1. FDA Guidance for Industry and Investigators : Safety Reporting Requirements for INDs and BA / BE Studies Food and Drug Administration 2012 http://www.fda.gov/downloads/ Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM227351.pdf
2. The FDA's final rule on expedited safety reporting: Statistical considerations;Wittes;Statistics in Biopharmaceutical Research,2015
3. Continuous safety monitoring for randomized controlled clinical trials with blinded treatment information;Ball;Contemporary Clinical Trials,2011
4. Gould , AL Wang , WB Estimating event rate differences using data from blinded trials: The canary in the coal mine 2015 https://www.amstat.org/meetings/jsm/2015/onlineprogram/AbstractDetails.cfm?abstractid=315409
5. Wen S Ball G Dey J Bayesian monitoring of safety signals in blinded clinical trial data Annals of Public Health and Research 2015 http://www.jscimedcentral.com/PublicHealth/ publichealth-2-1018.pdf