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View and export CRF completion status report

The data capture is the key feature and purpose of the EDC application, and it is very convenient to keep track of the completion status of all the CRFs in the study from a single report.

The CRF Completion Status report displays all the CRFs configured for the study organized by sites, subjects, visits, and statuses. It also shows open or closed queries, CRF reviews, and approvals. The report has additional sections—Report Summary by Subject and Report Summary by Site—that provide the statistics on CRF completion, query management, and data review for each subject or site in the study for more focused analysis.

This report helps study personnel assess the incomplete CRFs and required data collection activities at the upcoming visits and plan accordingly. Also, this report can be used to do the retrospective analysis of the completed forms and their review statuses, proving a convenient and comprehensive tool for data collection management in the study. Use the report online or export it to your computer in the XLSX format to share it with third parties and stakeholders or reenter data into different systems.

To view and export the CRF completion status report

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

  2. On the page that opens, in the left pane, select the CRF Status subtab to expand the list of available reports and select CRF Completion Status.

    Accessing CRF completion status report
    Figure 1. Accessing CRF completion status report

  3. On the CRF Completion Status page that opens, study the report details under the three available tabs as follows.

  4. To export the report as an XLSX file, go to the the report tab whose data you want to extract—CRF Completion Status, Report Summary by Subject, or Report Summary by Site. Then from the workspace toolbar, select Export export_icon.png.

    Selecting option to export CRF completion status data
    Figure 7. Selecting option to export CRF completion status data

  5. In the Export dialog that appears, set the export parameters as explained in the following table.

    Setting report export parameters
    Figure 8. Setting report export parameters

    Element

    Details

    Export all data as Excel

    Select this option to export all the report details disregarding any filtering applied to the report. If cleared, the filtered version is exported.

    This option is available for all report export—CRF Completion Status, Report Summary by Subject, or Report Summary by Site.

    Include the next scheduled visit(s) and cycle visit(s)

    Set as follows:

    • Turn on this toggle to include all the active (initialized) CRFs and all the hidden and not yet initialized CRFs for all scheduled visits and cycle visits whose anchor is completed. However, the CRFs for the unscheduled visits remain excluded from the generated report.

    • Turn off this toggle to exclude hidden and not yet initialized CRFs for all scheduled visits and cycle visits whose anchor visit is completed and generate the report with only active (initialized) CRFs.

    This toggle is only available for the CRF Completion Status report export.

    Exclude forms from inactive visits

    Set as follows:

    • Turn on this toggle to exclude from the exported report the CRFs of the visits that are currently in the Inactive status.

    • Turn off this toggle to include in the exported report the CRFs of the visits that are currently in the Inactive status.

    This toggle is only available for the CRF Completion Status report export and if the Include the next scheduled visit(s) and cycle visit(s) toggle is turned on.

    EXPORT

    Select export_button_white_red.png to proceed with the report file generation.

    CANCEL

    Select cancel_button_white_blue.png to discard the report export.

  6. The downloads widget appears depicting the export progress. Select the widget to access downloadable files.

    Selecting downloads widget for CRF completion status report
    Figure 9. Selecting downloads widget for CRF completion status report

  7. In the My Downloads dialog that appears, go to the Download is Ready tab and next to the generated report, select the download symbol download_icon.png.

    Downloading CRF completion status report
    Figure 10. Downloading CRF completion status report

Once the report details are studied and the exported file downloaded, you have the needed data on your computer and can use it as per your business scenario.

In this section:

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

See also eCRF.

A time span that defines the allowable range for a subject visit in case it is not possible to conduct that visit on the exact scheduled visit date.

An eClinical application that represents unified and configurable subject randomization and trial supply management tool for subject grouping, drug inventories, shipments, and dispensations, as well as other vital processes during a clinical trial.

Get to know all the possibilities of the app with the comprehensive IWRS User Guide.

A person responsible for managing and ensuring the integrity, accuracy, and confidentiality of data collected during clinical trials. The DM’s scope of work might include maintaining the quality of data, complying with regulatory requirements, and supporting the overall success of clinical research.

In the eClinical system, the Data Manager (DM) user role is granted to a person who is mainly responsible for cleaning the data, making sure the data is entered correctly according to all requirements and industry standards, and creating manual queries for clinical research coordinators on any questionable data pieces. Before the study goes live, works with the sponsor and receives and addresses their feedback to set up the study and CRFs in EDC in a way that the sponsor approves.

A person responsible for overseeing and monitoring a clinical trial to ensure it is conducted in compliance with regulatory standards and protocols. The CRA’s scope of work might include protocol review, site selection and initiation, monitoring, data entry control, and more.

In the eClinical system, the Clinical Research Associate (CRA) user role is assigned to a person who works with the sites, and in EDC, mainly has to make sure that the entered data is truthful to the source document. CRA checks the source document in a process called source data verification and ensures that everything entered by the clinical research coordinators is valid to avoid any discrepancies caused by human errors.

A review of data collected via CRFs, especially those related to adverse events and serious adverse events data records. The safety review is intended to identify any risks related to subject safety. This review can be done by physicians, pharmacovigilance teams, or other dedicated personnel as per study protocol.

source data verificationsource data verificationsource data verification

A specific period within the clinical trial during which certain activities or interventions occur. Clinical trials are conducted in multiple phases, each consisting of several cycles, depending on the study design and the specific protocol.

A type of marker for a visit that designates when a specific visit is expected. With a corresponding SD functionality, depending on the anchor assigned to the visit, the visit window with the prescribed activities is calculated.

For example, if the anchor assigned is Initial, the visit is expected to be the first one (considering the Target, Access, and Overdue settings). If the anchor assigned to the Drug Administration visit equals Screening, it means that the Drug Administration visit happens after the Screening visit (considering the Target, Access, and Overdue settings).