Creating & Editing Study Roles in Role Management


For your convenience, several standard Study Roles are available by default. You can see a list of those standard roles here. You can assign these standard roles to users in your study, or you can assign your users custom roles. You can copy the standard Study Roles to use as a template when creating your custom roles as well.

This feature is available in vaults where Role by Study is enabled. Contact Veeva Services to enable Role by Study in your vault.

Creating a Custom Role

You can create Study Roles from scratch or by copying an existing Study Role. If you create a new Study Role from scratch, there are additional configuration steps you must perform for your new role to become functional.

Once you create a custom Study Role, a user administrator can assign it to users in your Study immediately. However, it may take up to 4-6 hours before a user with the new role can view data, due to the processing that Vault performs as part of role creation. We recommend that you create custom roles first to allow time for processing to finish before your users begin work.

New Study Role

To create a new Study Role from scratch:

Create the Role

To create a new role:

  1. Navigate to Tools > Role Management.
  2. Click + New Role. + New Role button

  3. Enter a Name for your new role. Note that this Name must be unique at the vault level. New Role dialog, with no entries for Name or Copy from Role

  4. If you are creating a custom role from scratch, don’t select a role in Copy from Role.
  5. Click Save. New Role dialog with the Name Verteo Investigator entered

  6. Select the permissions that you want to assign this role in the Standard Tabs and Functions sections. Selecting the permission assigns the permission. If you don’t select a permission, this role will not have that permission. Custom Role in Edit Mode

  7. Click Save.
  8. Vault creates a custom Security Profile and Permission Set with the appropriate permissions and maps it to your new Study Role. If you want to assign permissions for custom objects and tabs, you can perform that configuration now. See details here.

Copy from Existing Role

To create a new Study Role by copying an existing or standard Study Role:

  1. Navigate to Tools > Role Management.
  2. Click + New Role. + New Role button

  3. Enter a Name for your new role. Note that this Name must be unique at the vault level. New Role dialog, with no entries for Name or Copy from Role

  4. Select a standard Study Role in Copy from Role. Vault copies this Study Role into your custom Study Role. Copy from Role expanded in the New Role dialog

  5. Click Save.
  6. Select the permissions that you want to assign this role in the Standard Tabs and Functions sections. Selecting the permission assigns the permission. If you don’t select a permission, this role will not have that permission.
  7. Click Save.
  8. Vault creates a custom Security Profile and Permission Set with the appropriate permissions and maps it to your new Study Role. If you want to assign permissions for custom objects and tabs, you can perform that configuration now. See details here.

Editing Custom Roles

You can edit custom Study Roles from Tools > Role Management as needed.

When you edit a custom Study Role, Vault immediately applies those changes to every user with that role assigned.

To edit a custom Study Role:

  1. Navigate to Tools > Role Management.
  2. In your custom role’s column, click Edit (pencil icon). Edit Role button (pencil icon)

  3. Select and deselect permissions as needed.
  4. Click Save.

Rename a Role

You can rename custom Study Roles as needed.

To rename a custom Study Role:

  1. Navigate to Tools > Role Management.
  2. In your custom role’s column, click Edit (pencil icon). Edit Role button (pencil icon)

  3. Click Rename. Rename button for a custom role

  4. In the Rename Role dialog, enter a new Name. Rename Role dialog

  5. Click Save.

Functional Permissions

The functional permissions listed in Role Management represent a combination of Application Role and Security Profile based permissions. In Tools > Role Management, each row represents either a functional permission or the ability to access a standard tab (such as Data Entry or Coder) in Vault CDMS. A selected (checked) permission indicates that a role has this permission.

This table lists each functional permission and a description of what it controls.

Functions

You can control access to various application functions from the Functions section of the role table:

Field Controls
Edit SDV

Ability to perform SDV

View SDV

Ability to view SDV status

Open Query

Ability to create new (open) queries

Answer Query

Ability to answer queries

Close Query

Ability to close queries

View DMR

Ability to view DMR status

Edit DMR

Ability to perform DMR

Sign

Ability to provide an electronic signature on study data

Execute Query Rules

Ability to execute query rules via the Query Rules job in EDC Tools

Manage Coding Lists

Ability to create, edit, import, and export Synonym Lists and Do Not Autocode Lists in Coder Tools

Data Entry

Ability to enter study execution data

Freeze Data

Ability to freeze and unfreeze data

Lock Data

Ability to lock and unlock data

Generate Detail PDF

Ability to export detail PDFs

Generate Blank PDF

Ability to export blank PDFs

Manage Users

Ability to create and edit Users and their access

Manage Study Lock

Ability to lock and unlock Studies and Sites from EDC Tools

Manage Study Sites

Ability to create and edit Sites from EDC Tools

Manage Jobs

Ability to create, edit, and delete scheduled jobs

Manage Amendments

Ability to initiate subject transfers, retrospective amendments, and prospective casebook amendments, from EDC Tools

Manage FTP

Ability to create and edit FTP Connections in EDC Tools

Manage Study Countries

Ability to create and edit Study Countries in EDC Tools

Assign Code

Ability to assign codes in Coder

Manage Coder Study Settings

Ability to edit Study Settings in Coder Tools

Add Casebook

Ability to add new Casebooks

Delete Casebook

Ability to delete subject Casebooks and related object records

Edit Clinical Assessments

Ability to perform (edit) Assessments

View Clinical Assessments

Ability to view completed Assessments

Manage Assessments

Ability to assign Study Roles to Assessment Definitions from EDC Tools > Assessments

