Study Roles and Permissions

Application

Permission

Definition

Location

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

This should only 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

Provide Change Reasons In Batch

Allows the user to provide a single reason for change to a group of records that are currently flagged for data changes and awaiting reasons.

Note: this will apply to any records that the user is currently filtering the table for.

Action Items Report > Data Changes Awaiting Reason

Bypass Review Levels

Allows the user to bypass any record at its current review level, even if the user’s role is not a reviewer role.

Action Items Report > Review Levels

Adjudication

Grant Access

Allows access to form adjudication. Any role defined in the form builder as an adjudication level should have this permission.

 Any form that is set up to be adjudicated

Adjudication Report

Allows access to the adjudication report.

Reports menu

Moderator Report

Allows access to adjudication moderator report.

Mobile App, Reports menu

Configure Adjudication

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

Mobile App, Study menu

AI Analytics

Grant Access

Provides the user with a an AI Analytics button at the top of the site for accessing the AI reporting tool.

Header area of the website

Background Exports

Grant access to background export jobs

Adds option under the Reports menu to access a list of any background jobs the user has initiated. Users only see their own jobs, so this is normally okay to grant to all users.

Reports menu > Background Export Jobs

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 By Form

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 the user has been given.

Data Extraction > Extract Data By Form

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

Field blinding is supported in PDF exports, but form Viewing permissions are not.

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 one records at a time to be un-deleted. 

eDiaries

eDiary Configuration

Gives access to Participant ediary configuration screen

eDiary Configurations

Interval Diary Notification Report

Access to the interval diary notification report

Reports > Interval diary notifications

Event Diary Notification Report

Access to the event diary notification report

Reports > Event diary notifications

Event Diary Configuration

Access to the event diary configuration screen

Event Schedules

DICOMs

Access to DICOMs

Gives the user access to View and upload DICOM files within subject records.

Button on subject Casebook toolbar

Download DICOM files

Allows the user to download DICOM files from any DICOM listing

Subject’s DICOM report, accessible from the toolbar, or within buttons built into the form by the study builder

Delete DICOM files

Allows the user to delete DICOM files from any DICOM listing

Subject’s DICOM report, accessible from the toolbar, or within buttons built into the form by the study builder

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 makes 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 makes 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

Use 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 be accomplished separately 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.

This is 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 this is only manually utilized by an Administrator user, and only available from the Mobile app.

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

Send Outgoing Products

Allows a user to manually release inventory items to another level.

Inventory Manager

Accept Incoming Products

Allows a user to accept inventory items into the corresponding inventory level. For Example, sites need to accept items that have been released to them.

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

Hide Subject Assignment

Hides the subject ID column within inventory manager so a user cannot view which items were allocated to certain subjects

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 Projects

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

Subject > Medical Coding > "Code This" column

Add/Edit Synonyms

User can add/import new synonyms and edit existing ones

TK Coder > Synonym library

Delete Synonym

User can remove existing synonyms from the synonym library

TK Coder > Coding projects table

Study Filter

Allows the user to filter the projects by study (only applicable for standalone coding environments).

To define/edit the study list, this permission is needed in conjunction with Edit existing configuration above.

TK Coder > Coding projects table

Mobile Uploads

Grant Access

Allows the user to access the Mobile Uploads page. This is only necessary for users who want to use the Mobile 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

• TrialKit Academy

• 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

Gives access to the other query permissions below. This is not necessary for a user to only view queries, but should be given to all users who will need to post messages on queries.

The query management system will automatically deploy queries to the roles that need visibility. Those roles will receive the queries in their My Queries Report and on forms without this right having been granted.

N/A

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.

Query Dialog window and Queries report

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 the My Queries Report or the CRF form where the query is located. 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.

Do not grant this permission of the role should only be able to close queries authored by their own role.

Queries Report

Prevent Editing Role Distribution

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

Query dialog window

Only Close Queries Authored By Same User       

Prevents a user with Close Query rights from closing Manual queries that they did not author.

This will not be enforced for batch closing queries, if the user also has that permission

Query dialog window

Only Close Queries Authored By Same Role

Prevents a user with Close Query rights from closing Manual queries that were authored by users of a different role.

This will not be enforced for batch closing queries, if the user also has that permission

Query dialog window

Query Summary Report

Grant Access

Allows access to the Query Summary Report which provides an overview of the 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

Deallocate Subject

Allows users the ability to see a link for deallocating 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 to which they are visible are selected by the user who created the report. When users can have access to the Report Builder, they are only able to view reports that are 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 which is used for background processing of specific reports throughout the system. These run in the background and may take time to run but the user can continue to work 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 the ability to define rules for what gets Monitored.

