After the study roles have been configured, this guide can be used to help you define each permission.  


User roles vary for most studies, but feel free to reference this template for the most common user roles and corresponding permissions.


The table below displays all the permissions that can be configured in Clinical Studio. Each permission listed also contains a link to the help article where it applies. 



ApplicationPermissionsDefinition
AccelEDCGrant AccessAllows access to AccelEDC API for automatically importing PDF data into a study

Location:
Accessible through the Subject Manager and subject records
Access Study Related FormsGrant Access

This right will grant access to the menu item. 

Allowing access to this application will depend on the form content and the user roles that will be entering data in these forms.


Menu location:

Subject > Access Study Related Forms

Action Item ReportGrant 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.


Menu location:
Reports > Action Item Report

Coordinator Action ItemsFor 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).

Menu location:
Reports > Action Item Report > Section titled Research Coordinator Action Items

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 ItemsThis 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.
Adjudication
Grant AccessAllows 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 ReportAllows access to the adjudication report. Only available on the TrialKit app.

Moderator ReportAllows access to adjudication moderator report. Only available on the TrialKit app.
Build Web pagesGrant AccessThis 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.


Menu location:
Website Host > Build Web Page
Dashboard ReportGrant 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.


Menu location:

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.


Menu location:

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.


Menu location:

Study > Study Configuration

Data ExtractionGrant AccessThis right will give access to the Data Extraction menu and the application which corresponds to it.


Menu location:
Data Extraction
Data Management ReportGrant AccessAllows access to the data management report

Menu location:
Reports > Data Management Report
Deleted RecordsGrant 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.


Menu location:

Subject > View Deleted Records


Undelete RecordsThis function has been turned off until further notice. Selecting this right has no effect on the study.
Document ManagerGrant Access

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


Menu location:

Study > Study Document Manager


Delete Uploaded Files

Allows the user to delete documents/files from the Study Document Manager OR from the form which the document is uploaded to.

Double Data EntryGrant 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.


Menu location:

Reports > DDE Report

Form BuilderGrant Access

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


Menu location:

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.


Menu location:

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.


Menu location:

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.


Menu location:

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.


Menu location:

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.


Menu location:

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


Save Changes to FormAllows 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.


Menu location:

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

Import ManagerGrant AccessAllows the user to access the applications used to import external study data into Clinical Studio.


Menu location: 

Study > Import Configuration / Run Import

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

Menu Location:
Study > Import Inventory
Inventory
Management
Grant AccessAllows the user to access the page 'Inventory Management' where inventory items can be managed. See the following permissions for more specific role security.

Menu Location:
Subject > Inventory Management
 Allocate Inventory to Sites
 Receive Inventory at Sites 
 Assign Inventory to Subjects 
 Receive Rejected Inventory at Supplier 
Lab Range ManagerGrant AccessAllows access to the Lab Range Management application used to set up the various lab range validations associated with various sites across a study.

Menu Location:
Study > Lab Range Manager

Add New Lab

Edit Existing Lab

Delete Existing Lab
Medical CodingGrant AccessAllows the user to access the Medical Coding page.

Menu Location:
Subject > Medical Coding
 Add New ConfigurationAllows User to create new coding configurations for other data sources

Menu Location:
Subject > Medical Coding > "Add New Configuration" form
 Edit Existing ConfigurationAllows user to edit coding configurations

Menu Location:
Subject > Medical Coding > "Edit" column
 Delete Existing ConfigurationAllows users to delete coding configurations/projects

Menu Location:
Subject > Medical Coding > Delete icon
 Access Coding ToolAllows users to open coding projects from the Projects page in csCoder and perform coding

Menu Location:
Subject > Medical Coding > "Code This" column
Mobile UploadsGrant AccessAllows 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.

Menu Location:
Website Host >Mobile Uploads

Upload Randomization FileAllows the user to see an upload field for randomization on the mobile uploads page

Menu Location:
Website Host >Mobile Uploads

Upload Medical Coding FileAllows the user to see an upload field for medical coding on the mobile uploads page

Menu Location:
Website Host >Mobile Uploads
Monitor ReportGrant AccessProvides 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.

Menu location:
Reports > Monitor Report, FLSV Report
My Queries ReportGrant Access

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


Menu location:

Reports > My Queries Report

Pages Granted to All UsersGrant Access

Grant Access to Pages Granted to All Users

Payment ConfigurationGrant Access

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


Menu location:

Study > Configure Payments

Payment ManagerGrant Access

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


Menu location:

Study > Payment Manager

Query ManagementGrant Access

This right has been disabled. Enabling or disabling this right will have no effect on the study or users' access to queries. The query management system has been enhanced so queries are deployed to selected roles. Those roles will receive the queries in their My Queries Report and on the corresponding CRF without this right having been granted. However, all other query management rights will affect what users are able to do within the query system.


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

Delete QueryAllows 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.

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.


