1. International Council for Harmonisation Good Clinical Practice (ICH GCP) Relevant sections on monitoring are 5.18, 5.20.2, 5.1.2, 5.6.3, 5.15.2,5.15.1, 6.10, 4.1.4, 6.3.3 1996 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html
2. World Medical Association (WMA) Declaration of Helsinki 2013 http://www.wma.net/en/30publications/10policies/b3/
3. National Institute for Health Research (NIHR) Clinical Trials Toolkit Trial management and monitoring 2012 http://www.ct-toolkit.ac.uk/routemap/trial-management-and-monitoring
4. Medical Research Council (MRC) Guidelines for GCP 1998 https://www.mrc.ac.uk/documents/pdf/good-clinical-practice-in-clinical-trials/
5. A proposed charter for clinical trial data monitoring committees: helping them to do their job well;DAMOCLES study group;Lancet,2005