Data citation

1. E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) March 2018 https://www.fda.gov/downloads/Drugs/Guidances/UCM464506.pdf 2. 21CFR312.57 : Recordkeeping and record retention https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.57 3. 21CFR part 11, Electronic records; electronic signatures https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11