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Clinical Data (Report)
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    Clinical Data (Report)

    Owned by Toma Holtzer
    Last updated: 29-Mar-2025
    4 min read

    Filters

    • Subjects - select one or more Subjects from the dropdown. If no Subjects are selected, the report will be generated for all Subjects who have an active Cohort Assignment on the Study.

    • Study Events - select one or more Study Events from the dropdown. If no Study Events are selected, the report will be generated for all Study Events from the CRF Design > Study Library > Study Events.

    • Form(s) - select one or more Forms from the dropdown. If no Forms are selected, the report will be generated for all Forms from the CRF Design > Study Library > Forms Library.

    • Data Status - default filter selection is Data in All Statuses, but you can restrict the output to show only Data with a specific Data Status (Nonconformant, Incomplete, Unsaved, Complete).

    • Output Type - you can generate the report in Excel or CSV format.

    image-20250215-212412.png

    Output

    Tabs

    Each tab in the report represents an Item Group from the CRF Design > Study Library > Item Group Library.

    Columns

    • Study - Study Name from Study > Configure > Basics

    image-20250215-212755.png

    • Site - if Site OID is specified on Study Site Basics page, this displays the Site OID. If not Site OID is specified, then this displays the Site Name.

    image-20250215-213408.png
    image-20250215-213504.png

    • Subject - displays the concatenation of Subject Numbers from the Study.

    image-20250215-213633.png

    • Epoch - displays the name of the Epoch that the data was captured for.

    image-20250215-213731.png

    • Cohort - displays the name of the Cohort for which the data was captured.

    image-20250215-213834.png

    • Study Event - displays the Study Event for which the data was captured.

    image-20250215-213937.png

    • Form - displays the Form in which the data was captured.

    image-20250215-214105.png

    • Form Status - displays the Form Status.

    • Timepoint - displays the Timepoint, if it is a timed Scheduled Activity.

    image-20250216-173807.png

    • Scheduled Time - displays the Scheduled Time, based on the Initial Reference Time set at the Cohort Assignment level (only applies to timed Scheduled Activities).

    image-20250216-175452.png

    • Item Group - displays the Item Group Name.

    • Item Group Status - displays the Item Group Status.

    • Collection Time - displays the initial collection time.

    • Deviation Seconds - displays the number of Seconds by which the Data Collection was performed too early (negative value with -) or too late.

    • Deviation Windows (Seconds) - displays the Deviation Windows that were set during Study Design.

    • Last Transaction Time - displays the last time the Item or Item Group was updated.

    • Data Review Status per Reviewer - the column name specifies the full name of the Reviewer, the column value will be empty if there was no review, or date and time of when the review was performed.

      image-20250216-175835.png

     

    For each Item in the Item Group a set of columns, as follows:

    Item Name - displays the Item Name.

    Item Origin - displays the Origin - CRF or Protocol - as defined during Study Design.

    Status - displays the Status of the Item.

     

     

     

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