Understand what the SMART-TRIAL Study Permissions mean
By default, all permissions are not enabled when adding a collaborator to your study. Make sure to review the permissions before proceeding.
Can add and remove collaborators, and change their permissions
Can view and search in the study wide audit log
Can setup, test, and delete Study Notifications. You can create "listeners" for certain actions in a study and specify who should be emailed or which end point should be called.
Can view and renew the study API key
Can create/edit/delete: Questions/forms/processes/sites, amend/start/stop the study and start/stop testmode, and duplicate study. The one permission needed to setup the study.
Can see the statistics in the sites overview and population data in the Data menu
Export Randomization list
Can export randomization list.
Roles have certain permissions associated with them, and by selecting a role these permissions automatically get selected.
It is possible to add or remove permissions after a role has been selected, this will change the role to “User Defined”, however, this combination of permissions are NOT saved as a role. It is NOT possible to create custom roles at the moment. We modeled the roles after clinical studies, why they might not exactly fit every type of study conducted in SMART-TRIAL, please keep that in mind. If you feel one or more of the roles are completely off or if you have ideas for additional roles, you can write us at firstname.lastname@example.org
Study level permissions have to be chosen manually and do not relate to any site role.
Description of site permissions
Allows the user to see the site overview and subject progress on said site (data events and unscheduled events). NO data can be seen. This permission is also given with many other permissions, but having it as its own allows for users to see the progress of a site but do nothing else.
Can enroll, update/edit, and discontinue subjects. Regardless of 'View Identifiable' this permission allows the user to create subjects.
Is allowed to view identifiable information such as Name, Phone number, and addresses. If this permission is not given, the user will only be able to see a subject ID or a SMART-TRIAL internal ID.
Allows the user to view ALL data for the specific site: Form answers, (S)AE’s, unscheduled events, medication, and subject profiles and changelogs.
Allows the user to activate data events, fill out forms, edit form data, add comments, and respond to queries.
Allows the user to remove and restore (S)AE’s, medication, and unscheduled events. Remove, removes the item from the regular study and the export. Removed items are put into ‘storage’ from where they can be restored.
Allows the user to start the randomization event and press ‘randomize’.
Allows the user to see the allocation group (both randomization group and trial group attribute, depending on which is used).
Allows the user to unblind themselves and view the allocation group of a specific subject.
Can create, view, fill in, and edit unscheduled events.
Can enter and edit medication + medication accounting.
Can view (S)AE’, fill, and edit general information in (S)AE’s.
Receives notifications about SAE’s, can view AE’s, fill in investigator restricted fields, and sign the report.
Receives notifications about SAE’s, can view AE’s, fill in sponsor restricted fields and sponsor sign the report.
Can view and can edit an (S)AE after it has been signed the final time. Will require a reason for change and change is visible in the changelog.
Users can view, create, open and close queries.
Can lock and unlock data events.
Can archive and unarchive subjects.
Can sign off enrollments, one at a time.
Can export all data for the specific site.
If the user does not have view identifiable information, subject attributes associated here, cannot be exported.
Can verify and unverify data elements.
Can verify and unverify data elements.
Allows users with the permission to change or set the activation time of a data event.
Manage Subject App
Allows the user to revoke access and resend authentication code for specific subjects in studies using the Subject API.
If a study collaborator is unable to view certain things or perform a certain action, it is most often due to a lack of permissions. Please double-check the permissions before contacting support.