User accounts and roles

1. Sealed Envelope help
2. Access
3. User accounts and roles

For a trial

User accounts and roles for a specific trial can be viewed by administrators with the ‘Users’ link in the trial panel.

Roles in italics are suspended. New accounts can be created using the ‘Create a new user’ button. Clicking on a name in the list shows details about that account including name, email address, date of last log in and password change. The user’s password can be reset using the ‘Reset password’ button on this page. This sends a new password to the user’s email address.

The name and email address can be updated by editing the user account.

All users

User accounts across all trials that a user administers can be viewed by clicking the ‘Users’ link in the navigation bar at the top of the screen.

Clicking on a user’s name shows all the user’s roles. Roles in trials which are administered by the logged in user are clickable and show more detail on roles.

Assigning a user to a new role will send them an email to inform them of their additional role.

A role can be edited to change the site, status (active or suspended) and to enable or disable notifications.

Roles and privileges

Each trial has several roles with different privileges. The roles and privileges will vary by trial. However the following roles are normally available:

Superuser

Has access to all trials and all features. Reserved for Sealed Envelope staff only.

Administrator

Has access to selected trials, but usually all features within those trials. Intended for use by trial managers and other staff at the trial co-ordinating centre.

Investigator

Has limited access to selected trials. Investigator accounts are linked to a particular trial site and only subject data or randomisations from that site may be viewed. Investigators have no access to administrative functions (such as reports, sites, user accounts and log sections).

Notification

Used for notifications only - this account cannot log in to the system. May, optionally if enabled, be used to send notifications to fax recipients.

Some trials may have the following account types:

Statistician

Read only access to subject data and ability to download for analysis.

Monitor

Read only access to subject data and ability to create or respond to queries.

Archivist

Download an archive containing all application data. This role can only be assigned by Sealed Envelope on request.

Warning archives may contain sensitive data such as randomisation lists and unblinded data. Think carefully about the risks before assigning this role to anyone involved in the day-to-day running of the study.

Randomisation systems may also have the following account types:

Randomisation

Limited account that can only randomise and view previous randomisations for a particular site.

Unblinding

Limited account that can only unblind treatment and view previous randomisations for a particular site.

The privileges available to each account type are fine tuned by the configuration for a particular trial - for instance investigators may or may not be allowed to unblind treatment. The actual privileges available are shown on the account creation screen.