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.
EDC has many unique capabilities and configurations to capture clinical data:
Casebooks: Vault EDC uses casebooks to house all data related to a specific subject in a study. Casebooks display a schedule of all study events for a subject and contain all forms for that subject. Vault EDC’s casebooks include the casebook schedule: this is a clickable event timeline, which can expand to show all forms for an event.
System & Manual Queries: Vault EDC includes both system- and manually-created queries. Queries provide traceability, including an item-level audit trail, comments, and status indicators.
Task Bar: You can use Vault EDC’s task bar to quickly view any tasks assigned to you, such as open queries and overdue forms. You can filter the task bar by subject. The task bar includes important task details and links to the area in Vault EDC where you can complete a task.
Source Data Review & Verification: Clinical Research Associates (CRAs) can perform source data review and verification tasks with a single click in Vault EDC. Vault EDC includes status indicators to easily show source data review or verification status.
Data Freeze & Lock: Site monitoring and data management teams can preserve data at any given point during a study using either data freeze or data lock. Data freezing preserves data, but it still allows additional actions like source document review or querying to take place. Data locking prevents any modification or action upon data.
EDC Studio: Vault EDC Studio provides organizations with a simple interface for creating study objects, scheduling events, and designing forms for an endpoint-driven study design. With easy editing and casebook versioning, Studio supports flexible study development. Clinical programmers can implement data validation rules in their studies from within Studio to enforce standards and streamline clinical monitoring.
Key EDC Objects
Vault EDC has several application specific objects to house data. Below are some of the key objects available for use in V17R1.
- Study Country
- Event Group
- Item Group