Introduction

This is the home page of a NIHR-funded project to provide tools that will prepare the required statistics needed by EudraCT and format them into the precise requirements to directly upload an XML file into the web portal, with no further data entry by hand. This tool was developed by Cambridge CTU, in collaboration with Birmingham, Glasgow, Leeds CTUs.

The remit of the European Clinical Trials Data Base (EudraCT) is to provide open access to summaries of all registered clinical trial results to help prevent non-reporting of negative results and inform future research. The amount of information required and the format of the results, however, imposes a large extra workload on Clinical Trial Units at the end of studies. In particular, the adverse-event-reporting component requires entering each unique combination of treatment group and safety event along with varied amounts of additional data, depending the severity of each event.

Flow-Chart

An overview of the components to the tool is shown below.

flowchart

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