Vault EDC for Clinical Research Associates

Users with the Data Review security profile and the CDMS Clinical Research Associate application role can use Vault EDC to perform SDV, close queries, freeze data, access reports, and create PDFs.

The topics below will help CRAs, 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.

Freezing & Locking Data in the Data Entry 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.

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 Data Entry 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 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 Data Entry Tab

Data managers can perform data management review (DMR) to ensure that data collection follows study protocols. Source data verification (SDV) is to ensure that any data collected is accurate. SDV involves manually comparing the data value on a source data to data entered into Vault EDC.

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.

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.