Managing Study Roles

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

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

See Standard CDMS Security Profiles for 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 System Tools. By default, this opens the Role Management page.

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.

Available Standard Study Roles

You can view a list of standard Study Roles and which permissions each role has here. The following standard Study Roles are available:

• CDB API Read Write:

  Users with this study role have read and write access to the CDB API.

• CDMS API Read Only:

  Users with this study role have read-only access to the CDMS API.

• CDMS API Read Write:

  Users with this study role have read and write access to the CDMS API. This role requires All Sites access.

• CDMS Auditor Read Only:

  Users with this role have read-only access to Vault EDC and can generate PDFs.

• CDMS Clinical Coder:

  Users with the CDMS Clinical Coder study role can access and use Vault Coder, as well as send queries to and receive queries from site users in Vault EDC. This role requires All Sites access.

• CDMS Clinical Coder Administrator:

  Users with the CDMS Clinical Coder Administrator study role can access and use Vault Coder, as well as use the Coder Tools administration area to manage application- and study-level settings for Vault Coder. This role requires All Sites access.

• CDMS Clinical Coder Manager:

  Users with the CDMS Clinical Coder study role can access and use Vault Coder, and they can approve Code Requests coded by clinical coders. This role requires All Sites access.

• CDMS Clinical Research Associate:

  Users the CDMS Clinical Research Associate study role can use Vault EDC to perform SDV, close queries, freeze data, access reports, and create PDFs.

• CDMS Clinical Research Coordinator:

  Users with the CDMS Clinical Research Coordinator study role can use Vault EDC’s to create Casebooks, fill and submit case report Forms, answer queries, access reports, and create PDFs.

• CDMS Data Manager:

  Users with the CDMS Data Manager study role can use Vault EDC to perform data management review, view DMR, create PDFs, access reports, and lock data.

• CDMS Deployment Administrator:

  Users with the CDMS Deployment Administrator role can create new study environments and deploy a study from one environment to another.

• CDMS Labs Data Manager:

  Users with this role have access to all functions within the Labs tab.

• CDMS Lead Data Manager:

  Users with this role have the ability to create and close queries, perform DMR, lock data, lock studies and sites, and generate PDFs. They can also 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 Librarian:

  Users with the CDMS Librarian role can create, manage, and test study designs within library Collections.

• CDMS Medical Assessment Editor:

  Users with this role are able to view and perform clinical assessments and view supplemental data related to those assessments.

• CDMS Medical Assessment Reader:

  Users with this role are able to view clinical assessments and supplemental data related to those assessments.

• CDMS Principal Investigator:

  Users with this role can use Vault EDC to create Casebooks, fill and submit case report Forms, answer queries, access reports, provide signatures, and create PDFs.

• CDMS Randomization Manager:

  Users with this role are able to configure Randomization and manage Randomization Lists.

• CDMS Safety Administrator:

  Users with this role have access to EDC Tools > Safety Configuration to set up the Safety Clinical Data Link in their study.

• CDMS Study Designer:

  Users with the CDMS Study Designer study role can use Vault EDC Studio to create and design their studies in non-production environments.

• CDMS Study Designer Read Only:

  Users with the CDMS Study Designer Read Only study role can access Studio in read-only mode.

• CDMS Sub Investigator:

  Users with the CDMS Sub Investigator study role can use Vault EDC to create Casebooks, fill and submit case report Forms, answer queries, access reports, and create PDFs.

• CDMS Super User:

  Users with this study role can access all areas of the application and perform all actions within those areas. This role is only available in non-production environments.

• CDMS User Administrator:

  Users with this role can manage user accounts and access within Vault CDMS.

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 three (3) sections: Standard Tabs, Permissions, and User Defined Objects. If multi-role security is enabled in your vault, then there is also a User Defined Permission Sets section. In the Standard Tabs section, there is a permission row for the ability to access each standard navigation tab. In the Permissions section, there is a row for each standard function, such as Data Entry or Add Casebook, that a user may perform in Vault CDMS. Lastly, in the User Defined Objects section, there is a row for each qualifying custom object, and three rows for the Read, Edit, and Delete permissions on that object. In the User Defined Permission Sets section, there is a row for each User Defined Permission Set configured for the vault, which can control the ability to access user defined objects and tabs.

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

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.

Exporting the Role & Permission Matrix to Excel™

You can export a list of Study Roles, both standard and custom, and the permissions assigned to them as an Excel™ spreadsheet.

