eudract - Creates Safety Results Summary in XML to Upload to EudraCT, or
ClinicalTrials.gov
The remit of the European Clinical Trials Data Base
(EudraCT <https://eudract.ema.europa.eu/> ), or
ClinicalTrials.gov <https://clinicaltrials.gov/>, is to provide
open access to summaries of all registered clinical trial
results; thus aiming to prevent non-reporting of negative
results and provide open-access to results to inform future
research. The amount of information required and the format of
the results, however, imposes a large extra workload at the end
of studies on clinical trial units. In particular, the
adverse-event-reporting component requires entering: each
unique combination of treatment group and safety event; for
every such event above, a further 4 pieces of information (body
system, number of occurrences, number of subjects, number
exposed) for non-serious events, plus an extra three pieces of
data for serious adverse events (numbers of causally related
events, deaths, causally related deaths). This package prepares
the required statistics needed by EudraCT and formats them into
the precise requirements to directly upload an XML file into
the web portal, with no further data entry by hand.
