User Management

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Last updated: Apr 23, 2022 by TK Support
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The User Manager is the first stop and the first step (out of two) for adding users to a study. This is where users are globally managed for a given Host Account. Access to the User Manager is based on role permissions. Typically this is a Host Administrator, but can be granted to other roles as needed.

An important concept to understand is that every user has access at two separate levels. In other words, they have roles at both the:

  • Host Account level; and

  • Study level

This method of organization allows Account Administrators to add users at the website host level, and then make them part of one or multiple studies under that “host” account without needing to add the users repeatedly.

Use the links here to read about adding or managing users at the two levels:

 

Adding Users at the Host level

After opening the User Manager from the Website Host menu, the following describes the various functions that can be performed on users for a given host account, on both website and mobile application.

A necessary and first step to providing someone access to a study is to first provide them access to your host/account where all users are centrally managed across all studies within that host.

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

On the web:

 

On the Mobile App:

 

The form to add a new user is found via the Add New User button:

 

Fill in the fields. Verify the email address entered is correct. This can always be updated later for the user.

 

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.

Read here on how to add users to specific sites and assign study roles.

 

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.

On the web, this attribute is accessed in the user details:

 

On the app, tap on any user to open the details:

 

 

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 also manually designating them to specific sites.

From the mobile app:

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:

  • Column 1: User first name

  • Column 2: User last name

  • Column 3: User email address

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

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

  • 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:

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

 

  1. Be able to filter to search for specific users or groups of users.

  2. Table 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. 

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.

 

  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:

  1. User name and email

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

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

  4. Enable which studies the user will have access to. This will make the user available to assign to a site when managing the study level access.

 

Adding/Managing users at the study level

 

On the web

  1. Under Study Configuration settings, select the Sites & Users tab

  2. 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.

On the 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.

 

  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 Manger. 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.

 

Site/User Audit

The Site/User Audit tracks all changes with regard to the activities performed on User access

Sign In Audit

The sign-in audit is a host-level report that tracks user sign-ins to any study within the current host. It logs the following details:

  • Date/time

  • User

  • Study

  • Platform

  • IP address

It can be accessed from the User Manager screen on the web, based on permission to host-level Reporting objects On the app, it's found under the host menu.

 

 

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