Skip to main content

Upload E2B R3 import file

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 manually upload an E2B R3 file in XML format to import your case data and create an ICSR based on it.

To upload the E2B R3 import file

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

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

  3. Under the Manual Upload tab that opens, from the workspace toolbar, select New add_new_icon.png.

    Adding new E2B R3 import
    Figure 1. Adding new E2B R3 import

  4. On the resulting page, upload the file and complete the configurations as explained in the following table.

    Uploading and configuring E2B R3 import
    Figure 2. Uploading and configuring E2B R3 import

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    E2B XML Source

    Represents the method of how the import file is acquired by the system. This is a read-only field and Manual Upload is the default value.

    Import Status

    Represents the current status of the import file. The default value is Not Processed and as the import file passes through its lifecycle, the status changes automatically to the appropriate one: Processed Success, Processed Failed, Complete Import, Partial Import, and Reject Import. The status cannot be amended manually.

    E2B File*

    Select Upload File upload_icon.png and follow the prompts to select and upload the E2B R3 import file. Only the XML file format is supported. You can only upload one ICSR via a single XML E2B R3 file import.

    Approved Trading Partner*

    • Yes: select this option for the system to check if the XML file contains sender ID and Receiver ID values in its submission configurations. If selected and the file does not have the stated details, the system prompts you with a respective error message upon saving.

    • No: select this option if you do not need to check if the XML file contains sender ID and Receiver ID values in its submission configurations. If selected, you can save your uploaded file disregarding if it has the stated details.

    Using XML Received Date?*

    • Yes: select this option if you want to use the data from the uploaded file to fill the dates of acquiring the safety data.

    • No: select this option if you want to manually specify the dates of acquiring the safety data via the Latest Received Date and Safety Received Date fields.

    Latest Received Date

    Select the date to specify when the latest version of the AE/SAE case data reported in your file has been received.

    This field is only available if the Using XML Received Date? value is No.

    Safety Received Date

    Select the date to specify when the safety department first received the AE/SAE case reported in your file.

    This field is only available if the Using XML Received Date? value is No.

    MedDRA Version*

    Select the MedDRA version according to customer migration requirements. Usually, the latest current version of the dictionary is used.

    Case Language*

    Select the language of the case report according to customer migration requirements.

    SAVE

    Select diskette_icon.png to save the implemented changes and complete the file upload.

Once saved, the E2B R3 import file is uploaded and can now be processed.

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 internationally used set of terms relating to medical conditions, medicines, and medical devices created to assist regulators with sharing information.