1. [1]. US FDA. Guidance for clinical trial sponsors: establishment and operation of clinical trial data monitoring committees. Rockville: CBER/CDER/CDRH. US FDA; 2006.
2. [2]. DeMets DL, Fleming TR, Rockhold F, et al. Liability issues for data monitoring committee members. Clin Trials. 2004;1:525–31.
3. [3]. AICPA. Conceptual framework toolkit for independence, July 2022. https://us.aicpa.org/content/dam/aicpa/interestareas/professionalethics/resources/downloadabledocuments/toolkitsandaids/conceptual-framework-toolkit-for-independence-final.pdf
4. [4]. Wasserstein RL, Lazar NA. The ASA statement on p-values: context, process, and purpose. Am Stat. 2016;70(2):129–33. https://doi.org/10.1080/00031305.2016.1154108.
5. [5]. U.S. Food and Drug Administration. Guidance for industry. Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry. 2019; https://www.fda.gov/regulatory-information/search-fda-guidance-documents/adaptive-design-clinical-trials-drugs-and-biologics-guidance-industry