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Review temporal summary of medical data

The Temporal View page provides a summary and event assessment in a timeline format. You can choose which data to include in the event assessment section according to your needs and preferences.

Important

All fields of the Temporal View page are read-only. Any necessary edits must be made in the respective case forms.

To review a temporal summary of ICSR

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

  2. On the ICSR List page that opens, in the table, locate the ICSR record for which you want to review medical data. Then select its case number to open the details page in the new browser tab.

    Alternatively, from the Actions column next to your ICSR, select Edit pencil_icon.png to open the ICSR details in the same browser tab.

    Selecting to edit ICSR
    Figure 1. Selecting to edit ICSR

  3. On the ICSR form page that opens, from the workspace toolbar, select Medical Review medical_review_icon.png.

    Medical Review option
    Figure 2. Medical Review option

  4. On the page that opens, select the Temporal View tab to view and manage the data as explained in the following table.

    Reviewing temporal medical data
    Figure 3. Reviewing temporal medical data

    Element

    Details

    Summary

    The data is pulled from various forms of your ICSR.

    Select arrow_fold_icon.png or arrow_unfold_icon.png next to the block title to collapse or expand the block contents for a convenient form view.

    First Suspect Product

    Represents the first suspect product record.

    Generic Name

    Represents the official name of the active pharmaceutical ingredient of the first suspect product.

    Primary Indication(PT/Verbatim Term)

    Represents the first indication record for the first suspect product.

    Sex

    Represents the sex of the patient for whom the case is registered.

    Date of Birth

    Represents patients' date of birth for whom the case is registered.

    Age

    Represents the age of the patient for whom the case is registered.

    Type of Report

    Represents the type of the ICSR, which can be Report from study, Spontaneous report, and so on.

    Primary Reporter Qualification

    Represents the record of the reporter who is the primary source for regulatory purposes.

    Case Serious

    Represents if the case is serious.

    The rule is that if at least one event reported for the case is serious, the case is considered serious.

    Case Causality

    Represents the case-level causality.

    Event Assessment Display Options

    Select arrow_fold_icon.png or arrow_unfold_icon.png next to the block title to collapse or expand the selectable options and only view the timeline table.

    Suspect Products

    Select or clear this checkbox to show or hide the suspected product in the timeline table.

    Concomitant Products

    Select or clear this checkbox to show or hide the concomitant product in the timeline table.

    Patient Medical History

    Select or clear this checkbox to show or hide the patient medical history in the timeline table.

    Patient Drug History

    Select or clear this checkbox to show or hide the patient drug history in the timeline table.

    Lab Test

    Select or clear this checkbox to show or hide the laboratory tests in the timeline table.

    Events

    Select or clear this checkbox to show or hide the events in the timeline table.

    If selected, you can also chose what events statistics you want to review:

    • All Events: select this option to show the data for all the events reported for the case.

    • Serious Events Only: select this option to show the data for only the serious events reported for the case.

    ID

    Represents the ID of the selected entity.

    Info

    Select View info_icon.png to open the details for the selected entity (product, event, and so on).

    Viewing details for event
    Figure 4. Viewing details for event

    Item

    Represents the selected entity (product, event, and so on).

    Start

    Represents the date of the timeline start for the selected entity.

    Stop

    Represents the date of the timeline end for the selected entity.

    Duration

    Represents the duration of the selected entity timeline.

    Workspace toolbar

    Translation View

    Select bilingual_view_icon_gray.png to review the translated version of the temporal medical data. From the field that appears, select the target translation language.

    Selecting language of translation view
    Figure 5. Selecting language of translation view

    Currently, only English and Chinese translation languages are supported in PV.

    You can go back to the original language view by selecting Translation View bilingual_view_icon_red.png.

    Return

    Select return_route_icon.png to return the ICSR workflow route.

    Forward

    Select forward_route_icon.png to forward the ICSR workflow route.

    CIOMS-I Export

    Select More more_icon.png > CIOMS-I Export export_icon.png to export a draft CIOMS-1 report only to check the case assessments and entries easily following the CIOMS-1 template as we proceed with case processing and review. The exported file has the Draft watermark.

    Exporting draft CIOMS-I report
    Figure 6. Exporting draft CIOMS-I report

    Learn more about the CIOMS-I export functionality in the Export CIOMS-I report section.

    MedWatch3500A Export

    Select More more_icon.png > MedWatch3500A Export export_icon.png to export a draft MedWatch 3500A report only to check the case assessments and entries easily following the MedWatch 3500A template as we proceed with case processing and review. The exported file has the Draft watermark.

    Exporting draft MedWatch 3500A report
    Figure 7. Exporting draft MedWatch 3500A report

    Learn more about the MedWatch 3500A export functionality in the Export MedWatch 3500A report section.

    Back to List

    Select arrow_left_icon.png to exit the medical review and return to the ICSR details page.

You have reviewed the temporal medical summary for your ICSR.

In this section: