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Safety query management in EDC

A safety query is a communication tool for PV users that facilitates requesting data clarifications, confirmation, fixes, or other assistance from the EDC users who are the reporters of the ICSR in question.

Important

Only the user who has generated the data extraction task and sent the data to PV is the recipient of all queries about this case report. This user will be notified of the new incoming queries via email assigned to their user account via the ADMIN application.

In EDC, the queries can be managed via the Safety Queries module, where you can find two tabs, as follows:

Safety Queries module in EDC
Figure 1. Safety Queries module in EDC

  • Open: features all the queries received from PV that have not been reviewed by assignees in EDC or that have been reviewed in EDC but not yet closed in PV.

  • Closed: features all the queries received from PV that have been reviewed by assignees in EDC and closed in PV.

See also
In this section:

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.

A safety service document that includes information required for reporting the adverse events and problems related to products and complaints filed by consumers with respect to any product.

An eClinical application that represents an administrative system used to manage users, authorities, and sponsors at the company level. It provides studies, sites, and sponsors with high-granularity role-based access management across all eClinical applications.