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      Collaborator Permissions

      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

       Click the image to see a larger version.

      PermissionImg

      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

      Reschedule allows you to move the activation date of a data event. You also get to select if that move should be applied only to the selected data event, OR if all the later data events should be updated as well.
      An example:
      If you have a process with 4 data events, where data event 2,3, and 4 use the activation "on previous start" with a 7 day delay. Such that once DE1 has been started, DE2 will be scheduled 7 days later, DE3, 7 days after DE2, and DE4 7 days after DE3.
      If we pretend DE1 was started on the 1st of September, the rest of the data events would have the following activation dates:
      DE2: 7th
      DE3: 14th
      DE4: 21st
      You can then reschedule DE2 to the 6th of September or the 9th, in case the subject cannot come in on the 7th or does not want to receive an email on that day.
      If you change it to the 6th, you get the options of leaving the rest of the activation dates, for DE3 and DE4 the same as they are resulting in:
      DE2: 6th
      DE3: 14th
      DE4: 21st
      This option is good if it is only the one data event that cannot quite fit into the scheduled program.
      OR you can select that the system should move those the same amount of days, as you moved DE2.
      If you select that option, it would result in the following activation dates:
      DE2: 6th
      DE3: 13th
      DE4: 20th
      Reschedule is strictly about activating data events, which will happen regardless of validation rules. The validation rules will check if the entered dates (e.g. date of visit) still adhere to the rule. But the validation rule will not be changed or affected by a data event reschedule.
      This is particularly useful in studies with a lot of automated send out, where the study may run into a delay or in case a patient would like to receive emails at a different time. As you can also change the time of day they receive emails.

      Manage Subject App

      Allows the user to revoke access and resend authentication code for specific subjects in studies using the Subject API.