Study Role Permissions Guide

TrialKit AI

Grant Access

Allows access to TrialKit AI link for automatically importing PDF data into a study

Accessible through the Subject Manager, Link on right side of page

Action Item Report

Grant Access

This right will grant access to the Action Item Report in the Reports menu. If the user has a role responsible for a review level in the study workflow, they will see a list of records ready to be reviewed.

Reports > Action Item Report

Coordinator Action Items

For any role with this right, there is a section titled Research Data Coordinator in the Action Item Report. This is a list of missing records at a site, and records that have been flagged (data changed without a reason provided).

Reports > Action Item Report

DDE Clerk Action Items

Only needs to be granted to roles which serve as Double Data Entry users on a study which is set up as a DDE study.

Review Action Items

This displays the action items for every review level. Review levels are set up in the Workflow tab on the Study Configuration page. By default, each role will see their own action items that need review. However, if a particular role needs to be able to see the CRFs awaiting review at all review levels, this right must be selected.

Exclude Missing Records

Gives access to the function of excluding missing forms within the missing forms section of the action item report.

Action Item Report > Missing Scheduled Forms

Global Provide Reasons

Allows the user to provide a single reason for change to all records currently flagged for data changes and awaiting reasons.

Note, this will apply a reason to ALL records flagged in the study so should be used with caution.

Action Items Report > Data Changes Awaiting Reason

Adjudication

Grant Access

Allows access to form adjudication. Any role defined in the form builder as an adjudication level should have this permission. This function is only available on the TrialKit app.

Adjudication Report

Allows access to the adjudication report.

TrialKit app, Reports menu

Moderator Report

Allows access to adjudication moderator report.

TrialKit app, Reports menu

Configure Adjudication

Allows a Study Manager to assign users to events which need to be adjudicated.

TrialKit app, Study menu

Background Exports

Grant access to background export jobs

Adds option t

Build Web pages

Grant Access

This provides access to the Build Web Page application used to customize the page content. Note: To use the Build Web Page app, a custom theme must also be set up through the Theme Manager.

Website Host > Build Web Page

Dashboard Report

Grant Access

This provides access to the Dashboard Report application, which displays items such as the number of queries, CFRs, adverse events, records awaiting review, etc. This report only displays data on the sites which the user belongs to. Common study setup will allow all roles to have this right granted.

Reports > Dashboard Report

View Study Status

This right allows the user to view the study status section on the right side of the Study Configuration page. The user must also have the right to access Study Configuration. Viewing the study status is not necessary for most users. This is typically only a right given to an Administrator or similar role.

Study > Study Configuration

Change Study Status

This right allows the user to change the study status in the study status section on the right side of the Study Configuration page. The user must also have the right to access Study Configuration, typically only given to an Administrator or similar role.

Study > Study Configuration

Data Extraction

Grant Access to Data Exports

This right will give access to the Data Extraction menu and the ability to export data by form. Only Administrative roles can configure the By Form exports for others to access based on which roles each one is setup for.

Data Extraction

Account Manager

Grant Access to All Data Extraction

This provides access to the Extract All Study Data option.

Data Extraction > Extract All study Data

Access batch PDF exports

Gives access to export entire subject casebooks for a given site. Users will only be able to export for sites they belong to.

Data Extraction > Batch PDF Exports

Data Management Report

Grant Access

Allows access to the data management report

Reports > Data Management Report

Deleted Records

Grant Access

Provides access to Deleted Records which displays all records that have been deleted in the study. This application will show deleted records across all sites in the study.

Subject > View Deleted Records

Undelete Records

Provides ability to UN-DELETE Records that have been deleted in the study. This application will allow un-deleted one records at a time.

File Repository

Grant Access

Provides access to the central File Repository which serves as a collection point for files/documents uploaded on CRFs or Site and Study documents. This application will list all documents uploaded throughout the study, regardless of the site.

Study > File Repository Manager

Delete Files

Allows the user to delete documents/files from the File Repository.

Double Data Entry

Grant Access

This provides access to the DDE Report used by a Double Data Entry Manager or similar role in studies designed to use multi-pass data entry. Studies not using DDE functionality do not need this right turned on.

Reports > DDE Report

Form Builder

Grant Access

This provides access to the Form Builder used to build the forms which will be used in the study.

Study > Form Builder

Add New Form

Allows the user access to create new forms on the 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.

Study > 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.

Study > Form Builder > 'Select' link in each row of the Existing Forms table

Export 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.

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

Import From Form Library

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

Study > Form Builder > 'Import Form' link below the Existing Forms table

Delete Form

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

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

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 forms or edit existing forms.

Study > Form Builder > 'Save' button on top of the form builder workspace

User Version Override on published forms

Allows the user to make changes to forms which exist on a published version. These changes are tracked in the Version Override Audit report

Study > Form Builder > Version override button

Import Manager

Grant Access

Allows the user to access the applications used to import external study data into TrialKit.

