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Receive E2B R3 file via gateway

By implementing the E2B R3 standard, the PV system enhances the quality and accuracy of adverse event (AE) data by ensuring consistency, quality, and compliance with regulatory requirements.

In PV, you can receive E2B R3 XML files via a gateway to import your case data and create ICSRs based on them. This feature is used to automatically receive E2B R3 files directly from senders with no need for manual file upload.

Important

To receive files from a certain sender, you need to have the submission setting configured for them in PV. The details of the submission configuration you can request from the EDETEK administrator.

To receive E2B R3 files via the gateway

  1. In the PV application header, select the INTAKE tab.

  2. On the page that opens, from the left pane, select E2B R3 Import.

    Accessing E2B R3 import
    Figure 1. Accessing E2B R3 import

  3. In the contents panel, select the Gateway Received tab.

  4. From the workspace toolbar of the Gateway Received table, select Receive ICSR receive_file_icon.png.

    Receiving new E2B R3 files
    Figure 2. Receiving new E2B R3 files

Once selected, the system updates the list of import files and pulls new ones—if any—from the sender. The cases imported are based on your study access permissions granted via ADMIN. You can now process your imported files.

In this section:

An ICH standard that is used for the electronic transmission of the adverse event information to ensure the efficacy of the clinical trial. The standard is used by the PV application.

Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

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.