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 to preserve. Locking or freezing data can be useful before or after data review activities.

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 query when data doesn’t meet specifications defined during study design. For example, Vault creates a system query when an entered date is outside of a certain range. Manual queries are those created by a Clinical Research Associate (CRA) or Data Manager.

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 action upon collected study data. For example, the Data Export job exports selected study data in CSV or SAS format.

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 (SDV) to ensure that any data collected is accurate. SDV involves manually comparing data from the source to data entered into Vault EDC.

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.

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 components. You can also compare two different versions across two different vaults.

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. The FTP server is a temporary storage area for files you’re uploading to or extracting from Vault. For example, when exporting data using a Data Export job, you can choose to export the resulting CSV to your FTP server. From Tools > EDC Tools > FTPs, you can create Connections between your vault’s FTP server and the FTP server of other vaults or external FTP destinations.

Deleting Study Data in Development & UAT Vaults

In development and user acceptance testing (UAT) vaults, you can delete all study execution data for a Study or a Site from EDC Tools. This is useful when your study undergoes multiple rounds of testing. Once your study team finishes testing a certain version of the study design and feels the need to start over with a new iteration of the design, you can delete the underlying data collected for the Study. Then you can use the same Study or Site to test your new design.

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 by reviewing and initiating jobs in from a single location. A job represents a bulk evaluation or action upon collected study data. For example, a Query Rules job evaluates all collected study data against the chosen rule.

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 a Study puts your Study in a read-only state, until you unlock it. You can lock a Study while in progress for interim analysis, safety issues, or if your study is put on hold, or you can lock your Study after data collection is complete.

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 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 rule and activate or inactivate it. From the Jobs tab, you can initiate a job that evaluates user-entered data against one or multiple query-type Rules, without waiting for a data-entry user to complete a Form. You can also choose to preview the results of that job before initiating it.

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 Plan. Targeted SDV and DMR are extremely flexible and support varying review requirements across Items at the Form level. You can also configure Targeted SDV or DMR for some Forms to be very granular, drilling down to a specific Item Group and Item combination.

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 Sites for site personnel to use when conducting the Study.

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 they may want to transfer to a site that is closer to their home or office. From EDC Tools, you can easily move one or more Subjects to a new Site, including all collected data, with a single action.

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.

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.