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

Role Security

Grant Access

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

Allows the user to see the role security application rights. This serves as a way to prevent removing an Admins own ability to update role security rights.

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.

Signature by Role Management

Grant Access to Signature by Role Management

Gives access to the Signatures By Role Report and to the ability to access consent records on unconsented subjects

Required Signatures by Role Report.

Subject Manager, unconsented subjects

View All Signature by Role Fields

Allows a user to view (not edit) all role-based signature fields regardless of which role they are assigned to.

Any form containing role-based signature fields

Sign All Signature by Role Fields

Allows the user to sign all role-based signature fields from the Signature by role report regardless of which role they are assigned to.

Note: the user must also have access to the report itself.

Required Signatures by Role Report 

Site by User Report

Allows access to the site by user report that is a listings of all users, 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. Here 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

Gives the user access to any event that has not yet been assigned to a site.

Import Review Fields

Allows a user to Administratively define risk-based monitoring for a study. This is accomplished through the web API only.

Configure Functionality

Allows access to the Study Functionality tab on the Study Configuration page. This is used to turn on/off general study attributes.

Study > Study Configuration > 'Functionality' tab

Configure Role Security

Allows access to the Role Security tab on the Study Configuration page, which will in turn allow users to alter Role Security for existing roles.

Study > Study Configuration > 'Role Security' tab

Configure Site and Users

Allows access to the Sites and Users tab on the Study Configuration page. This is used to manage the sites and users in the study.

Study > Study Configuration > 'Sites and Users' tab

Configure Workflow

Allows access to the Workflow tab on the Study Configuration page. This is used to set up the review levels on CRFs, and to define forms being used in the study.

Study > Study Configuration > 'Workflow' tab

Configure QMS

Allows access to the Query tab on the Study Configuration page. This is where the query management system is configured.

Study > Study Configuration > 'Query' tab

Configure Version Control

Allows access to the 'Version' tab on Study Configuration. This allows a user to create and edit study versions, publish, and view the differences between versions.

Note: This tab will only appear if 'Enforce Version Control' is turned on in the study functionality.

Note:  This right is independent of the Version Control right.

Study > Study Configuration > 'Version' tab

Configure Metrics

Allows access to the Metrics tab on the Study Configuration page. This is where basic study objectives (number of sites and subjects) are defined - which are then viewed by users in the Dashboard Report.

Study > Study Configuration > 'Metrics' tab

Configure Audit System

Allows access to the Audit tab on the Study Configuration page. This is used to enable system auditing of data entered in the study.

Study > Study Configuration > 'Audit' tab

Configure Double Data Entry

Allows access to the DDE tab on the Study Configuration page. This is where a study is set up to use double data entry functionality, and where the sites using DDE will be selected.

Study > Study Configuration > 'DDE' tab

Study Documents

Grant Access

This right will grant access to the study documents page itself. Within that, a user's access is based on which study forms they have permissions to view/edit.

Subject > Study Documents

Delete Study Documents

Allows users to delete study documents for which they have access.

Prevent File Downloading

Prevents downloading of files with subject forms. This does not apply to downloading files within eTMF.

Subject Manager > Subject forms

Study Event Report

Grant Access

Allows access to the Study Events Report and the wearables data exports (Healthkit Metrics).

Reports > Form data audits > Study Events Report

Study Progress Report

Grant Access

Allows access to the Study Progress Report for downloading.

Reports > Study Progress Report

Subject Audit Report

Grant Access

Allows users access to the Subject Audit Report, which displays all audit information on data for the entire study, but excludes audit information for forms that the user does not have view permissions for.

Important note:  Prior to allowing access - Users with this right will see data for ALL sites in the study. It is designed to be an Admin-level report.

Reports > Subject Audit Report

Subject Record Management

Grant Access

Allows access to the Subject Manager where subject records are accessed. Rights within the Subject Manager can be further broken down in the following rights of this section. This right will typically be allowed for all roles, as the subject manager is the primary application used in studies.

Subject > Subject Manager

Register New Subject

Allows users to register/enroll Participants in the sites to which they belong. This will also allow users to fill out the enrollment form for newly registered Participants, regardless of those users' rights to view/edit subject registration. See View Subject Registration permission two places down.

Subject > Subject Manager > 'Enroll New Subject' button below the Subject Enrollment table

Edit Subject Registration

Allows users to edit the subject enrollment form created when each subject is registered.

Subject > Subject Manager > 'Status' icon in each row of the Subject Enrollment table

View Subject Registration

Allows users to view the subject enrollment form after it has been created for each subject.

