A CRA creates a custom report on subject statuses

A Clinical Research Associate (CRA) creates a custom report to view and export data related to subject statuses across studies.

Subject Status Export

Let's go through the required steps to create a custom tabular report with data related to subject statuses within a study in Oracle Clinical One Platform. The purpose of this custom report is to collect detailed and current data related to the statuses subjects have in a study.

To create this or any other report, you must have authoring access to Oracle Clinical One Analytics. See About your access to Oracle Clinical One Analytics.

  1. Select a dataset to work with.

    For the purpose of this use case, select the Subject dataset.

  2. From the Data Elements pane, expand the following folders and then drag and drop the following elements at the top of the canvas, to use them as filters for your custom report.
    Folder to expand Data element to use Additional instructions
    Study STUDY_ID_NAME In the filter dialog, select the studies you want to use to filter out the data on subject statuses from Oracle Clinical One Platform
    Site SITE_ID_NAME Drag the data element onto the empty canvas.
    Subject SUBJECT_NUMBER In the filter dialog, select the subject numbers you want to use to filter out the data.
    Audit IS_CURRENT In the filter dialog, select Y if you want to only include currently opened queries or N, if you want to include all opened queries to ever be raised at in a study.
  3. From the Data Elements pane, continue dragging and dropping the following data elements onto the Rows section in the Grammar Panel.
    Folder to expand Data element to use Additional instructions
    Study
    • STUDY_ID_NAME
    • STUDY_PHASE
    • THERAPEUTIC_AREA
    N/A
    Site
    • ADDRESS_COUNTRY
    • SITE_ID_NAME
    N/A
    Subject
    • SUBJECT_NUMBER
    • STATE
    • STATE_DATE
    N/A
  4. In the upper right corner, click the Share icon and then click File.
  5. On the File dialog, fill-in the following fields, and click Save:
    Field Description
    Name Enter a name for your custom report. For the purpose of this exercise, enter Subject Status Export.
    Format Choose the appropriate format for exporting this custom report. For the purpose of this exercise, because this custom report contains graphics, you can select either CSV or Acrobat (PDF).
    Include Choose either Active Canvas or All Canvas.
    Size Choose the appropriate format size for your report.
    Orientation Choose either Landscape or Portrait.