Vault EDC for Site Users

Pharmaceutical, biotech, medical products companies, and clinical research organizations can better manage their clinical trials using Veeva Vault EDC, a modern, cloud-based electronic data capture solution. Designed to enhance the user experience of every Sponsor, CRO, and Clinical Site user’s experience, Veeva Vault EDC ensures efficient and accurate data collection and management.

Once a study design is deployed, site users can begin collecting study execution data in the Data Entry area. For each Casebook that a data entry user creates, Vault copies all design definitions in the study design into the new Casebook as execution object records.

Impacted Areas

As data entry users complete forms, that data becomes available in the Review area of the application for review by CRAs and Data Managers. At this point, any forms configured for clinical coding also become available in Vault Coder.

Key Features

• Easy Data Entry Interface: During data entry, real-time auto-saving and edit checks increase accuracy and user satisfaction. The breadcrumb navigation reduces time spent navigating between subject casebooks, events, and forms. Personalized user interfaces provide immediate direction of users’ tasks and minimize time spent searching for information. The role-based user interface optimizes the order and structure of data for data entry users to provide the ideal view for their activities.
• Autosave: Vault autosaves data as users enter it.
• Mark as Intentionally Left Blank & Did Not Occur: Users can mark Forms and Items as Intentionally Left Blank and Events as Did Not Occur. With this feature, users can indicate that data was not collected intentionally, so Vault does not create system queries for blank, required data.
• Dynamic Events & Forms: Vault supports the adding and removing of Events and Forms from Casebooks based on user-entered data. Study designers can create Add Event Group, Add Event, and Add Form rules to add them to the Casebook when entered data matches criteria defined in the rule.
• Export Casebooks as PDFs: Users can export Casebooks and Forms as PDFs, both with and without collected data, for documentation and external evaluation purposes. Learn more about PDF export.
• Electronic Signature: Investigators can provide an electronic signature for Forms and Casebooks. Vault eSignature meets the requirements of FDA 21 CFR Part 11. Investigators can sign at the Form, Event, or Casebook (subject) level. Upon any data changes after a signature is applied, Vault invalidates the signature and requires the investigator to sign again. Learn more about eSignatures.