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Contact log

In PV, Contact Log serves as a repository of all communications, including the follow-up queries and case notes, within the same ICSR version. With this functionality, you can have controlled and traceable communication between PV users, as well as between PV and EDC users involved in the ICSR management.

Important

Access to contact log records—queries and case notes—is based on the study access permission granted via ADMIN.

The communication tools of the contact log are the following:

  • Follow-up query: use this tool to request fixes, clarifications, or other assistance from the EDC user who submitted the ICSR case.

    Important

    Follow-up queries can be created only for the cases created via the EDC import.

  • Case note: use this tool to add notes to specific ICSR forms or particular fields for other users' attention.

In this section:

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 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.

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.