Archives

Users with the archivist role are able to download an archive containing all application data.

The archivist role may be useful, for instance, to allow a statistician to download data required for interim analyses for Data Monitoring Committee meetings. It may also be used at the end of trial during close-out.

Archives may include sensitive data such as randomisation lists and unblinded data. For this reason, the archivist role should not normally be assigned to any staff involved in the day-to-day running of the study. The fact an archive was downloaded is recorded in the application audit trail.

Button to download an archive of all data for a trial

Archive contents

Users with the archivist role will see a button to download the archive. The archive is a zip file containing:

  • README.txt with a description of the archive contents and MD5 checksums for each file in the archive
  • Complete MySQL dump file for the study database
  • Comma separated value (CSV) files for all forms in the CRF and other datasets such as randomisation and code lists
  • Stata files for all forms in the CRF and other datasets such as randomisation and code lists
  • A data dictionary showing the structure of every form in the database. Additional information on each column shows the question as it appeared in the CRF or randomisation form.
  • Copy of the final audit log. This text file contains a timestamped record of every action that created, updated or edited data. Each action is linked to the relevant user account.
  • Log of user account actions. This text file contains a timestamped record of every action that created or updated a user account, role or notification account linked to the system and the user account that performed each action.
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