Study Configuration and Form Building
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      Host Level User Roles and Rights

      Configuring Host-Level Role Permissions

      TrialKit requires users to have a role at both the Host level and the Study level. The host level role is what determines user permissions for host level functions named in the list below.

      Table of Contents:

      Accessing Host-Level Permissions

      Prerequisite for all functions covered in this article: User has access to host level Role Security permissions

      Host-level permissions are configured under the host menu as shown below.

      Web Browser:

      HostRightsManWeb

      Do not configure study roles (e.g. Monitor, Coordinator, Investigator) at the host level. Study-level roles are configured at the study level. 

      Most users at the Website Host level have a role of “No Access”. This simply means they have little or no access to host-level permissions described below. Instead, they will only have permissions at the study level.

      Host Level Permissions Index

      Host Level Permissions Table

      Application

      Permissions

      Definition

      Applicable Location

      Account Manager

      Grant Access to the account manager

      Gives access to host account information

      Account menu on the home screen

      Build Web Pages

      Grant access to building web pages

      This provides access to build web pages like Home, Contact Us pages

      Website Host>Host Web Page Builder

      CTMS

      Grant access to CTMS

      Gives the user access to the CTMS center

      The main navigation bar at the bottom of the iOS mobile app (coming soon to the web)

       

      CTMS Form Audit Reports

      Allows the user to access audit reports of user, site, and study forms

       

       

      Delete user form records    

      Allows the user to delete user form records from the CTMS. Note, this is separate from the permission to delete users from within the User Manager.

       

       

      Delete site form records    

      Allows the user to delete site form records from the CTMS. Note, this is separate from the permission to delete sites from within the Site Manager.

       

       

      Delete study form records    

      Allows the user to delete study-type forms from the CTMS. Note, this is separate from the permission to delete studies from within the Study Manager.

       

      Device Dictionary

      Grant Access to Device Dictionary

      Forms created in TrialKit can easily be made to display well on multiple device types and screen sizes. This gives form builders the most detailed control over form layout across the various devices that users of the study will be used for entering data.

      Ensure you have access to the Device Dictionary within the Host Configuration menu on the app. If you don't see it, contact support@trialkit.com to have it enabled.

      Electronic Trial Master File (eTMF)

      Grant Access to eTMF

      Provides access to the eTMF screen

      Trial Master File

       

      Add Folders

      Allows the user to add folders if they also have permission within the parent folder

       

       

      Upload Files

      Allows the user to upload files into a folder if they also have the folder permission to change it

       

       

      Delete Files or Folders

      Allows the user to delete any file or folder regardless of individual file/folder permissions

       

       

      Add/Change Properties

      Users can make permission changes to individual folders and files that they have view access to

       

       

      Full Access to All folders and files

      Overrides all individual folder/file permissions and gives full access to all folders and files.

       

       

      Lock Files

      Allows a user to lock files or folders that they have view access to

       

       

      Unlock Files

      Allows a user to unlock files or folders that they have view access to

       

       

      View Audit Report

      Gives user access to the complete TMF audit report. Note, this will display audit info for all folders and files even if the user does not have view access to those files directly.

       

       

      Copy Folders

      Allows the user to copy a folder along with its sub-folders

       

       

      Add/Remove Placeholder

      Users can create placeholders within folders they have access to

       

       

      View All Tasks

      All users can see their own tasks. This permission allows a user to see all tasks for all assignees.

       

       

      Assign Reviewers

      Users can assign reviewer users to any folder or file that they have access to.

       

       

      Review Status Report

      Users can access the TMF-wide document review audit history. This is separate from the other audited activities on the main audit report

       

      Form Builder

      Grant Access to Form Builder

      There are two form builders in TrialKit:

      • Host-level - Found under the Website Host menu

      • Study level - Found under the Study menu

      • THIS ONE IS THE HOST LEVEL

      Important: Most forms, like subject eCRFs, are built at the study level. Please ensure you are building your forms in the correct location and choosing the correct form type.

      Website Host>Host Web Page Builder>Host Form Builder

       

      Add New Form

      Allows the user access to create new forms on the Host Form Builder application. The right to save changes to forms (listed below as a separate right) is typically always granted along with this right. Otherwise, the user will be unable to save after creating a form.

      Website Host > Host Form Builder > 'Create New Form' link

       

      Select Existing Form

      Allows the user to select an existing form and view its attributes. The right to Save Changes to Form (listed below as a separate right) is typically granted with this right. Otherwise, the user can only view the form but not make changes.

      Website Host > Host Form Builder > 'Select Existing Form Name' link

       

      Save Changes to Form

      Allows the user to see the 'Save' button at the top right of the form builder workspace. This is necessary for a user to create new host forms or edit existing host-level forms.

      Website Host > Host Form Builder > 'SaveForm' button

       

      Import Form from Form Library

      Allows the user to access the form library and import a form into the existing HOST forms table to be used in the Host. Form libraries are created here under the Website Host menu, and make it possible to share forms between studies.

      Website Host > Host Form Builder > 'Import Form' link

       

      Export Form to Form Library

      Allows the user to export a form into a form library. Form libraries are created under the Website Host menu, and make it possible to share forms between studies.

      Website Host > Host Form Builder > 'Export' link in each row of the Existing Forms table

       

      Delete Form

      Allows the user to delete individual forms from the Existing Host Forms table.

      Website Host > Host Form Builder > 'Delete' link in each row of the Existing Forms table

      Form Library Manager

      Grant Access to Form Library Manager

      Form libraries are created under the Website Host menu, and make it possible to share forms between studies.

