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 Tools and create custom study roles from Tools > Role Management.
Accessing Role Management
To access the Role Management area, click the Tools tab in the top navigation bar, and then click Role Management.
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:
- CDMS Assessment Editor: Users with this role are able to view and perform clinical assessments and view supplemental data related to those assessments.
- CDMS Assessment Reader: Users with this role are able to view clinical assessments and supplemental data related to those assessments.
- 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.
- 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.
- 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 study role can create new study environments and deploy a study from one environment to another.
- 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 Principal Investigator: Users with this roles can use Vault EDC to create Casebooks, fill and submit case report Forms, answer queries, access reports, provide signatures, and create PDFs.
- CDMS Study Designer: Users with the CDMS Study Designer study role can use Vault EDC Studio to design their studies.
- 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 User Administrator: Users with this role can manage user accounts and access within Vault CDMS.
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.
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.
Creating & Editing Roles
You can create and edit custom Study Roles from Tools > Role Management. See details here.
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.
You can control access to various application functions from the Functions section of the role table:
You can control access to the following standard tabs from the Standard Tabs section of the role table:
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.
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:
|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