Considerations in Developing Data and Safety Monitoring Plans: A Framework

National Institutes of Health, Office of Human Subjects Research. Data and safety monitoring guidelines. Available at: http://wwov.nihtraining.com/ohsrsite/info/sheetl8.html (accessed September 28, 2004).

Cancer Therapy Evaluation Program's guidelines for monitoring of clinical trials for cooperative groups, CCOP research bases, and the Cancer Trials Support Unit (CTSU). Available at: http://ctep.info.nih.gov/monitoring/guidelines.html (accessed September 28, 2004).

National Institute of Arthritis and Musculoskeletal and Skin Diseases’ Data and Safety Monitoring Guidelines. Available at: http://www.niams.nih.gov/rtac/clinical/safe_monitoring_plan.htm (accessed September 28, 2004).

National Heart, Lung, and Blood Institute. Establishing data and safety monitoring boards (DSMBs) and observational study monitoring boards (OSMBs). Available at: http://www.nhlbi.nih.gov/funding/policies/dsmb_est.htm (accessed September 28, 2004).

Food and Drug Administration. Guidance for industry. Guideline for the monitoring of clinical investigations. Available at: http://www.fda.gov/ora/compliance_ref/bimo/clinguid.html (accessed September 28, 2004).

Food and Drug Administration. Guidance for clinical trial sponsors on the establishment and operation of clinical trial data monitoring committees. Available at: http://www.fda.gov/cber/gdlns/clindatmon.pdf (accessed September 28, 2004).

International Conference on Harmonization. Guidelines-“efficacy topics”- those related to clinical studies in human subjects. Available at: http://www.ich.org/urlgrpserver.jser?@_id=276&@_template=254 (accessed September 28, 2004).

National Institutes of Health. Policy for data and safety monitoring; release date: June 10, 1998. Available at: http://grants2.nih.gov/grants/guide/notice-files/not98-084.html (accessed September 28, 2004).

National Eye Institute. Guidelines for data and safety oversight of observational studies. Available at: http://www.nei.nih.gov/funding/datastudies.asp (accessed September 28, 2004).

Sydes M.R. , Spiegalhalter D.J. , Altman D.G. Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials. Clin Trials 2004; 1(1): 60–77.