Note: A user may have the right to enroll subjects and initially fill out the enrollment form, but without this right, they cannot subsequently open that enrollment form to view. See Register New Subject permission two places above.

Subject > Subject Manager > 'Status' icon in each row of the Subject Enrollment table

Delete Entire Subject

Allows users to Delete subjects from the Subject Enrollment table. Deleting a subject will delete all records attached to that subject.

Subject > Subject Manager > 'Delete' link in each row of the Subject Enrollment table

Edit Subject Profile ID

Allows users to access an 'Edit' link on the Subject Enrollment table. This then allows them to edit the Subject Profile ID in the 'Subject' column of the Subject Enrollment table.

Note: Editing a subject profile ID will not be included in the audit data unless the Audit settings in Study Configuration are set to require a reason for change on data changes. 

Subject > Subject Manager > 'Edit' link in each row of the Subject Enrollment table

Only edit subject portion of ID

When users have the right to edit a subject ID (item listed above), they can also be granted or denied the ability to change the site prefix portion of the ID number when applicable. Checking this permission will prevent the user from editing the site prefix.

Access Subject Records

Allows users to select the subject profile ID link in the Subject enrollment table and access the subject record page where all the records for that particular subject are accessed. Without this right, the subject profile ID will simply not appear as a clickable link.

Subject > Subject Manager > 'Subject' profile ID link in the first column of the Subject Enrollment table

Add Subject Event Records

Allows users to fill out subject event records that are available on the subject records page.

View Subject Event Records

Allows users to open and view records from the subject records page.

Subject > Subject Manager > 'Subject' profile ID link in the first column of the Subject Enrollment table > Select any icon in the visits/events table to view the records

Edit Subject Event Records

Allows users to open and make changes to records on the subject records page. 

Subject > Subject Manager > 'Subject' profile ID link in the first column of the Subject Enrollment table > Select any icon on the visits/events table to view/edit the records

Delete Subject event records

Allows users to Delete subject records from the Ordered List of all Subject Records at the bottom of the subject record page.

Subject > Subject Manager > 'Subject' profile ID link in each row of the Subject Enrollment table > Longitudinal Subject Record View at the bottom of the subject record page > 'Delete' link in each row of the ordered records table

Deny Adding/Editing Unscheduled Visits

If checked, this prevents a user from adding unscheduled visits.

Subject > Subject Manager > Unscheduled Visits

Delete Document

Allows users to delete uploaded documents/files from upload fields within records.

Batch Review All Records

Allows a user who is responsible for reviewing records to batch lock and sign off on All records in their action items list

Reports > Action Item Report > 'Sign and Lock All Forms' link below the review table

Batch Review Selected Records

Allows a user who is responsible for reviewing records to batch lock and sign off on Selected records in their action items list

Reports > Action Item Report > 'Sign and Lock Selected Forms' link below the review table

Volume Batch Record Lock

Allows a user to review/lock all records at their own review level for a given site.

Subject Manager

Bypass Own Review Level

Allows the user to bypass their review on records that are ready to be reviewed, and where the user’s role is also the reviewing role (i.e. will not serve a purpose for non-reviewers).

Granting this along with the batch Review permission will allow for batch bypassing records.

Action Items Report > Review Levels

or

On the subject Forms

Unlock Record

Records are automatically locked after they have been reviewed. This right allows users to unlock records that have been locked. Users who are part of the workflow and are responsible for locking the records in the first place will inherently have the ability to unlock records. This permission does not apply to those users.

Display Field Change Audit

Allows the user to see an audit table at the bottom of each record. This audit table will display the field change history of that particular record. This information is also displayed in the audit report, regardless of this right.

Important Note: The field change audit will not display at the bottom of each record unless the Audit settings in Study Configuration require a reason for change on data changes. Remember: Audit data can always be accessed in the Audit Report by those with rights to the report.

Display Subject Migration Diary

Displays a table at the bottom of each subject record which provides information on the migration history of a subject between study versions. For example, if a subject is enrolled in the study during version one of the study, a change is made to the protocol, version 2 of the study is created, and the subject is migrated to version 2, that change will be audited and appear in the migration diary.

Display Record Diary

Allows users to see the Form Transaction Diary table at the bottom of each record, which displays the history of saving that has been performed. This is also displayed in the Audit Report.

Delete Table Row

Allows users to delete rows from a table that exists on a form. Forms can be designed with tables where information can be continually logged (this is different than a log form). This right lets a user delete individual rows from those tables.

Display Review History Table

This allows users to see a review history table at the top of records which have undergone review by a reviewing role in the study.

Wipe Subject

Allows for completely wiping a subject from the database. This includes being cleared from ePRO and randomization tables.  This permission must be granted in conjunction with the Delete Subject permission.

