Users with the archivist role are able to download an archive containing all application data.
Archivist user accounts cannot be created by administrators and must be requested by contacting Sealed Envelope. The archivist role may be useful, for instance, by 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.
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
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.