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  2. Study Configuration and Form Building

Host Level User Roles and Rights

Creating Users at the Website Host Level

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.

If you are accessing any item from the Host menu shown, it's because of your role and rights at the Host level.

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:

Host Level Permissions Table

Application

Permissions

Definition

Applicable Location

Account Manager

Grant Access to account manager

Gives access to host account information

Account menu on the home screen

Build Web Pages

Grant access to build web page

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

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

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 using 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 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