Vault EDC for 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.

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

Answering Queries

Once you have submitted a form, Vault, a Clinical Research Associate (CRA), or a Data Manager may open a query on a value. A query...

Working with Casebooks

Vault EDC uses two objects to manage participants in a study: Subject and Casebook. A Subject record represents an individual subject participating in a Study....

Entering Data

Vault EDC collects data through Forms. Forms are object records that group together Item object records. Each Item record represents an ‘answer,’ or a field...

Using Listing Pages

Vault EDC uses three standard listing pages: Casebook, Site, and Study. All three listing pages are inside the Data Entry tab. After clicking the Data...

Providing an eSignature

You can sign and date in Vault using eSignature. Vault eSignature meets the requirements of FDA 21 CFR Part 11.

Working with Repeating & Common Forms

Repeating forms allow answers to the same set of questions to be captured multiple times. Common forms are forms not associated with a single event,...

About the Task Bar

You can easily manage your tasks, forms, queries, and messages in the task bar. The task bar displays icons to indicate upcoming work and how...

Viewing Audit Events

Vault CDMS automatically collects and records information about any data entry, change, or action taken on any data, including system-generated data. You can view the...

Welcome to Vault EDC

Welcome to Vault CDMS Help! The topics below can help you get started using Vault EDC’s robust clinical data capture capabilities.