Creates Safety Results Summary in XML to Upload to EudraCT, or ClinicalTrials.gov
internal function to append rows to the output xml file
applies a conversion using xslt from a simple xml file to a ClinicalTr...
applies a conversion using xslt from a simple xml file to a ClinicalTr...
function that creates a safety_summary object from individual data.fra...
function to make a data frame be entirely character vectors
creates a dot-plot of safety data showing the absolute and relative ri...
applies a conversion using xslt from a simple xml file to a eudract co...
provide standard structured tables to report incidence rates of AEs by...
plot methods for dot_plot object
print methods for dot_plot object
print method for safety summary object
Calculate relative risks to be reported or plotted as dot plot
Calculate frequency tables from a rectangular data frame with one row ...
creates a simple xml file from the input of a safety_summary object
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.