Data acquisition, transfer, and management
ICH
The study used an electronic data capture (EDC) system developed by CliniOps (Fremont, CA, USA) to capture and transfer clinical data. De-identified clinical data were entered directly into tablet computers loaded with a mobile data management application called CliniTrial. The data were entered by designated, trained members of the UHAS research team on the day of enrollment or AE assessment. A parallel participant key (separate from CliniTrial and maintained at UHAS) linked study ID numbers with personal identifying information such as name and date of birth. The participant key was not shared with investigators or staff at Washington University.The EDC system employed is 21 CFR Part 11 compliant, and electronic case report forms (CRFs) were developed to comply with International Council for Harmonization on Good Clinical Practice (ICH GCP) and CDASH/CDISC standards [Laboratory test results (skin snip Mf counts, blood analysis data etc.) were recorded on paper forms and transferred into REDCap software (