Skip to main content

Export ICF tracking log template

In CTMS, you can create a library of ICF tracking log templates that can be reused throughout your studies.

The export feature is most useful when you need to extract the configured template from the system to further import it into another one or share the template with third parties who have no access to CTMS.

The most common scenario is when, for instance, a clinical research associate (CRA) creates a template in the UAT lifecycle to test, adjust, and validate it. Then the validated template can be exported from UAT and imported to PROD.

To export an ICF tracking log template

  1. In the CTMS application header, select the LIBRARY tab.

  2. On the page that opens, from the left pane, select ICF Tracking Log Template.

    Accessing ICF tracking log template subtab
    Figure 1. Accessing ICF tracking log template subtab

  3. In the ICF Tracking Log Template List table that appears, select the checkbox(es) next to the template(s) you want to export. Then from the workspace toolbar, select Export export_icon.png.

    Exporting ICF tracking log template file
    Figure 2. Exporting ICF tracking log template file

  4. In the dialog that appears, select the data export option as needed:

    • Export current version as Config: to extract a CONFIG file with configurations of the currently effective template version and use this file to import and set up a template in another study.

    • Export current version as PDF: to extract a PDF file with the currently effective template version details.

    • Export all version as PDF: to extract a ZIP folder with the current and all the historical versions of the template, each as a separate PDF file.

    Selecting export option
    Figure 3. Selecting export option

  5. Select export_button_white_red.png and in the downloads widget that appears, view your download progress. Select the widget to open the My Downloads dialog.

    Downloads widget for ICF tracking log template
    Figure 4. Downloads widget for ICF tracking log template

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

    • Preparing: lists all the files whose export is in progress, and they are not yet ready for download. Wait until the needed file moves to the Download is Ready tab.

    • Download is Ready: lists the files whose export is complete, and they can be downloaded to your computer by selecting download_icon.png.

    Downloading extracted ICF tracking log template data
    Figure 5. Downloading extracted ICF tracking log template data

The ICF tracking log template now becomes available on your computer as .config files and can be managed offline as needed.

In this section:

A document used to track the distribution, collection, and status of Informed Consent Forms (ICFs) from participants in the trial. It is a management tool that ensures proper documentation and completion of all steps related to informed consent throughout the trial process.

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.