For most of our trials, CTRU Leeds use MACRO for data capture, validation and management.
MACRO is Elsevier's industry-standard clinical research database and data capture system. It is fully compliant with EU Clinical Trials Regulation, ICH E6 Good Clinical Practice guideline, US FDA 21 CFR Part 11, with regular audits to confirm continued compliance.
It has been proven in commercial and non-profit environments for 20 years, and CTRU Leeds has been using it since 2006
CTRU Leeds uses its own proprietary system, Gen24, for automated registration and randomisation of trial participants.
Gen24 is a 24-hour service, which includes both automated telephone and web-based systems