1. Department of Health and Human Services. 42 CFR Part 11. Clinical trials registration and results information submission: Final rule. 2016.
https://www.federalregister.gov/documents/2016/09/21/2016-22129/clinical-trials-registration-and-results-information-submission
. Accessed 12 May 2018.
2. Zarin DA, Tse T, Williams RJ, et al. Trial reporting in ClinicalTrials. gov—the final rule. N Engl J Med. 2016;375(20):1998–2004.
https://doi.org/10.1056/NEJMsr1611785
.
3. Department of Health and Human Services. CFR Title 21, Section 312. Investigational new drug application, 2010.
4. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Annex I - Definitions (Rev 4), 2017.
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500143294.pdf
. Accessed 12 May 2018.
5. Department of Health and Human Services. CFR Title 21, Section 312.32. IND safety reporting. 2010.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=312
. Accessed 12 May 2018.