Study > Import Configuration / Run Import

Informed Consent

Grant Access

Provides access to the Informed Consent configuration

Study Configuration > Informed Consent

Configure Informed Consent

Allows the user to setup the informed consent configuration

Study Configuration > Informed Consent

Revoke Consent

Provides the user access to revoke consent at the form level when a consent form is open. Note, revoking consent can separately be accomplished from the consent report regardless of this permission.

Run Consent Report

Provides the user access to the consent report for tracking subject consent status/history across all sites

Reports > Consent Report

Populate all patients with paper consent

Allows user access to the function, within the informed consent configuration, to move all existing subjects to use an alternative method of consent so the system does not enforce electronic consent on those patients.

Informed Consent > Add informed consent

Prevent Resaving of Completed Consent

Prevents resaving a current completed consent form by the patient user.

Only applicable when applied to the subject/patient role.

Inventory
Administration

Grant Access

Allows the user to access the page 'Import Inventory' where inventories can be uploaded and deleted.

Study > Import Inventory

Reset Inventories

Allows the user to reset all items in inventory back to the beginning.

Study > Inventory Configuration

Inventory
Management

Grant Access

Allows the user to access the page 'Inventory Management' where inventory items can be managed. See the following permissions for more specific role security.

Subject > Inventory Management

Rollback/Undo Item transaction

Allows a user to undo the last event that occurred on an item. Normally utilized manually only by an Administrator user, and only available from the TrialKit mobile app.

TrialKit app > Inventory Manager > tap on an item to view its history and undo the last transaction that occurred.

Allocate Inventory to Sites

Allows a user to manually release inventory items to sites

Inventory Manager

Receive Inventory at Sites

Allows a user to accept inventory items at the site in order to make the items available for allocation to subjects at that site.

Inventory Manager

Assign Inventory to Subjects

Allows a user to assign inventory items to subjects within the CRF where inventory item is selected.

Subject Records

View Non-allocated Items

 Allows a user to view all items in the inventory for any site(s) they belong to, plus all un-allocated items not yet assigned to a site or subject.

Inventory Manager

Always Blind Types

Blinds all details of the inventory items except for the item identifier. These details are defined by the Administrator when setting up an Inventory. For inventories which are tied to a blinded randomization, this will prevent un-blinding.

Inventory Manager

Medical Coding

Grant Access

Allows the user to access the Medical Coding page.

Subject > Medical Coding

Add New Configuration

Allows User to create new coding configurations for other data sources

Subject > Medical Coding > "Add New Configuration" form

Edit Existing Configuration

Allows user to edit coding configurations

Subject > Medical Coding > "Edit" column

Delete Existing Configuration

Allows users to delete coding configurations/projects

Subject > Medical Coding > Delete icon

Access Coding Tool

Allows users to open coding projects from the Projects page in csCoder and perform coding

Subject > Medical Coding > "Code This" column

Mobile Uploads

Grant Access

Allows the user to access the Mobile Uploads page. This is only necessary for users who want to use the app to setup randomization or medical coding, but need a way to upload files to continue setting up on the app.

Website Host >Mobile Uploads

Upload Randomization File

Allows the user to see an upload field for randomization on the mobile uploads page

Website Host >Mobile Uploads

Upload Medical Coding File

Allows the user to see an upload field for medical coding on the mobile uploads page

Website Host >Mobile Uploads

Monitor Report

Grant Access

Provides access to the Monitor Report and the Field Locking Report, which are used to display fields that have been reviewed/locked, fields that have been unlocked, or records in the midst of being monitored using the soft review function.

Reports > Monitor Report, FLSV Report

My Queries Report

Grant Access

Allows the user to access My Queries Report, which displays the queries applicable to their role.

Reports > My Queries Report

Notification Management

Grant Access

Allows access to the Participant Notifications screen - Site membership enforced

Subject > Participant Notifications

Pages Granted to All Users

Grant Access

This gives users access to the pages that are common and non-impactful to study access or data. These include the following screens:

• Contact Us

• Version Information

• Change password

• Home page

• System error pages

Various

Payment Configuration

Grant Access

Allows the user to access payment configurations for setting up the payment tracking system

Study > Configure Payments

Payment Manager

Grant Access

Allows the user to access payment configurations for setting up the payment tracking system

Study > Payment Manager

Query Management

Grant Access

No longer functional. The query management system has been enhanced so queries are deployed to the defined list of roles. Those roles will receive the queries in their My Queries Report and on the corresponding CRF without this right having been granted.

Create Query

Allows the user to create queries on each field of a CRF or the entire record. Query icons will appear next to each field in a CRF for users with this right.

Close Query

Allows the user to close queries so they are no longer open/active.

