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Export SDV result

Source Data Verification (SDV) involves the review and comparison of data recorded in the source documents such as laboratory results, medical history, adverse event records, and so on against the data captured on the case report forms (CRFs).

Once you have selected the SDV type for your study and configured either global, general, or target SDV settings, the planning stage may be considered complete. You can now start to verify the CRF data against the source documentation and then track the outcomes under the SDV Result tab. For your convenience, you can also export the entire SDV result report from EDC and save it to your computer as an XLSX file.

To export the SDV result report
  1. In the EDC application header, select the STUDY INFO tab.

  2. In the left pane of the page that opens, expand SDV and select the SDV Result tab.

  3. From the workspace toolbar of the SDV Result page that opens, select Export export_icon.png and then one of the available options as follows.

    Exporting data
    Figure 1. Exporting data

    • Export all data as Excel: select this option to export the entire report data regardless of any filtering currently applied.

    • Export filtered data as Excel: select this option to open the Export dialog and set selective filters as explained in the following table.

      Selecting export filters
      Figure 2. Selecting export filters

      Tip

      You can select one or more filters to combine selective parameters for report sorting.

      Element

      Details

      Site Code

      Select the code of the site for which you want to export the SDV result report.

      Subject ID

      Select the ID of the subject for whom you want to export the SDV result report.

      Phase

      Select the subject phase for which you want to export the SDV result report.

      Visit Name

      Select the name of the visit for which you want to export the SDV result report.

      EXPORT

      Select export_button_white_red.png to apply set filters and export the report.

      CANCEL

      Select cancel_button_white_blue.png to discard the changes and close the dialog.

  4. Once exported, the widget appears displaying your download progress. Select the widget to open the My Downloads dialog.

    Downloads widget
    Figure 3. Downloads widget

  5. 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 4. Viewing downloads

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

Once downloaded and saved, the SDV result report—filtered or complete—is available on your computer. For your convenience, in a filtered XLSX report, you can find the applied filter conditions under the Index sheet.

Reviewing filter conditions in exported XLSX
Figure 5. Reviewing filter conditions in exported XLSX

Download SDV result file from export history

Source Data Verification (SDV) involves the review and comparison of data recorded in the source documents such as laboratory results, medical history, adverse event records, and so on against the data captured on the case report forms (CRFs).

Once you have selected the SDV type for your study and configured either global, general, or target SDV settings, the planning stage may be considered complete. You can now start to verify the CRF data against the source documentation and then track the outcomes under the SDV Result tab.

In EDC, the entire SDV result report can be exported from EDC and saved to your computer as an XLSX file. All the previously exported files are stored in the export history, so you can download any previous version of it if needed.

To download the SDV result file from the export history
  1. In the EDC application header, select the STUDY INFO tab.

  2. In the left pane of the page that opens, expand SDV and select the SDV Result tab.

  3. From the workspace toolbar of the SDV Result page that opens, select History history_icon.png.

    Accessing export history
    Figure 1. Accessing export history

  4. In the Export History dialog that appears, view the complete record of previously generated files and next to the one(s) you want to download, select Export download_icon.png.

    Downloading file from export history
    Figure 2. Downloading file from export history

    Tip

    For your convenience, if any report is exported as filtered data, you can find the applied sorting details under the Filter Conditions column.

Once downloaded and saved, the SDV result report is available on your computer. Select ok_button_red_white.png to close the dialog.