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Export raw data report

The Raw Data report is designed to display all the study data variables and their values collected via the case report forms (CRFs). The report only shows the data from the submitted CRFs, meaning that the report does not account for the data from the forms that are saved as drafts and not yet finalized. This ensures data clarity as it prevents displaying temporary data entries that can be changed or removed upon actual form submission. This exhaustive report can be a complete source of information on the study data. Thus, you can export the report to set up SAS listings or to reenter the data in another system.

Tip

If you generate and export the report but do not have permission granted to your user role to see some blinded data, the respective values are displayed as blank in the system and the exported file.

To export a raw data report

  1. In the EDC application header, select the REPORTS tab.

  2. On the page that opens, in the left pane, select the Data Summary subtab to expand the list of available reports and select Raw Data.

    Accessing raw data report
    Figure 1. Accessing raw data report

  3. On the Patient Data Listing page that opens, from the Domain dropdown menu, select the domain name to generate your report. You can also sort the report by date or enable filters to get more detail-oriented data.

    Important

    For blinded users, the domains containing all blinded form data do not appear in the Domain dropdown list.

    For the LB (lab data) domain, it is possible to configure the lab data conversion settings.

    Sorting report data by domain, date, and filters
    Figure 2. Sorting report data by domain, date, and filters

    Tip

    You can save custom filter sets for future use by applying filters and selecting Save Filters diskette_icon.png. To access the custom filter sets, select Filter filter_icon_2.png and from the My Filters list that appears, select the previously saved configuration.

    Accessing custom filter sets
    Figure 3. Accessing custom filter sets

  4. Once the report values are filtered according to your needs, from the workspace toolbar, select Export export_icon.png and then the Export Raw Data option.

    Selecting raw data export options
    Figure 4. Selecting raw data export options

  5. In the Export Raw Data dialog that opens, select one of the following options to export the report:

    • All: select CSV or SAS format to export the entire Raw Data report data.

    • Filtered: select CSV or SAS format to export the selective Raw Data report data after filtering is applied.

    • Incremental Since Last Run based on LRMODDTS column: select CSV or SAS format to export the incremental—updated or added—data for the period since the latest (previous) generation of the data change report. With this option, instead of exporting the entire raw data report for a specific period, you can export only new or modified records.

    • Incremental Since Cut-off Date based on LRMODDTS column: select CSV or SAS format to export the incremental data collected after the custom date that you can manually specify using date and time pickers.

    Selecting raw data exporting options
    Figure 5. Selecting raw data exporting options

  6. Once the selection is made, the export is initiated and the download widget and a progress bar appear. Select the widget to open the My Downloads dialog.

    Viewing downloads widget and progress bar
    Figure 6. Viewing downloads widget and progress bar

  7. In the My Downloads dialog that opens, you can find the following tabs:

    • Preparing: under this tab, you can find all the files whose export is in progress, and they are not yet ready for download.

    • Download is Ready: under this tab, you can find all the files whose export is complete, and they can be downloaded to your computer.

    Viewing downloads
    Figure 7. Viewing downloads

  8. Under the Download is Ready tab, next to the file that you want to download, select download_icon.png.

Once the report is exported and saved, you can use its data according to your business needs.

See also
In this section:

An individual piece of data collected within a domain. It represents a specific attribute or characteristic that can vary among subjects in a study. Each variable is defined by its format (such as categorical, continuous, and so on) and plays a crucial role in data analysis, allowing researchers to assess relationships and outcomes in the study.

For instance, within the "Demographics" domain, variables might include "Age," "Gender," and "Ethnicity."

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.

A biostatistical tool used to manage and generate tables, listings, and graphs for clinical study reports and other purposes.