Vault EDC by Application Role

What features and functions are available to you in Vault EDC varies by your application role. If you don’t know which role you have in Vault, check with your study administrator.

The role descriptions below include the security settings for vaults that have the Role by Study feature enabled. Contact Veeva Support to enable this feature in your vault. See Study Access in Vault CDMS for a table mapping these permissions to those in vaults where Role by Study is not enabled.

Assessment Editors

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

Assessment Readers

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

CRAs

Users with the Data Review security profile and the CDMS Clinical Research Associate application role can use Vault EDC to perform SDV, close queries, freeze data, access reports, and create PDFs.

CRCs

Users with the Data Entry security profile and the CDMS Clinical Research Coordinator application role can use Vault EDC's to create Casebooks, fill and submit case report Forms, answer queries, access reports, and create PDFs.

Data Managers

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

Deployment Administrators

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

Investigators

Users with the Data Entry security profile and the CDMS Principal Investigator or CDMS Sub Investigator application roles can use Vault EDC's to create Casebooks, fill and submit case report Forms, answer queries, access reports, provide signatures, and create PDFs.

Lead Data Managers

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.

Reviewers

Users with the Read Only security profile have read-only access to Vault EDC and can generate PDFs.

Study Designers

Users with the Design security profile and the CDMS Study Designer application role can use Vault EDC Studio to design their studies.

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.