Managing CDMS Study Roles


Vault CDMS offers a security model allowing users to have different roles in different studies. This model leverages the Application Role object to define user access at the object level (in this case, the Study object), instead of at the account level. Your Application Role extends your permissions granted by your Security Profile. These combined represent the Study Role, a permission grouping that you can manage from Tools > Role Management.

Users with the appropriate permissions can manage access to standard Vault CDMS functionality from Tools > EDC Toolsand create custom study roles from Tools > Role Management.

With the 19R2 release, we relabeled “Application Role” as “Study Role” in CDMS. In Vault Admin, the label remains “Application Role.”

You can learn more about dynamic access control here. See Vault EDC Security Profiles and Vault Coder Security Profiles a list of standard Security Profiles and Permissions Sets.

Accessing Role Management

To access the Role Management area, click the Tools tab in the top navigation bar, and then click Role Management.

Tools > Role Management navigation tabs

Custom vs. Standard Study Roles

For your convenience, several standard Study Roles are available by default. 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.

Vault groups Study Roles in the role table by Custom and Standard. Standard Study Roles names start with “CDMS”. All other roles are custom Study Roles in your vault. See this list of standard Study Roles.

Custom and Standard Role Table Headers

Viewing Roles

In the Role Management tab, Vault CDMS displays Study Roles and their permissions as a table. Each column represents a Study Role, and each row in the table represents a functional permission.

Functional permissions are divided into two sections: Standard Tabs and Functions. In the Standard Tabs section, there is a permission row for the ability to access each standard navigation tab. In the Functions section, there is a row for each standard function, such as Data Entry or Add Casebook, that a user may perform in Vault CDMS.

In the current release, Vault does not display any permissions related to custom objects or tabs in Role Management.

Role Management role table

For each Study Role column, Vault displays the number of users that are assigned that Study Role in the Number of Users row.

Number of users row

You can click on the Number to view a list of those Users. From that dialog, you can filter the list by Study or search for a specific User.

Users with the CRA role dialog

Collapse & Expand Permission Sections

Vault groups functional permissions together. For easier viewing, you can collapse and expand sections as you scroll through the page.

Click the Collapse () or Expand () buttons to collapse and expand sections.

Creating & Editing Roles

You can create and edit custom Study Roles from Tools > Role Management. See details here.

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

Standard CDMS Study Roles

The following Study Roles are standard and available as part of the CDMS Role by Study feature.

Study Roles related to the CDMS Role by Study feature have “CDMS” in their name. Any roles without “CDMS” instead are custom Study Roles in your vault. Each standard Study Role has a standard Security Profile assigned. See details about Vault EDC Security Profiles here and Vault Coder Security Profiles here.

Role Security Profile Description
CDMS Auditor Read Only Read Only This role provides read-only permission on all study execution data. This role can export detail and blank PDFs but cannot perform any other actions within Vault CDMS.
CDMS Clinical Coder Coder This role provides all access required of an end-user for the Coder application. This role allows users to code, create and close queries, and create notes.
CDMS Clinical Coder Administrator Coder Admin This role provides complete access to the Coder application, including the ability to manage settings and lists from Coder Tools.
CDMS Clinical Research Associate Data Review This role provides data review access, with the ability to create and close queries, perform SDV, and generate PDFs.
CDMS Clinical Research Coordinator Data Entry This role provides data entry access, with the ability to enter data, answer queries, and export PDFs.
CDMS Data Manager Data Manager This role provides access for data review with the ability to create and close queries, perform DMR, and generate PDFs. This role also provides the ability to interact with the EDC Tools area, with the ability to manage amendments, sites, study countries, query rules, and run ad hoc jobs.
CDMS Lead Data Manager Lead Data Manager This role provides access for data review with the ability to create and close queries, perform DMR, lock data, lock studies and sites, and generate PDFs. This role also provides the ability to interact with the EDC Tools area, with the ability to manage amendments, sites, study countries, query rules, and run ad hoc and schedule recurring jobs.
CDMS Principal Investigator Data Entry This role provides data entry access, with the ability to enter data, answer queries, and export PDFs. This role also provides the ability to provide electronic signatures.
CDMS Sub Investigator Data Entry This role provides data entry access, with the ability to enter data, answer queries, and export PDFs.
CDMS Study Designer Design This role provides study design access, with the ability to create and manage definition object records in Studio, run ad hoc jobs (from within Studio), and view reports and dashboards,
CDMS User Administrator User Administrator This role provides complete access to the Vault CDMS application to allow users with this role to manage user accounts and access.

Users with the Vault Owner security profile or the User Administration security profile and CDMS User Administrator study role can perform the actions described above by default. If your vault uses custom Security Profiles or Application Roles, 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