Clinical Events Adjudication in the Digital Age | Page 9

REFERENCES 1. US Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, and Center for Devices and Radiological Health. Guidance for clinical trial sponsors: establishment and operation of clinical trial data monitoring committees. March 2006. Available at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm127069.htm 2. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research. Guidance for industry: E6 good clinical practice: consolidated guidance. April 1996. Available at http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf