eudract v0.9.0

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Creates Safety Results Summary in XML to Upload to EudraCT

The remit of the European Clinical Trials Data Base (EudraCT <https://eudract.ema.europa.eu/> ) 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.

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eudract

The goal of eudract is to provide tools to easily produce summaries of safety data from clinical trials that can easily be uploaded into eudraCT.

Installation

You can install from CRAN directly with

install.packages("eudract")

You can install the very latest version on github with:

install.packages("devtools")
devtools::install_github("shug0131/eudraCT/R/eudract")

Documentation

https://eudract-tool.medschl.cam.ac.uk provides full documentation

Go and read the help pages within R

?eudract::safety_summary
#> starting httpd help server ... done

Functions in eudract

Name Description
print.safety_summary print method for safety summary object
eudract_convert applies a conversion using xslt from a simple xml file to a eudract compatible file, and checks against the schema
soc_code System Organ Class coding
append_xml internal function to append rows to the output xml file
simple_safety_xml creates a simple xml file from the input of a safety_summary object
create.safety_summary function that creates a safety_summary object from individual data.frames
safety_summary Calculate frequency tables from a rectangular data frame with one row per subject-event
safety Example of safety data
df_to_char function to make a data frame be entirely character vectors
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Vignettes of eudract

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eudract.Rmd
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Details

Type Package
Date 2019-11-06
URL https://eudract-tool.medschl.cam.ac.uk/
BugReports https://github.com/shug0131/eudraCT/issues
License GPL-2
Language en-GB
Encoding UTF-8
LazyData true
RoxygenNote 6.1.1
VignetteBuilder knitr
NeedsCompilation no
Packaged 2019-11-06 15:43:05 UTC; sjb277
Repository CRAN
Date/Publication 2019-11-07 10:10:08 UTC

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