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 indicates that a value may be incorrect or require further explanation.

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. That subject’s Casebook object contains all other records related to the Subject for that 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 and value on the Form.

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 Entry tab, which listing page appears first depends on how many studies and sites you have access to. The Studies and Sites listings pages include all Study and Study Site records you have access to. If you have access to more than one study, you’ll see the Study listing page under the Data Entry tab. You can then click into a Study or use the breadcrumb menu to enter the Site listing page, and then click on a Site to open the Casebook listing page.

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, instead spanning across all study events. For example, the Concomitant Medication form may be a common form.

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 close you are to a due date. Depending on your security profile, the task bar displays some or all of the tasks described below.

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 details of who, what, why, and when updates to any electronic record was made. Each audit entry includes the timestamp, user name, affected object, and a description of the event.

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.