Database lock and close down process

Database lock

Depending on the software version of your app, there are a number of options open to you to implement a database lock.

Red Pill version 25 and earlier

You have several options:

1. Turn off randomisation and the 'investigator edit' privilege on the settings page. Investigators will still be able to add forms to existing patients and use queries to request edits to existing data.
2. Suspend investigator roles to prevent all changes. You can use a read-only role such as Monitor if you want investigators to continue to be able to see data.
3. Submit a change request to customise the privileges available to particular user accounts; such as adding forms, editing forms, raising queries, and so on.

Red Pill version 26 and later

Turn off randomisation and edit user permissions on the Specifications page. You can remove certain privileges from user roles as required; such as adding forms, editing forms, raising queries, and so on.

Code break

If you have a blinded randomisation system you can download an archive for the statistician to use to break the blind. The archive will contain the unblinded treatment groups in the data for the randomisation form, as well as the unblinded code list.

Close down process

We require 30 days notice of termination to close down your system. Once you give us notice, we will send you a close down form and give you a provisional close down date (i.e. date of notice + 30 days).

You can use an archivist account to download all the data and audit log. An administrator can create this account in the same way as for other roles.

Once you've downloaded the data and checked it, please return the close down form to give us permission to delete the database and all data from our servers.

Please return the signed close down form before the provisional close down date.