ICH Harmonised Tripartite Guidelines (1998) “E9 Statistical Principles for Clinical Trials” #https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf#
Friedman, L. M., Furberg, C. D., et al. (2015) “Fundamentals of Clinical Trials” 5th ed., Springer
Glantz, S. A. (2012) Primer of Biostatistics, 7th ed., McGraw-Hill
Society for Clinical Data Management, (2013) “Good Clinical Data Management Practices” #https://www.scdm.org/publications/gcdmp/#
Higgins, Julian PT, et al., eds. John Wiley & Sons (2019) Cochrane handbook for systematic reviews of interventions. #https://training.cochrane.org/handbook/current#