Clinical Trials

CDISC (SDTM, ADaM, CDASH) is the standard for clinical trial data required for regulatory submissions to the FDA and EMA (the US and European medicines regulators). It is the data infrastructure for interventional research conducted through ECRIN and NeurATRIS. Trial registration is mandatory in ClinicalTrials.gov and the EU CTIS. Individual patient data from completed trials can be shared via platforms such as VIVLI and YODA Project.