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.
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.