A settings page is available to administrators that allows some features to be turned on or off to suit the requirements of your trial. Changes to settings are recorded in the audit trail. There are some common settings (see below) and you may also have some trial specific settings.
The review step is turned on by default and introduces an intermediate step when saving forms. The user is required to review the form data and enter their password to confirm the information is correct before the data is saved to the database. The process is described in the data entry section. Since investigator accounts normally do not have privileges to enter data once it is saved, the review step can help to prevent errors which would then require a query to resolve.
However, you may prefer to turn this review step off. In this case the form is saved immediately with no intermediate review page. This could be preferable, for instance, if you have data entry staff entering paper CRFs into a Red Pill database.
Note the review step is always enabled for randomisation forms
The ability to delete subjects is turned off by default. Deleting a subject will also remove all their CRF data, randomisation data and queries. The deleted data is shown in the audit trail but the action cannot be undone. You should consider very carefully whether to turn this feature on and use it. We recommend it is used only in exceptional circumstances.
We strongly discourage using the delete feature on randomised subjects because all randomised subjects must be accounted for.
If a subject was randomised in error mark them as such rather than deleting the record.
Randomisation systems and Red Pill systems with a randomisation form can turn randomisation on or off. When randomisation is disabled, administrator accounts can still record manual randomisations. This may be useful, for instance, if offline randomisations have been carried out due to the Sealed Envelope website being unavailable.
This is a global setting - to stop randomisation at a specific site, edit the site and set Recruiting to No.