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Process 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 create ICSRs using the E2B R3 import by uploading an XML file with your case data or receiving such a file via a gateway. Once the file is imported, its data must be processed for the system to detect the type of XML and extract the information from it.

To process the E2B R3 import data

  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. Based on where your imported file resides, select the Manual Upload or Gateway Received tab.

  4. In the table that appears, locate the unprocessed file and from the Actions column next to it, select Edit pencil_icon.png.

    Tip

    You can see the uploaded files with cases based on the study access permission granted via ADMIN.

    Selecting to edit unprocessed import record
    Figure 2. Selecting to edit unprocessed import record

  5. On the resulting page, from the workspace toolbar, select Process review_icon.png.

    Selecting to process import record
    Figure 3. Selecting to process import record

    Important

    In case the import fails, you receive a respective notification. The possible scenarios for the failure can be:

    • An incorrect form of the XML file: in this case, contact your data provider to obtain a new and corrected file.

    • Inappropriate import format: for instance, E2B R2; the feature only supports XML files in E2B R3 format.

    Troubleshoot your file and repeat the E2B R3 upload procedure.

  6. Upon successful processing, the data from the file is imported and displayed in the newly added form fields and the ICSR table. The details of these data elements are explained in the following table.

    Viewing processed data
    Figure 4. Viewing processed data

    Important

    All the elements presented in the following table are read-only. The values populate from the processed XML file.

    Element

    Details

    Total Number

    Represents the total number of ICSRs in the uploaded XML file.

    The system currently supports importing only one ICSR per single XML file.

    Imported Number

    Represents the number of ICSRs whose data is imported into the system upon processing out of the total number of ICSRs in the uploaded XML file.

    The system currently supports importing only one ICSR per single XML file.

    XML ID and Gateway Routing ID are different?

    Represents whether the XML ID value of the imported file is different from the Gateway routing ID (Yes) or not (No). The option is autoselected based on the system check upon file processing and cannot be manually changed.

    This field is only available for gateway-received files. For manually uploaded files, this value is inapplicable.

    N.1.1 Type of Messages in Batch

    Represents the type of information being transmitted.

    N.1.2 Batch Number

    Represents a unique tracking number assigned by the sender to each outbound ICH ICSR batch file. The batch number is unique only to the sender.

    N.1.3 Batch Sender Identifier

    Represents the origin of the ICSR reports (creator of ICH ICSR batch file), for instance, a company name or regulatory authority. The identifier is unique to the receiver.

    N.1.4 Batch Receiver Identifier

    Represents the intended destination of the ICSR batch file. The identifier is unique to the sender.

    N.1.5 Date of Batch Transmission

    Represents the date when the ICH ICSR batch file was transmitted.

    ICSR

    The table represents general data on the reported case.

    Case Number

    Represents the case number identifier and is only available upon successful import. It is also an active link that opens your case details page in the new browser tab.

    Case Version

    Represents the case version and is only available upon successful import.

    Case Status

    Represents the case status and is only available upon successful import.

    N.2.r.1 Message Identifier

    Represents a unique tracking identifier assigned to a specific ICH ICSR message transmitted by the sender. One ICH ICSR message contains one and only one ICSR.

    N.2.r.2 Message Sender Identifier

    Represents an identification of the sender of the ICSR reports (creator of ICH ICSR message).

    N.2.r.3 Message Receiver Identifier

    Represents an identification of the intended recipient of the transmission of the ICSR message.

    N.2.r.4 Date of Message Creation

    Represents the date when the ICH ICSR message was created in the sender’s database.

    Initial / F-U / Nullification

    Represents if the report is initial (the case is reported for the first time), follow-up (the data in the report is an additional/updated version of the previously reported case), or nullification (the data in the report nullifies the previously reported case that becomes invalid).

    Process Status

    Represents the current processing status of the report, such as Unprocessed, Initial Report, Update Report, Follow-up Report, and Reject Import.

    Warnings / Errors

    Represents any warning or error the system encounters upon processing and validating the report. This is also an active link that you can select to open the dialog with a detailed list of errors encountered by the system.

    Reviewing processing warning
    Figure 5. Reviewing processing warning

    Comment

    Represents any comments added to the report by the user performing the import.

    Case Receipt Date

    Represents the date when the safety department received the most recent case data.

    Case Country

    Represents the country in which the first AE occurred at the time of the initial report.

    Type of Report

    Represents the type of the report: Spontaneous report, Report from study, or Other.

    Worldwide Unique Case ID

    Represents a unique international identifier assigned to the case.

    Product Name

    Represents the medicinal name of the first suspect product for the case.

    Generic Name

    Represents the chemical name of the drug based on the compound's chemical structure.

    The field may remain empty since it only applies to the NMPA E2B R3 XML.

    Event Verbatim

    Represents the original reporter's words or short phrases used to describe the first reported event.

    Event PT Term

    Represents the automatched PT of the first event.

    The field remains empty when automatch fails.

    Event LLT Term

    Represents the automatched LLT of the first event.

    The field remains empty when automatch fails.

    Patient Name or Initials

    Represents the name or initials of the patient for whom the case is reported.

    The field may remain empty since this is an optional element.

    Sponsor Study Number

    Represents the study number assigned by the sponsor.

    The field may remain empty since this is an optional element.

    Subject ID

    Represents the unique identifier of a patient (subject) assigned to them by the sponsor in the course of a clinical trial.

    The field may remain empty since this is an optional element.

    Reporter's Last Name

    Represents the last name of the primary reporter of the case.

    The field may remain empty since this is an optional element.

    Reporter's First Name

    Represents the first name of the primary reporter of the case.

    The field may remain empty since this is an optional element.

    Reporter's Qualification

    Represents the qualification of the primary reporter of the case.

    Reporter's Country

    Represents the two-letter code of the reporter’s country according to ISO 3166-1 (Codes for the representation of names of countries and their subdivisions – Part 1: Country codes).

You have processed the imported E2B R3 file and can now review the resulting ICSR data.

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.

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.

A Chinese national regulatory organization that supervises the safety, registration procedures, and standard management for drugs (including traditional Chinese medicines (TCMs) and ethnomedicine), medical devices, and cosmetics.