Menu location:

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


Menu location: 

Reports > Query Summary Report

Randomization ConfigurationGrant Access

Allows access to the Randomization pages used for setting up the randomization schedule/allocations. There are two pages that correspond to this right:

Menu location:

Study > Define randomization

Study > Import randomization file 

Randomization View        Grant AccessAllows access to view the randomization schedule and allocations made within the study.

Menu location:
Subject > View randomization allocations
Report BuilderGrant 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.


Menu location:

Reports > Report Builder


Create or Setup ReportAllows users to create reports in the Report Builder.


Menu location:

Reports > Report Builder


Delete Report

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


Menu location:
Reports > Report Builder > 'Delete' link in each row of the Reports table
Report JobsGrant AccessProvides 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 MonitoringGrant AccessAllows access to RBM setup. Note, this is not needed by Monitors

Configure RBMAllows ability to define rules for what gets Monitored.

Location:
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 SecurityGrant 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 RoleAllows users to add new roles to the Add/Edit Roles section of Role Security.


Menu location:

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


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


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

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


Menu location:
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.


Menu location: 

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.


Menu location: 

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

Site by user reportGrant accessAllows 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 ManagerGrant 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.


Menu location:
Study > Site Document Manager

Setup Site DocumentsAllows users to make changes to the site document study requirements.


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

Lab Normal RangesAllows 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.
Study ConfigurationGrant Access

Allows the user to access the Study Configuration page. The other Study Configuration rights below will further all specific rights on the Study Configuration page.


Menu location:
Study > Study Configuration

Import Review Fields

Configure Functionality

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


Menu location:
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.


Menu location:
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.


Menu location:
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.


Menu location:
Study > Study Configuration > 'Workflow' tab

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


Menu location:
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. Also note this right is independent of the Version Control right.


Menu location:
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.



Menu location:
Study > Study Configuration > 'Metrics' tab

Configure Audit System

Allows access to the Audit tab on the Study Configuration page. This is used to set up the requirements for how Clinical Studio should audit the study data.



Menu location:
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.


Menu location:
Study > Study Configuration > 'DDE' tab
Study Progress ReportGrant AccessAllows access to the study progress report for downloading.

Menu location:
Reports > Study Progress Report
Subject Audit ReportGrant Access

Allows users access to the Subject Audit Report, which displays all audit information on data for the entire study. Important note prior to allowing access - Users with this right will see subject data for ALL sites in the study. It is designed to be an Admin-level report.


Menu location:
Reports > Subject Audit Report
Subject Record ManagementGrant AccessAllows 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.


Menu location:
Subject > Subject Manager

Register New Subject

Allows users to register/enroll subjects in the sites they belong to. This will also allow users to fill out the enrollment form for newly registered subjects, regardless of those users' rights to view/edit subject registration.


Menu location: 

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.


Menu location:
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.


Menu location:
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.


Menu location:
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. 


Menu location: 

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


Only edit subject portion of IDWhen 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 RecordsAllows 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.


Menu location: 

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


Add Subject Event RecordsAllows users to fill out subject event records that are available on the subject records page.


Menu location: 

Subject > Subject Manager > 'Subject' profile ID link in the first column of the Subject Enrollment table > Any of the icons displaying the plus symbol in the visits/events table will allow the user to add those records.


View Subject Event Records

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


Menu location: 

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. 


Menu location: 

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 Form

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


Menu location: 

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


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

Batch Lock/Sign Record***

Allows a user who is responsible for reviewing records to batch lock and sign off on records. This right will display a link in the Action Item Report below the table of forms awaiting review. 


Menu location: 

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


Unlock RecordRecords are automatically locked after they have been reviewed. This right allows users to unlock records that have been locked. Note: This is unrelated to the 'Freeze Form' right listed below.

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 it.


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 DiaryAllows 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 TableThis 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 SubjectAllows for completely wiping a subject from the database. This includes being cleared from ePRO and randomization tables. This is not reversible and should be a permission granted with caution.
This permission must be granted in conjunction with the Delete Subject permission.

Function location:
Only available in the TrialKit app via the Study Configuration menu.

Clear All non-provider DataThis 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. 


Menu location: 

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


Show Study Build ProgressThis causes a 'Progress' link to be displayed on the upper right header of 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 FormThis 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 ClerkThis 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 ModeThis allows the user to access a button at the top of ePRO forms within the TrialKit app. The button is used prior to handing off  a device to a study subject for them to fill out a form. 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.

Function location:
Icon displays at the top of ePRO forms when being accessed in the Trialkit app

Allow Access to All Subjects

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. 


Menu location: 

Subject > Subject Manager

Subject Record page DesignGrant AccessThis allows users to access and edit scheduled and unscheduled visits page design.

Menu location: 

Study > Create or Edit Scheduled/Unscheduled Visits

Text ManagementGrant 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. 


Menu location: 

Study > Translate DB Text


Add Text

Change Text

Delete Text
Theme ManagerGrant Access

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


Menu location: 

Study > Theme Manager

Version ControlGrant Access

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


Menu location: 

Study > Version Manager


*** Batch and lock permission should only be granted to users that have review levels

Also be sure to read about: