Settings

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 general settings (see below), and there may also be some trial-specific settings. 

Additionally, on this page you can also access the feature to edit user permissions if this is supported in your system.

General settings

Review step

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 article.

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.

Investigator edit

The Investigator edit setting is turned on by default. 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.

Subject delete

The ability to delete participants is turned off by default. Deleting a participant 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 participants because all randomised participants must be accounted for.

If a participant was randomised in error, mark them as such rather than deleting the record.

Form delete

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 participant must be deleted to remove this form.

Randomisation

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 because of 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.

Ensure all groups available at site

When this setting is on, randomisation is allowed only if kits for all treatment groups are available at a participant's site. This setting only applies to double blind trials. If the setting is off, then the participant may be randomised without a kit code.

User permissions

A user with an administrator or designer role can edit the privileges available to each role and create/delete new roles to fit the trial requirements. You can access the editing feature via the Settings or Specification pages.