To export role mappings:

1. Navigate to Tools > System Tools > Role Management.

2. Click Download.

3. Vault creates your export file (“Role Management {DateTime}.xlsx”) and the download begins right away. When finished, you can open the file in Excel™.

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.

Standard Tabs

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

Permissions

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

Standard Study Roles & Security Profiles

21R1 & Earlier

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 standard Security Profiles here.

In vaults created after the 21R2 (August 2021) release, or vaults where multi-role security has been enabled, all Study Roles use the same Security Profile, CDMS All Access.

Role	Security Profile	Description
CDB API Read Write	CDB API Read Write	Users with this study role have read and write access to the CDB API.
CDMS API Read Only	CDMS API Read Only	Users with this study role have read-only access to the CDMS API.
CDMS API Read Write	CDMS API Read Write	Users with this study role have read and write access to the CDMS API. This role requires All Sites access.
CDMS Auditor Read Only	CDMS Auditor Read Only	Users with this role have read-only access to Vault EDC and can generate PDFs.
CDMS Clinical Coder	CDMS Clinical Coder	Users with the CDMS Clinical Coder study role can access and use Vault Coder, as well as send queries to and receive queries from site users in Vault EDC. This role requires All Sites access.
CDMS Clinical Coder Administrator	CDMS Clinical Coder Administrator	Users with the CDMS Clinical Coder Administrator study role can access and use Vault Coder, as well as use the Coder Tools administration area to manage application- and study-level settings for Vault Coder. This role requires All Sites access.
CDMS Clinical Coder Manager	CDMS Clinical Coder Manager	Users with the CDMS Clinical Coder study role can access and use Vault Coder, and they can approve Code Requests coded by clinical coders. This role requires All Sites access.
CDMS Clinical Research Associate	CDMS Clinical Research Associate	Users the CDMS Clinical Research Associate study role can use Vault EDC to perform SDV, close queries, freeze data, access reports, and create PDFs.
CDMS Clinical Research Coordinator	CDMS Clinical Research Coordinator	Users with the CDMS Clinical Research Coordinator study role can use Vault EDC’s to create Casebooks, fill and submit case report Forms, answer queries, access reports, and create PDFs.
CDMS Data Manager	CDMS Data Manager	Users with the CDMS Data Manager study role can use Vault EDC to perform data management review, view DMR, create PDFs, access reports, and lock data.
CDMS Deployment Administrator	CDMS Deployment Administrator	Users with the CDMS Deployment Administrator role can create new study environments and deploy a study from one environment to another.
CDMS Labs Data Manager	CDMS Labs Data Manager	Users with this role have access to all functions within the Labs tab.
CDMS Lead Data Manager	CDMS Lead Data Manager	Users with this role have the ability to create and close queries, perform DMR, lock data, lock studies and sites, and generate PDFs. They can also 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 Librarian	CDMS Librarian	Users with the CDMS Librarian role can create, manage, and test study designs within library Collections.
CDMS Medical Assessment Editor	CDMS Medical Assessment Editor	Users with this role are able to view and perform clinical assessments and view supplemental data related to those assessments.
CDMS Medical Assessment Reader	CDMS Medical Assessment Reader	Users with this role are able to view clinical assessments and supplemental data related to those assessments.
CDMS Principal Investigator	CDMS Principal Investigator	Users with this role can use Vault EDC to create Casebooks, fill and submit case report Forms, answer queries, access reports, provide signatures, and create PDFs.
CDMS Randomization Manager	CDMS Randomization Manager	Users with this role are able to configure Randomization and manage Randomization Lists.
CDMS Safety Administrator	CDMS Safety Administrator	Users with this role have access to EDC Tools > Safety Configuration to set up the Safety Clinical Data Link in their study.
CDMS Study Designer	CDMS Study Designer	Users with the CDMS Study Designer study role can use Vault EDC Studio to create and design their studies in non-production environments.
CDMS Study Designer Read Only	CDMS Study Designer Read Only	Users with the CDMS Study Designer Read Only study role can access Studio in read-only mode.
CDMS Sub Investigator	CDMS Sub Investigator	Users with the CDMS Sub Investigator study role can use Vault EDC to create Casebooks, fill and submit case report Forms, answer queries, access reports, and create PDFs.
CDMS Super User	CDMS Super User	Users with this study role can access all areas of the application and perform all actions within those areas. This role is only available in non-production environments.
CDMS User Administrator	CDMS User Administrator	Users with this role can manage user accounts and access within Vault CDMS.