Vault CDMS for User Administrators

Users with the User Administration security profile and the CDMS User Administrator application role can manage user accounts and access within Vault CDMS.

The topics below will help User Administrators, and users in similar roles, get started using Vault EDCCoder:

Managing a Study in EDC Tools

Vault EDC includes a study administration tool within Tools > EDC Tools. You can perform study administration tasks from the EDC Tools area, such as scheduling recurring jobs or controlling user access. Performing tasks and viewing data in a single location saves you time. Tasks in this area apply at the study- and site-level, instead of at the casebook-level or lower, such as those tasks in the Actions menu or task bar.

Managing Study User Access in EDC Tools

This article describes how to manage an EDC user’s access to Studies and study-related data.

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.

Vault Coder Security Profiles

In Vault, each user has an assigned license type and security profile. Each security profile has one or more permission sets. The license type, either Full User or Read-only User  is the first level of access control that vault applies to a user. Permission sets, applied through the user’s security profile, are the second level of access control. Both the license type and permission set must grant access to a user in order for that user to access the functionality.

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.

Vault EDC Security Profiles

In Vault, each user has an assigned license type and security profile. Each security profile has one or more permission sets. The license type, either Full User or Read-only User  is the first level of access control that vault applies to a user. Permission sets, applied through the user’s security profile, are the second level of access control. Both the license type and permission set must grant access to a user in order for that user to access the functionality.

Study Access in Vault CDMS

Vault CDMS leverages the Vault Platform to control user access. In addition to configuring account-level access, User Administrators can manage user access at the Study level.