1. ICH Guideline E2F, Development safety update report. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2F/Step4/E2F_Step_4.pdf. Published 2010. Accessed June 16, 2015.
2. ICH Guideline E2F, Example development safety update report. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2F/Examples_DSUR/E2F_Example_Commercial_DSUR.pdf. Published 2010. Accessed June 16, 2015.
3. ICH Guideline E2A, Clinical safety data management: definitions and standards for expedited reporting. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2A/Step4/E2A_Guideline.pdf. Published 1994. Accessed June 16, 2015.
4. MedDRA Hierarchy. http://www.meddra.org/how-to-use/basics/hierarchy. Accessed June 16, 2015.
5. European Medicines Agency policy on publication of clinical data for medicinal products for human use. EMA/240810/2013. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/10/WC500174796.pdf. Published October 2, 2014. Accessed June 16, 2015.