Skip to main content

Query administration

In the context of CRF design, a query refers to a formal request or notification raised by the study team regarding a specific data-related concern or discrepancy. Queries are used to flag issues or uncertainties that may impact the accuracy, completeness, or compliance of data that is to be collected via EDC.

In the Study Designer application, while the study team configures the forms, if they encounter inconsistencies or data-related questions, they can create queries to draw attention to these issues and seek clarification or resolution from fellow team members or a sponsor.

Queries in Study Designer
Figure 1. Queries in Study Designer

When managing queries in Study Designer, you can perform the following actions with them:

In this section:

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.

An eClinical application that is mainly used to collect and manage subject data during clinical trials. It integrates with the Study Designer (SD) application and uses preconfigured there case report forms (CRFs) to complete data collection and management. It also provides an audit trail, data alert, source data verification (SDV), payment management, adjudication, and other functions as well as supports data export according to the CDISC ODM standard.

Get to know all the possibilities of the app with the comprehensive EDC User Guide.

Any person, company, institution, group, or organization that is a client of EDETEK and a user of the eClinical system.

In the eClinical system, the Sponsor role is assigned to the user who oversees or pays for a clinical trial and collects and analyzes the data. Before the study goes live, the Sponsor users work closely with the data managers, configuring CRFs and other aspects to make sure everything meets their requirements before giving the green light for the study to go live. In the course of a trial, the Sponsor users make requests for amendments in the system according to a new protocol version, changes in business requirements, or other needs.