1. International Conference on Harmonisation of technical requirements for pharmaceuticals for human use (ICH). Guideline for good clinical practice E6(R2) 2018 Accessed 7 Feb 2019. Available from: https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice. Accessed 30 Dec 2019.
2. Federal Drugs Agency. Guidance for industry. Oversight of clinical investigations —a risk-based approach to monitoring. Accessed 7 Feb 2019. Available from: https://www.fda.gov/downloads/Drugs/Guidances/UCM269919.pdf
3. European Medicines Agency. Reflection paper on risk based quality management in clinical trials. Accessed 7 Feb 2019. Available from: https://www.ema.europa.eu/documents/scientific-guideline/reflection-paper-risk-based-quality-management-clinical-trials_en.pdf
4. Brosteanu O, Schwarz G, Houben P, Paulus U, Strenge-Hesse A, Zettelmeyer U, et al. Risk-adapted monitoring is not inferior to extensive on-site monitoring: Results of the ADAMON cluster-randomised study. Clin Trials. 2017;14(6):584–96.
5. Fougerou-Leurent C, Laviolle B, Bellissant E. Cost-effectiveness of full versus targeted monitoring of randomized controlled trials. Fund Clin Pharmacol. 2018;32(supplement):49.