Query Dialog window and Queries report

Delete Query

Allows users to delete queries from within the query window, accessible from either My Queries Report or the CRF the query is part of. A query can be deleted by users with this right, whether the query is open or closed.

Query Dialog window within subject forms

Show All Queries

This right will a 'Show All Queries' checkbox above the Queries table in My Queries Report. This allows the user to see ALL queries in the study, rather than only the queries deployed to their role.

Reports > My Queries Report

Unlock Field (FLSV )

This right allows the user to unlock fields that may have previously locked by a Monitor (or other designated review level). 

Subject Forms

Bulk Close Queries

Adds batch close option within the Queries Report. This should only be granted along with the Close Query permission.

Queries Report

Prevent Editing Role Distribution

Prevents the user role from changing the role distribution when a manual query is created.

Query Dialog window

Query Summary Report

Grant Access

Allows access to the Query Summary Report which provides an overview of query counts per site.

Reports > Query Summary Report

Randomization Configuration

Grant Access

Allows access to the Randomization pages used for setting up the randomization schedule/allocations. There are two pages that correspond to this right (see menu location)

Study > Define randomization

Study > Import randomization file 

Randomization View        

Grant Access

Allows access to view the randomization schedule and allocations made within the study.

Subject > View randomization allocations

Unallocate Subject

Ability to see a link for unallocating subjects in the randomization table.

Subject > View randomization allocations

Report Builder

Grant Access

Allows access to the Report Builder application used to create/view custom reports on the study data. When reports are set up, the roles they are visible to are selected by the user who created the report. Therefore, users can have access to the Report Builder, but will only be able to view reports that were made available to them.

Reports > Report Builder

Create or Setup Report

Allows users to create reports in the Report Builder.

Reports > Report Builder

Delete Report

Allows users to Delete existing reports in the Ad-Hoc Reports table.

Reports > Report Builder > 'Delete' link in each row of the Reports table

Report Jobs

Grant Access

Provides access to the Job Status Report used for background processing of specific reports throughout the system that may take some time to run while the user continues working in the system.

Reports > Job progress report

Risk Based Monitoring

Grant Access

Allows access to RBM setup. Note, this is not needed by Monitors

Configure RBM

Allows ability to define rules for what gets Monitored.

This function is only available on the TrialKit app. If your role has it, you will see an RBM icon at the top of all subject CRFs.

Role Security

Grant Access

This right has been disabled. To provide users the right to access Role Security, check the Study Configuration settings listed below. Once a user is provided rights to access Role Security, the other rights in this section will be able to allow access to specified rights within Role Security.

Add New Role

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

Study > Study Configuration > 'Role Security' tab > Add or Edit Roles section

Edit Existing Role

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

Study > Study Configuration > 'Role Security' tab > Add or Edit Roles section

Delete Existing Role

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

Study > Study Configuration > 'Role Security' tab > Add or Edit Roles section

Grant Rights to any Role that have not been granted

Grant Form Rights

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

Study > Study Configuration > 'Role Security' tab > 'Form Rights' link at the top of the rights section

Blind Fields

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

Study > Study Configuration > 'Role Security' tab > 'Blind Form Fields by Role' link above the rights section

Scheduling

Grant access to participant scheduling

Gives the user access to the study calendar for the user’s current site (site membership enforced).

Subject Manager - Scheduler

View Entire Study Schedule (All sites)

Allows the user to see all sites/subjects in a single view when looking at the calendar. Without this, events from the current site only are shown.

Create New Events

Ability to create new calendar events

Modify Existing Events

Ability to update existing events with changes

Delete Existing Events

Ability to delete existing events

Send Meeting Invitation to Participant

Ability to send meeting invite to a patient user if their email is registered

Access Calendar Report

Access to the calendar report or exported file

Import ICS Calendar Events

Ability to import an ICS format calendar file from an external calendar

Site by user report

Allows access to the site by user report for listings of all user, which sites they belong to and the roles they serve at each.

Reports > Site by user

Site Document Manager

Grant Access

Gives users access to the Site Document Manager application where they can then access any site-type forms created in the Form Builder. They will only see the site forms for sites which they belong to.

Study > Site Document Manager

Setup Site Documents

Allows users to make changes to the site document study requirements.

Study > Site Document Manager > 'Subject Enrollment Rules' and 'Approved to Enroll' settings

Lab Normal Ranges

Allows users to associate lab sites with study sites, which can then be selected by data entry personnel on a lab form for range validation purposes.

Delete Site Documents

Allows users to delete records within the Site Document Manager

Site Document Manager

Study Configuration

Grant Access

Allows the user to access the Study Configuration page and the Device Manager list. The other Study Configuration rights below will allow more granular control over specific controls within study configuration.

Study > Study Configuration

Access To Events Without a Site