Summary

Overall ClinSpark User permissions are managed within the User Profile and cover 3 levels:

• A Role/Roles are to be assigned to User(s)

• In case of a multi-site customer, users can be restricted to certain Sites only

• Users can be restricted to certain Studies only

Default Settings

New users will have no assigned Roles. To be able to log into ClinSpark, users need at least one Role assigned to their User Profile. Their User Role will allow them to perform the assigned Role Actions within ClinSpark.

A newly created User will have no Study and Site restrictions applied. There are two approaches you can take in managing default user access to Studies and Sites.

• Allow access to all Studies and Sites by default

• Do not allow access to any Studies nor Sites by default

This can be controlled with the “Require restrictions” settings in the User Profile:

When the “Require restrictions” settings are enabled for the User, they will have no Study nor Site access by default. You will need to explicitly add Studies and Sites that the User should be able to access.

When the “Require restrictions” settings are disabled for the User, they will have access to all Studies and Sites by default, unless you restrict access to specific Studies and Sites (via User Profile or Study > Configure > User Access).

Manage User Access to specific Sites

You can use the “Restricted Sites” section in a User Profile to manage user access to Sites.

If the “Require Site Restrictions” setting is disabled for the User, leaving the “Restricted Sites” section blank will give the User access to all Sites. Is the “Require Site Restrictions” setting is enabled for the User, you must add at least one Site that the User should have access to.

To manage User Access per Site:

1. To allow User access using the User Profile settings, go to Administration > Users, search for the desired User and click on their name to access their User Profile.

2. In the “Sites” section, click the green “Add” button.

3. Select the desired Site from the dropdown and tick the “Recruitment Restriction?” tickbox for User who will only perform recruitment-related actions within the Site.

4. Click “Save” to continue.

5. Repeat this for each Site that the User should have access to.

Manage User Access to Studies

To manage User Access to Studies, you can user their User Profile settings or a study specific User Access module (Study > Configure > User Access).

If the “Require Study Restrictions” setting is disabled for the User, leaving the “Restricted Studies” section blank will give the User access to all Studies. If the “Require Study Restrictions” setting is enabled for the User, you will need to add Studies that the User should have access to.

Using the User Profile settings to restrict access

This is the most common method for restricting users to specific studies.

1. To restrict User access using the User Profile settings, go to Administration > Users, search for the desired User and click on their name to access their User Profile.

2. In the “Restricted Studies” section, click the green “Add” button.

3. Select the desired Study from the dropdown and click “Save” to continue.

4. Repeat this for each Study that the User should have access to.

Using the Study Specific Controls to restrict access

For customers that need to be able to control User permissions on a per-Study level, there is a feature in Study > Configure > User Access to support this need. This Study specific User access layer works cumulative to the overall user permissions defined in the User Profile, but the study specific settings take priority. Note that this feature set is opt-in per study.

1. 

   To restrict User access using the Study Configure module, select the desired Study in the Study selection dropdown at the top of the page.

2. Navigate to Study > Configure > User Access section.

3. Click on the “Action” menu and select “Import”. The “Import Study Users” screen will open.

   

4. Search for Users by applying the “Site” and “Role” filters. If a User has multiple Roles, but they had only been trained for some of them for this specific Study, apply the “Role(s)” filter and only add them for each specific Role that they had already been trained for. You can add other Roles for the User later on.

   

5. Select the “Users Active” tickbox to mark them as active on the Study immediately. Leave the tickbox unchecked, if you wish to “activate” them later.

   

6. Select all of the Users who are authorized to access the Study information from the list, by ticking the appropriate tickboxes.

   

7. Click “Save”. Users list will be populated in the “User Access” section. Please note how in this example, the User Roles are Data Collector and QC Nurse, but they had only been added to this Study as “Data Collector”:

   

You can later on modify User Access using the Action menu:

• Import additional Users

• Activate/Deactivate selected Users

• Add/Remove Roles for selected Users

• Delete Users added in error

User Access Hierarchy

Study specific settings will always take priority over the User Profile Settings. This means:

1. User has access to a Study in their User Profile, but they are not added to the list of authorized users in the Study Configure module = User will not have access to the Study.

2. User has access to Study A in their User Profile (no additional restrictions are defined in Study Configure) and access to Study B on the Study Configure module = User will have access to Studies A and B.