1. International Council for Harmonisation (ICH). ICH harmonised guideline: integrated addendum to ICH E6(R1): guideline for good clinical practice E6(R2). 2016. https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf. Accessed 5 Dec 2019.
2. Risk-based quality management: quality tolerance limits and risk reporting. TransCelerate website. https://www.transceleratebiopharmainc.com/wp-content/uploads/2017/09/Risk-Based-Quality-Managment.pdf. Published 2017. Accessed 5 Dec 2019.
3. International Council for Harmonisation (ICH). ICH harmonised guideline: general considerations for clinical studies E8(R1). Draft version endorsed on May 8, 2019. https://database.ich.org/sites/default/files/E8-R1_EWG_Draft_Guideline.pdf. Accessed 5 Dec 2019.
4. 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. 2019;53:36–44.
5. https://www.ctti-clinicaltrials.org/files/principles_document_finaldraft_19may15_1.pdf