Important Note: This is not reversible and should be a permission granted with caution.

Only available in the Mobile App via the Study Configuration menu.

Clear All non-provider Data

This function has been disabled, so this right will have no affect on the study. To reset Administrative site data, it will need to be manually deleted.

Clear All Data

This allows users to remove all data from the study via a link on the Study Configuration page. It is recommended that this right remain turned off to ALL users. If an Administrative level user needs to clear the study data, they can temporarily enable the right to themselves, delete the data, and then disable the right again. 

Study > Study Configuration > 'Remove All Data' link on right side of the page

Show Study Build Progress

This causes a 'Progress' link to be displayed on the upper right header on every page. Selecting the link opens a study progress window which can be used to check off Study build progress. This is not necessary for most data entry users.

Freeze Form

This allows users to freeze records. A 'Freeze Form' link will be displayed at the top of every record. The right to freeze will also give users the right to Unfreeze records. Freezing a form simply prevents other users from making any changes to the record in any way. Once the form is unfrozen, changes can be made again.

Note: Freezing a form is a temporary action that can be taken at any point. This is different than a form which is 'Locked' after being reviewed.

DDE Clerk

This allows a user to access Double Data Entry forms and serve as a DDE user. DDE forms are defined in the Form Builder and can only be used with studies set up to use DDE functionality.

Manage Handoff Mode

This allows a Site Staff to access a button at the top of forms within the Mobile App. The button is used prior to handing off a device to a study Participant for filling out a form on a shared device. When handoff mode is enabled, it prevents the subject from leaving the form. Normally only Coordinators and Investigators would need this permission if ePRO is part of the study.

Icon displays at the top of  forms within the Mobile App only. It will not display if the form is not an ePRO form.

Switch Cohorts

This allows users to switch subjects from one study cohort to another.

Subject > Subject Manager

Access All Subjects at All Sites

This allows users to access all subjects in the Subject Manager for all sites in the study. Without this right, users only see subjects for the site(s) they belong to. Most studies will only provide this right to Administrators or Data Managers. 

If granted to a site level role, this permission will not give access to all data within various reports and data exports. For those, the user will need to be a direct member of the sites which they need access to.

Subject > Subject Manager

Hide Longitudinal List of Records

This hides the longitudinal record view on the subjects records page. The purpose is if a user role needs to be blinded completely to the existence of forms being entered in the study by others. This is one step further than simply removing Viewing permissions. It also makes it so the role cannot see the list of what has been entered on a subject.

Subject Records, bottom of page

Deny PDF Exporting

This REMOVES the ability to export PDFs.

Subject Manager

Deny Access to Participant PIN

For ePRO studies, when this is enabled, it will hide the Participant's access PIN

Subject Manager

Allow Participants to Edit Existing Records

Allows Participant users to edit completed forms in their completed forms list.

Note, this only applies to forms completed without errors and only on ePRO studies that have given participant access to completed forms

Participant portal > Completed Forms

Move Record

Allows the user to move an existing subject record to another visit or to another subject.

Any subject form

Subject Record Page Design

Grant Access

This allows users to access and edit the following:

• Scheduled visit configuration

• Unscheduled visit configuration

• eDiary Configuration

Study > Create or Edit Scheduled/Unscheduled Visits

Text Management

Grant Access

This allows access to the Translate Database Text application, which is used to change the text throughout the pages which will then be seen by the study users. Text can be changed for things like role names, menu option nomenclature, and page descriptions. This right is most commonly used by Administrator-level users to make translations for text in the system which may be unclear to study users. 

Study > Translate DB Text

Add Text

Change Text

Delete Text

Theme Manager

Grant Access

This allows users to access the Theme Manager application for customizing the look of the pages which users will see. 

Study > Theme Manager

EHR Bridge

Grant Access to EHR Bridge Utility

Allows access to the TrialKit Bridge button within subject casebooks, for extracting text from files and importing the text into forms

Subject casebooks, button on right side of screen

TrialKit Drive (Export Scheduler)

Grant Access

Allows access to TrialKit Drive screen for configuring scheduled exports to an external SFTP

Data Extraction > TKDrive

User Plot

Grant Access

Mobile App only: Allows access to the User Plotting map for seeing users who have logged into the study.

Study Configuration

Version Control

Grant Access

This allows users to access the Version Manager application used to move sites and subject between study versions. 

Study > Version Manager

Virtual Video Visits

Access Participant Video Visits

Gives the user access to virtual video meetings from the subject manager, calendar events, and access to the Video Rooms screen.

Subjects > Video Rooms