User Management

Adding and managing users within a host and its underlying studies

The User Manager is where users within a given host are centrally managed, regardless of which studies they belong to within the host account.

Every user has access at two separate levels:

  1. Host Account level - Add users here first.
  2. Study level - Add users here after adding them to the host.

Adding Users at the Host level

Prerequisite: User has access to Host level permissions for User Manager

Open the User Manager screen from the Host settings menu.

If the user is new to TrialKit, they can also be sent their sign-in credentials in this area.

Web Browser:

User Mgr1

Mobile App:

 User MgrApp
 The form to add a new user is found via the Add New User button:
 User MgrApp2
Fill in the fields for the form presented.
Additional information about other properties available to set for users is available below.

Host Role

The role selected is the Host level role, not the study role. The user's site and study role are managed separately.

Most users at the site level will have the role of 'No Access'

 
Once a user is added to the list, it can be opened up with further options to include study access and sending login info.  

TMF User

Users who will use the Trial Master File (TMF) in any capacity should be given access here. This will make the user displayed as an option when assigning TMF tasks.

Web Browser: this attribute is accessed in the user details:

 TMF1
Mobile App: tap on any user to open the details:
 TMF2

Batch Uploading Users

A convenient way of adding users is available via the iOS app where a CSV formatted list of users can be uploaded all at once. Additionally, they can be immediately added to a study and site with a specified role in the same step. This is a big time saver over manually adding users one by one as described in the section above, and then having to manually designate each user to specific sites.

Mobile App:

 batch
This will open the device file manager to choose a CSV file for uploading. On an iOS device, that file must exist in the iCloud TrialKit app folder.

The file must be set up in the following way, with no column headers:

  1. Column 1: User first name

  2. Column 2: User last name

  3. Column 3: User email address

  4. Column 4 (optional): Study ID - The study ID to add the user to, found in the host Study Manager

  5. Column 5 (optional): Study role - The name of the study level role to give to the user

  6. Column 6 (optional): Site ID - This is the site to make the user a member of, with the role specified in the previous column

Important factors to note for batch importing users:

All users will be given a host-level role of No Access. Not all users need to have all six columns defined. The only required columns are the first three to add the users to the host.

Ensure duplicate emails are not used and the study role text matches the name of the role from the study configuration.

Please abide by TrialKit’s policy of only uploading user email addresses that are both valid and have given implied permission to be added within the system. This helps the system control spam and bounced email notifications to its users.

 

Managing Users at the Host level

Web Browser:
User4
  1. Ability to filter/search for specific email addresses, studies, and roles of users.
  2. User Manager Table functions:

Last Name: Last name of the user

First Name: First name of the user

Email: Email of the user

Role: Host-level role 

This is the Host-level role.  "No Access" merely means the user has no access to Host level functions.

Studies: Lists all studies the user is a part of. Users are added to studies here.

Status: By default when users are added, they are active. By selecting this link, users can be deactivated/suspended to remove the login access to the account without actually removing them from the account or studies. This is especially helpful for audit purposes. Rather than deleting users, they can be maintained in the list and simply denied future access.

User Profile: This is an optional form that can be customized here and filled out to collect specific data on individual users.

Send Sign-In Information: This is a link and a date of when the user last received login information. By selecting the link, the system will reset the user's password and send the user a notice. Users can also do this on their own by using the Forgot Password function.

Sign-in information and other system emails will come from the following email addresses/domains

  • webmaster@clsds.com
  • mobileadmin@trialkit.com

Be sure to add that address to the “safe sender” list in your organization's email system

Edit: Select this to edit the name, email, or role.

Delete: Select this to delete the user. This is not advised for users who have entered data in compliant studies, as it has the potential to remove that user's name from any audit trail or action they were historically involved in. Suspending users is the advised method.

 

Mobile App:

  1. Tap a row to edit the user's information. See the next image for more info.

  2. Tap the information icon to access any Host level user forms (study dependent)

  3. Search for users in the list

  4. Access more granular filters to apply to the list when searching for users

When a user is tapped, the following items can be edited:

 Edituserapp
  1. User's host-level role. Most users will be 'No Access' here because their role access is only at the study level.

  2. Functions to send the user login information or deactivate the user on the “host” account (all studies).

  3. Enable which studies the user will have access to. This will make the user available so site(s) can be assign to the user when managing the study level access.

Adding/Managing users at the study level

Prerequisite: User has access to Study Configuration, Configure Sites and Users

Web Browser:

Under Study Configuration settings, select the Sites and Users tab. Go through the following drop-downs to add users to appropriate sites with the appropriate study roles. 

  1. Site: Select which site to work with. The list of options here comes from the Site Manager. 
  2. User: Select which user to add. The list of options here comes from the User Manager.  The user email is included in the name drop-down to help distinguish who the user is.
  3. Role: Select the role to assign to the user. The list of options here comes from the Role Security settings. If only one option appears, it's because the user selected already belongs to another site with a specific role. Users can only have one role in a study.
  4. Add User to Site: Select this button to add the user to the list directly to the right.
  5. Save Study Configuration: Select this to save changes.

 config
 
Mobile App:

The mobile app makes managing users even easier, by allowing everything to be done from one place.

Under Study Configuration settings, select the Site/User Manager. Follow the annotated descriptions below the image.
config2

  1. Choose a role that new users will get. If a user is already part of one of the sites as another role, adding them to a new site will automatically change them to the new role that is set at the top of the screen. If you aren’t sure if a user is part of a site already and don’t want to tap through each site to find them, reference the site by user report.

  2. If a user is missing from the user's list, they can be added to the Host User List here without needing to navigate there to add them first.

  3. By default, the user list only shows users which have been made available to the study within the host User Manager. This makes user management easier to focus on only users applicable to the current study. If you don’t see a user in the list and want to make sure the full list of host users doesn’t already contain that user, then tap the box to display all of them. Users in red are not available for the study but can be by simply dragging them to a site.

  4. Use the search box over any of the lists to search that list (name or email).

  5. Drag any user in the list over to the site they need access to. Remember, Admin users only need to be added to one site if their role has permission to access all subjects.

  6. Tap a site to display the member users/roles at the bottom.

  7. Tap any user to change their current role. This will change their role on any sites they are part of.

Deleting a User 

To delete a user on the Mobile App, swipe from right to left on the user’s row in the bottom table.

Check out the following reports for viewing user site membership and audit logs of user or site membership changes over time:

  • Site By User Report
  • Sign In Audit
  • Site/User Audit