1. US Food and Drug Administration. Guidance for industry and investigators: Safety reporting requirements for INDs and BA/BE studies. https://www.fda.gov/downloads/Drugs/Guidances/UCM227351.pdf. Published 2012.
2. US Food and Drug Administration. Final rule, investigational new drug safety reporting requirements for human drug and biologic products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Fed Regist. https://www.gpo.gov/fdsys/pkg/FR-2010-09-29/pdf/2010-24296.pdf. Published September 2010.
3. US Food and Drug Administration. Guidance for industry: safety assessment for IND safety reporting (draft). https://www.fda.gov/downloads/drugs/guidances/ucm477584.pdf. Published 2015.
4. Chuang-Stein C. Safety analysis in controlled clinical trials. Drug Inform J. 1998;32:1363S–1372S.
5. International Council for Harmonization. M4 S: The CTD—Safety, 2001. https://www.fda.gov/downloads/drugs/guidances/ucm073299.pdf.