      Website Host > Form Library Manager >

       

      Edit Form Library

      Allows Administrators to Edit Form Library Name

      Website Host > Form Library Manager >  Edit Link at end of each library row

       

      Add Form Library

      Allows Administrators to Add Form Library Name

      Website Host > Form Library Manager > Add name Link

       

      Delete Form Library

      Allows Administrators to Delete Form Library

      Website Host > Form Library Manager > Delete Link at end of each library row

      Host Administration Tools

      Configure Reporting Objects and Study Notifications

      Allows Access to configure reports, study-specific user notifications, and sign in audit report

      Host menu > Reporting Objects, Study notifications, and Sign In audit report

      Host Copy Study

      Grant Access to Host Copy Study

      This application allows you to copy studies between Website Hosts. In order to copy a study from a host or to another host, you must have been granted the right to Copy From the Website Host and/or Copy to the Website Host

      Website Host > Host Copy Study >

       

      Copy from Website Host

       Host and Study to copy from

      Website Host > Host Copy Study > drop-down ‘Copy From’

       

      Copy to Website Host

       Host to copy the study to

      Website Host > Host Copy Study > drop-down ‘Copy To’

      Lab Range Manager

      Grant Access to Lab Range Manager

      This provides access to the Lab Range Manager used to build the forms which will be used in the study.

      Website Host > Local Labs and Ranges >

       

      Edit Existing Lab

       Edit an existing lab in the host

      Website Host > Local Labs and Ranges >

       

      Add New Lab

       To add a new lab

      Website Host > Local Labs and Ranges > Enter the lab information and click the Save Lab button.

       

      Delete Existing Lab

       Delete an existing lab in the host

      Website Host > Local Labs and Ranges >

      Pages Granted to all Users

      Access Pages Granted to all Users

      This application allows you to grant all users full access to all forms at the current level.

      Website Host > Grant All Users Full Access to All Forms>

      Role Security

      Grant Access to Role Security

       

      Website Host > Role Manager >

       

      Add New Role

      Allows users to add new roles to the Add/Edit Roles section of Role Security.

      Website Host > Role Manager > 'Add New Role' area. Enter the role description/ hierarchy in the host and click the Save Role button.

       

      Edit Existing Role

      Allows users to Edit existing study roles in the Add/Edit Roles section of Role Security.

      Website Host > Role Manager > 'Edit' link in each row of the Existing Roles table

       

      Delete Existing Role

      Allows users to delete existing study roles in the Add/Edit Roles section of Role Security.

      Website Host > Role Manager > 'Delete' link in each row of the Existing Roles table

       

      Grant rights to my role that have not been granted

       

      Website Host > Role Manager >

       

      Grant Form Right

      Allows users to set the role rights on each form in the Host.

      Website Host > Role Manager > 'Form Rights' link in each row of the Existing Roles table

       

      Blind Fields

      Allows users to blind roles to specific fields on each form.

      Website Host > Role Manager > 'Blind' link in each row of the Existing Roles table

      Site Manager

      Grant Access to the Site Manager

       

      Website Host > Site Manager >

       

      Add New Site

      To add a new site, enter the user information and click the Save Site button.

      Website Host > Site Manager > Add new site

       

      Edit Existing Site

      To edit an existing site, click the edit link.

      Website Host > Site Manager > 'Edit' link in each row of the existing sites table

       

      Delete Site

      To delete an existing site, click the delete link.

      Website Host > Site Manager > 'Delete' link in each row of the existing sites table

      Site/User Audit Report

      Run and View Report

      Shows all transactions for sites and Users that have been added, updated, or removed from the study.

      Website Host > Site/User Audit Report>

      Study Manager

      Grant Access to the Study Manager

       

      Website Host > Study Manager >

       

      Add New Study

      To add a new study enter the study information and click the Save Study button.

      Website Host > Study Manager > Add a new study section below the table of existing studies.

       

      Edit Existing Study

      To edit an existing study, click the edit link.

      Website Host > Study Manager > 'Edit' link in each row of the existing studies table

       

      Delete Study

      To delete an existing study, click the delete link.

      Website Host > Study Manager > 'Delete' link in each row of the existing studies table

       

      Archive Study

      To archive, an existing study, click the ‘Click here to archive’ link to change to archived and vice versa.

      Website Host > Study Manager > 'Click here to archive' link in each row of the existing studies table

      Theme Manager

      Grant Access to Host Theme Manager

      Contains the image files that are uploaded or a sample starting theme is installed that can be updated/edited.

      Website Host > Host Theme Manager >

      User Manager

      Grant Access to User Manager

       

      Website Host > User Manager >

       

      Add User

      To add a new user enter the user information and click the Save User button.

      Website Host > User Manager > Add new user section below current user listing table

       

      Edit User

      To edit an existing user, click the edit link.

      Website Host > User Manager > 'Edit' link in each row of the existing user's table

       

      Delete User

      To delete an existing user, click the delete link.

      Website Host > User Manager > 'Delete' link in each row of the existing user's table

       

      Suspend User

      To suspend an existing user, click the activated link to change to suspended and vice versa.

      Website Host > User Manager > 'Status' link in each row of the existing user's table

       

      Host-Level Form Permissions

      Similar to the study level, host-level forms are able to be configured with view/edit permissions by role.

      Those permissions are accessed within the Host Role Manager as shown below.

      Grant Rights To All Forms For All Users

      This alleviates the need to individually give permissions to the various roles. Particularly helpful if several new forms have been created and all roles need access.

      Host-Level Field Blinding

      Also, similar to study form field blinding, host forms can have fields blinded based on the user's host-level role.

      This is accessible within the Role Manager as shown below.