References
- Council for International Organizations of Medical Sciences. 2005. Management of safety information from clinical trials: Report of CIOMS working group VI. Geneva: Council for International Organizations of Medical Sciences.
- U.S. Food and Drug Administration 2012. Safety reporting requirements for INDs and BA/BE studies. Guidance for industry and investigators. Rockville, MD: U.S. Department of Health and Human Services.
- U.S. Food and Drug Administration 2015. Safety assessment for IND safety reporting. Guidance for industry and investigators. Rockville, MD: U.S. Department of Health and Human Services.