View case details from the Case Series page

When viewing a case series from the Case Series page, you can select a case ID to view case details.

If the Allow Case Comment/Review/Exclusion option is enabled, you can indicate that you have reviewed the case details and provide a comment.

At a minimum, the Case Details page typically includes the following information:

  • Case Information (demographic information)
  • Reported Drugs/Vaccines
  • Reported Events/Symptoms

Additional information includes reported outcomes, case report sources, narrative text, and so on.

If specified by the configuration, a description of the source data appears below the case details. For example: Source Data: AERS data as of 4th quarter 2009 from NTIS Public Release loaded on 2010-04-18.

  1. In the left navigation pane, hover on the Data Analysis icon (Data Analysis icon), then select Case Series.
  2. (Optional) Filter the list as necessary by selecting a project and a configuration from the drop-down menus.
  3. Select the case series' Row Action menu (Row Action menu), and then select View Cases.

    Note:

    Because Oracle Empirica Signal retrieves the data from the source data, it does not include custom terms or values created by data transformations.

    The Cases page lists the cases in the case series in a table. The variable representing the case ID is the first column of the table and is a link to the details of that case. The data configurations associated with the case series determine the additional columns that appear. For example, if the site option All Case Comment/Review/Exclusion is enabled, additional columns indicate whether the case has been reviewed or excluded, and whether comments have been added by a reviewer.

  4. Select a case ID link.
    Oracle Empirica displays the Case Details page. At a minimum, the following information appears:
    • Case information (demographic information)
    • Reported Drugs/Vaccines
    • Reported Events/Symptoms

    There might also be additional information about reported outcomes, case report sources, narrative text, and so on.

    If you have set your user preferences to show a table of contents for case details, there is a Contents section at the top of the page. It includes links that you can select to jump to various types of data on the page.

  5. In the Reviewer Input section at the bottom of the dialog box, you can do the following:
    • To indicate that source data for a case has been reviewed, select Reviewed.
    • If you do not want the case to appear on the Cases page when you hide excluded cases, select Excluded.
    • In the Comments text box, enter comments about the data.

      Note:

      The Reviewer Input section appears only if the appropriate site option has been set.
  6. You can also perform the following actions:
    • To print case details, select the Print link.
    • To download case details to an Excel spreadsheet or a Word Rich Text Format file, select the Download link.
    • To save the case details as an attachment to a topic, select the Save to Topic link (available if the topics feature has been set up).
    • To go to a third-party application showing further information about the case, select the custom link (available only if configured for the data configuration on which the case series is based).
  7. Several buttons provide additional actions:
    • To save your changes and close the Case Details dialog box, select Save.
    • To save your changes and keep the Case Details dialog box open, select Apply.
    • To view the case details for another case in the case series, select Prior or Next.
    These buttons are unavailable for case series that contain 50,000 cases or greater.