach-to-quality-assurance-and-risk-management-0001

[7] FDA. Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations. Workshop July 2019. Retrieved Oct 22, 2019 from https://www.youtube.com/watch?time_continue=2851&v=xp8Wp0Upuvo.

[8] EMA. Reflection paper on risk based quality management in clinical trials. Nov 18, 2013. Retrieved Oct 23, 2019 from https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-risk-based-quality-management-clinical-trials_en.pdf

[9] Hurley C, Sinnott C, Clarke M, et al. Perceived barriers and facilitators to Risk Based Monitoring in academic-led clinical trials: a mixed methods study. Trials. Sep 11, 2017; 18:423.

[10] King L. Risk-Based Monitoring: Understanding The Future Of Clinical Trial Monitoring. Clinical Leader. July 29, 2015. Retrieved Oct 23, 2019 from https://www.clinicalleader.com/doc/risk-based-monitoring-understanding-the-future-of-clinical-trial-monitoring-0001

[11] Ann Meeker-O’Connell, Leslie M. Sam, Nanci Bergamo, et al. TransCelerate’s Clinical Quality Management System: From a Vision to a Conceptual Framework. Therapeutic Innovation & Regulatory Science. 2016, Vol. 50(4) 397-413. DOI: 10.1177/2168479016651300

小编推荐：
礼来公布Verzenio三期monarchE临
新管理法实施 药品上市许可持有
全球首份新冠肺炎病理报告发布
CBNData联合健美生发布《2020年

中国养生网()