EUdraCT v7 preview
Posted by Andrew Smith on April 30, 2009
Version 7 of the EUdraCT database of clinical trials in the EU is expected to clear internal testing on June 1st 2009. User acceptance testing should take place from June 8th to 13th, in order to go live on June 18th.
At present, the database is designed for use by the Competent Authorities (CAs) throughout the EEA, with sponsor companies able to prepare study applications via a secure site, before making submissions to individual CAs by paper/CD-ROM. This basic purpose will not change in v7.
Among the functions of the new version are the inclusion of inspection data and automatic alerting to all CAs on refusal, interruption, conclusion or termination of a study. These were not discussed in depth at the meeting, with more focus on external functionality for sponsors.
The database currently provides sponsors with an online form to enter information about a study. This information is then saved to a local computer as an XML file, which populates the application form and is also sent to the CA for uploading to the database itself.
Important new functions that were demonstrated include the validation of the XML file, to ensure that all fields in the form have been completed appropriately. This validation will be performed using the ISO Schematron standard, and details of the rules will be published so companies can build prevalidation into their internal systems. To further aid validation, much more explanatory text will be added to the online forms, to aid completion. The validation report can also be saved as a PDF for inclusion with the application submission, and is tagged with the same identifier as the relevant version of the XML file. It will be possible to make a submission even if the validation check is not entirely passed, to permit novel types of study; in such cases, it will be obvious which fields are not validated, and these can be discussed in more detail between the sponsor and CA.
Another new function is the preparation of an application package, collating the raw XML file, the populated application form PDF and the PDF validation report in a single zip file, for writing to CDROM for inclusion with an application. All pages of each file are labelled with the XML identifier for version control. The files will be named to include the EUdraCT number for the study, the country being applied to and the date of preparation. One delegate highlighted that CAs have differing requirements for file names and structures on CDROM, but it was pointed out that the zipped files can easily be renamed, moved etc. accordingly.
The third major change in functionality enables users to compare two XML files (eg, two versions of the same application, applications for the same study to two CAs etc.) This provides a short summary which can be drilled through to see changes to individual data fields in a “tracked changes”-like format. In version 8, it will be possible to save this change report to a PDF file (although it can be simply printed out from v7 for temporary, informal analysis).
The final area of change in v7 will be an update to the terminology lists used to formalise usage throughout applications. In addition to updating MedDRA from v9 to its current version (v12), it will also include the EDQM lists of routes of administration and dosage, the ISO list of countries and the EudraVigilance list of active substances (eg, for comparators etc.) These will be updated monthly in v7, and dynamically linked in v8.
The following post will look further ahead to versions 8 and 9 of EUdraCT, which will enable study protocol information and results, respectively, to be made available to the general public.