Manage Review Plan Assignments

Ability to access EDC Tools > Review Plan Assignments and update the study- and site-level templates

Manage Study Deployments

Ability to create and manage study Environments and deploy Studies from EDC Tools

View Casebook

Ability to view subject Casebooks

Design Study

Ability to create study design definitions and a study schedule from Studio

Schedule Reports

Ability to create and schedule flash reports

Standard Tabs

You can control access to the following standard tabs from the Standard Tabs section of the role table:

Field Controls
Assessments Tab

Ability to access the Assessments tab

Coder Tab

Ability to access the Coder tab

Coder Tools Tab

Ability to access the Coder Tools tab

Data Entry Tab

Ability to access the Data Entry tab

EDC Tools Tab

Ability to access the EDC Tools tab

Reports Dashboards Tab

Ability to access the Reports and Dashboards tabs

Review Tab

Ability to access the Review tab

Role Management Tab

Ability to access the Role Management tab

Studio Tab

Ability to access the Studio tab

Multiple Roles in a Vault

If a user in your Vault has multiple Study Roles assigned in different Studies, you may need to create a custom Security Profile and map it to the custom Study Role to ensure that they have the permissions they need.

For example, if Amir is a lead data manager for the Deetoza study, but he also acts as an auditor for the Veeofen study, he will need a custom security profile to ensure that he has the appropriate access in both Studies.

Users must have the Vault Owner security profile, or a custom permission set granting access to create and edit Security Profiles and Users from Admin > Users & Groups, to perform this configuration.

When you create a custom Study Role, Vault automatically creates a Permission Set that contains all of the access and permissions specified in Tools > Role Management. You can assign the Permission Set from each role to the custom Security Profile for this user.

  1. From Admin > Users & Groups > Security Profiles, create a new Security Profile and assign the Permission Sets for both custom roles to the Security Profile.
  2. From Admin > Users & Groups > Users, assign the new custom Security Profile to your user.
  3. From Tools > EDC Tools, add the user to both Studies, assigning the chosen custom Study Roles.

Study Roles for Custom Configuration

If you create custom objects and custom tabs in your vault, you must perform additional security configuration to manage access using Study Roles.

  • Create a Permission Set (or more than one) that assigns access to those objects and tabs.
  • Either add that Permission Set to the existing Security Profile for your custom role (this profile has the same name as your custom Study Role) or create a Security Profile that has that Permission Set assigned, as well as any other Permission Set that a user would require to use vault with that profile.
  • Configure dynamic access control and field-level security for your custom object.
  • If you created a custom Security Profile update the Application Role Security Profile Rel mapping record for your custom Study Role to reference the custom Security Profile.

Mapping a Security Profile to a Custom Study Role

Vault uses the Application Role Security Profile Rel object to connect Study Roles (Application Roles) and Security Profiles. If you created a custom Security Profile for a Study Role to provide access to custom configurations, instead of updating the existing Security Profile for your Study Role, you must map the new Security Profile to the Study Role by updating the Application Role Security Profile Rels record for your role.

To update an Application Role Security Profile Rel record:

  1. Navigate to Admin > Business Admin > Security Profiles.
  2. Locate your custom Security Profile in the object record list.
  3. Copy or make a note of the Profile Name field value.
  4. Navigate to Admin > Business Admin > Application Role Security Profile Rels.
  5. Locate the record for your custom Study Role in the object record list.
  6. Click to open that record.
  7. Click Edit.
  8. In the Security Profile field, remove the existing value.
  9. Paste or enter the copied Profile Name into the Security Profile field.
  10. Click Save.

Users with the Vault Owner security profile, the CDMS Lead Data Manager study role, or the CDMS User Administrator study role are able to perform the actions described above by default.

If you have a custom Study Role, you must have the following permissions:

Type Permission Label Controls
Functional Permission Role Management Tab

Ability to access the Role Management tab

Functional Permission Manage Users

Ability to create and edit Users and their access

To perform the configuration for users with multiple roles in a vault or Study Roles for custom configurations, you must also have the following permissions:

Type Permission Label Controls
Security Profile Admin: Security: Security Profiles: Create, Edit Ability to create and edit Security Profiles
Security Profile Admin: Security: Permission Sets: Create, Edit Ability to create and edit Permission Sets
Security Profile Admin: Configuration: Tabs: Create, Edit Ability to create and edit tabs
Security Profile Admin: Configuration: Objects: Create, Edit Ability to create and edit objects and their configuration
Security Profile Admin: Configuration: Object Lifecycles: Create, Edit Ability to create and edit Object Lifecycles
Security Profile Objects: Application Role: Create, Edit Ability to create and edit Application Role object records
Security Profile Objects: Application Role Security Profile Rel: Create, Edit Ability to create and edit Application Role Security Profile Rel object records
Security Profile Objects: Application Role Function: Create, Edit Ability to create and edit Application Role Function object records
Security Profile Objects: User: Create, Edit Ability to create and edit User object records

Learn more about permission-sets.


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