A settings page is available to administrators that allows some features to be turned on or off to suit the requirements of a trial. Changes to settings are recorded in the audit trail. There are some common settings (see below) and there may also be 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, administrators 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 data entry staff are entering paper CRFs into a Red Pill database.
Note the review step is always enabled for randomisation forms
By default investigators cannot edit forms - only add them and view them. This setting enables investigators to also edit forms after they have been saved. In addition it allows investigators to mark forms in a visit as missing.
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. Administrators 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.
Allows an administrator to delete forms. The deleted data is shown in the audit trail. Randomisation forms cannot be deleted - the randomised in error feature should be used instead. Study entry forms may not be deleted either - the subject must be deleted to remove this form.
The form delete setting will not be shown for randomisation only systems
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.
Randomisation is allowed only if kits for all treatment groups are available at a subject’s site. This setting only applies to double blind trials. If the setting is off, then the subject may be randomised without a kit code.