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.
Brief Overview
Study Permissions
Manage Collaborators (In depth)
Can add and remove collaborators, and change their permissions.
Audit log
Can view and search in the study wide audit log.
Identifiable subject attributes can only be seen if the user also has "View Identifiable".
Study Notifications
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.
API
Can view and renew the study API key
Setup Study
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.
Statistics
Can see the statistics in the sites overview and population data in the Data menu
Export Randomization list
Can export randomization list.
Site Permissions
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 support@smart-trial.com
Study level permissions have to be chosen manually and do not relate to any site role.
Roles
Download permission roles table
Description of site permissions
Site progress
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.
Subjects
Can enroll, update/edit, and discontinue subjects. Regardless of 'View Identifiable' this permission allows the user to create subjects.
View Identifiable
Allows the collaborator to view identifiable subject attributes such as Name, email address, and phone number.
View Data
Allows the user to view ALL data for the specific site: Form answers, (S)AE’s, unscheduled events, medication, and subject profiles and changelogs.
Enter/Edit
Allows the user to activate data events, fill out forms, edit form data, add comments, and respond to queries.
Remove
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.
Randomize
Allows the user to start the randomization event and press ‘randomize’.
View randomize
Allows the user to see the allocation group (both randomization group and trial group attribute, depending on which is used).
Emergency Unblind
Allows the user to unblind themselves and view the allocation group of a specific subject.
Unscheduled
Can create, view, fill in, and edit unscheduled events.
Medication
Can enter and edit medication + medication accounting.
Report AE
Can view (S)AE’, fill, and edit general information in (S)AE’s.
Investigator AE
Receives notifications about SAE’s, can view AE’s, fill in investigator restricted fields, and sign the report.
Sponsor AE
Receives notifications about SAE’s, can view AE’s, fill in sponsor restricted fields and sponsor sign the report.
Amend (S)AEs
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.
Query
Users can view, create, open and close queries.
Lock
Can lock and unlock data events.
Archive
Can archive and unarchive subjects.
Sign off
Can sign off enrollments, one at a time.
Export
Can export all data for the specific site.
If the user does not have view identifiable information, subject attributes associated here, cannot be exported.
Verify I
Can verify and unverify data elements.
Verify II
Can verify and unverify data elements.
Reschedule (In depth)
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.
In depth overview (Work in Progress)
In this section each permissions is explained in more detail, with an example to clarify how they work.
Study Permissions
Manage Collaborators
Can add and remove collaborators, and change their permissions. The study owner will always have this permission, but it is recommend to give at least one other collaborator this permission as well. To ensure new site personnel can be added, or permissions updated, in case the study owner is unavailable.
Audit log
Can view and search in the study wide audit log. Only give this permission to users who are allowed to see ALL study data, as everything will be available in the audit log.
Identifiable subject attributes can only be seen if the user also has "View Identifiable" on the site where the subject is.
Study Notifications
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.
API
Can view and renew the study API key.
Setup Study
Can create/edit/delete: Questions/forms/processes/sites, amend/start/stop the study and start/stop test mode, and duplicate study. The one and only permission needed to setup the study.
Statistics
Can see the statistics in the sites overview and population data in the Data menu, for the sites they have access to.
E.g. if there are 20 subjects in the study, 10 on site A, and 10 on site B.
If the collaborator have access to site A, they will only see statistics for site A in the overview. If they have access to both sites, they will see combined data.
Export Randomization list
Can export randomization lists from the study, which can be sent to pharmacies allowing them to pack medication for a blinded trial. Should only be given to unblinded study collaborators.
Site Permissions
Site progress
Allows the user to see the site overview and subject progress on said site (data events and unscheduled events). NO actual 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.
Subjects
Can enroll, update/edit, and discontinue subjects. Regardless of 'View Identifiable' this permission allows the user to create subjects and enter all the required identifiable information.
View Identifiable
Without this permission the collaborator will only be able to see the following subject attributes:
Subject ID
Birth year
Trial group (not related to randomization)
Any other collected attribute will be redacted with ******.
This permission must be selected if you wish to include identifiable subject attributes in the export.
View Data
Allows the user to view ALL data for the specific site: Form answers, (S)AE’s, unscheduled events, medication, and subject profiles and changelogs.
Enter/Edit
Allows the user to activate data events, fill out forms, edit form data, add comments, and respond to queries. User with this permission will also get in-app notifications when queries are created, they can respond to.
Remove
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.
Randomize
Allows the user to start the randomization event and press ‘randomize’, to assign an enrollment to an allocation group. Required for any user who should initiate randomization.
View randomize
Allows the user to see the allocation group (both randomization group and trial group attribute, depending on which is used). Only give this permission to UNblinded study personnel
Emergency Unblind
Allows the user to unblind themselves and view the allocation group of a specific subject. The blind can be broken as many times as required, and is audit logged.
Unscheduled
Can create, view, fill in, and unscheduled events. Give to collaborators who should be able to create unscheduled events.
Medication
Can enter and edit medication + medication accounting.
Report AE
Can view, fill, and edit general information in (S)AE’s.
Investigator AE
Receives notifications about (S)AE’s, can view AE’s, fill in investigator restricted fields, and sign the report.
Sponsor AE
Receives notifications about SAE’s, can view AE’s, fill in sponsor restricted fields and sponsor sign the report.
Amend (S)AEs
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.
Query
Users can view, create, open and close queries.
Lock
Can lock and unlock data events.
Archive
Can archive and unarchive subjects.
A boolean (True/False) that can be included in the export. Has not effect within SMART-TRIAL.
Can for instance be used to differentiate between subjects that are ready for data collection i.e. all queries resolved, all data cleaned. In the export file these would be marked with "Yes" in the "Archived" column.
Sign off
Can sign off enrollments, one at a time.
Usually given to Investigators, allowing them to sign the enrollment at the end of the study. Signing off will also lock all data events. Unlocking a data event afterwards, will remove the signature, and the enrollment will have to be signed off again.
Export
Can export all data for the specific site.
If the user does not have view identifiable information, subject attributes associated here, cannot be exported.
Verify I
Can verify and unverify data elements with verification 1. Which includes: Medication, AE reports, and question answers.
Verify II
Can verify and unverify data elements with verification 2. Which includes: Medication, AE reports, and question answers.
Reschedule
Manage Subject App
Allows the user to revoke access and resend authentication code for specific subjects in studies using the Subject API.