Vault EDC for 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.

The topics below will help Lead Data Managers, and users in similar roles, get started using Vault EDC:

Freezing & Locking Data in the Review Tab

During a study, you may need to preserve data in its current state. In Vault EDC, you can freeze or lock data that you need...

Managing Queries in the Review Tab

There are two types of queries in Vault EDC: system and manual queries. Vault generates system queries by running checks on data and creating a...

Managing Study Jobs in the Review Tab

From Review > Study Jobs, you can manage export jobs occurring in your Study from a single location. A job represents a bulk evaluation or...

Working in Vault EDC's Review Tab

Vault EDC provides a specialized area for site monitoring, including queries and DMR/SDV activities, within the Review tab.

Performing SDV & DMR in the Review Tab

Data managers can perform data management review (DMR) to ensure that data collection follows study protocols. Clinical research associates (CRAs) can perform source data verification...

Assessments Administration

Medical monitors and other users in similar roles can perform clinical assessments from within Vault EDC. Before a user can perform a clinical assessment, you...

Managing Casebook Versions

Once a clinical programmer publishes a casebook version in Studio, you can easily manage your casebook versions site-by-site in the EDC Tools > Casebook Versions.

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Comparing Casebook Versions in EDC Tools

You can run a report to show the differences between two Casebook Definitions or two Casebook Definition versions. This illustrates added, removed, and changed design...

Connecting to an FTP Server from EDC Tools

Each vault in your domain has its own FTP server, which supports various features including Vault Loader, Data Export, and the Veeva Vault CTMS integration....

Deleting Study Data in Development & UAT Environments

In development and user acceptance testing (UAT) environments, you can delete all study execution data for a Study or a Site from EDC Tools. This...

About Coder Jobs

From the EDC Tools area, you can manage jobs occurring in your Study. By interacting with these jobs in EDC Tools, you can save time...

About Export Jobs

Vault CDMS includes five (5) jobs for exporting data: Audit Trail Export, Data Listing, Data Export, Code Request Data Extract, and Detail PDFs.

Managing Jobs in EDC Tools

From the EDC Tools area, you can manage jobs occurring in your Study. By interacting with these jobs in EDC Tools, you can save time...

Timezone, Language & Locale Entry Formats

See the tables below for the formatted labels to use when importing users in EDC Tools.

Locking & Unlocking a Study

During the course of your Study, you may need to lock down the entirety of your Study, instead of only an Event or Form. Locking...

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...

Managing Query Rules in EDC Tools

You can manage your query-type Rules from the EDC Tools > Query Rules tab. In the Query Rules tab, you can view details about a...

Assigning Review Plans to Sites

With Targeted SDV (Source Data Verification) and DMR (Data Management Review), your organization can define SDV or DMR requirements for a subject in a Review...

Managing Sites in EDC Tools

Lead Data Managers can now manage their Sites from the EDC Tools area of Vault EDC. In the Sites tab, study administrators can create new...

Managing Study Countries in EDC Tools

You can use the Study Countries tab in EDC Tools to manage the countries within your Study.

Transferring Subjects

Vault EDC allows you to transfer a subject from one Site to another. For example, a subject may relocate and need to switch sites, or...

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...

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...