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Upgrade ICF tracking log template version

ICF tracking log is a functionality 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.

To configure proper tracking of ICF completion, you need to select one of the previously configured ICF tracking log templates to associate it with your study.

However, if a new version of the ICF tracking template is created in CTMS, it is not assigned to your study automatically to avoid versioning conflicts. If the changes in the ICF tracking template are suitable for your study, you can upgrade to the latest version manually.

To upgrade the ICF tracking log template version

  1. Access the study management page in one of the following ways:

    • In the CTMS application header, select the DASHBOARD tab and then select the study dashboard of your interest.

      Accessing study management from dashboard
      Figure 1. Accessing study management from dashboard

    • In the CTMS application header, select the STUDY MANAGEMENT tab. Then from the Study Data List table, select the study name of your interest.

      Accessing study management from study data list
      Figure 2. Accessing study management from study data list

  2. On the study management page that opens, from the left pane, select ICF > ICF Tracking Log Setting.

  3. On the ICF Tracking Log Setting page that opens, from the workspace toolbar, select Upgrade Version upgrade_version_icon.png.

    Upgrading ICF tracking log template version
    Figure 3. Upgrading ICF tracking log template version

    Tip

    The Upgrade Version upgrade_version_icon.png option is unavailable if there are no newer versions than the current one for the selected ICF tracking log template.

  4. In the Upgrade Version dialog that opens, review the details and confirm your action as explained in the following table.

    Upgrading ICF tracking log template version
    Figure 4. Upgrading ICF tracking log template version

    Element

    Details

    ICF Tracking Log Template

    Represents the name of the template associated with the ICF tracking log for the study.

    Current Version

    Represents the currently used version of the template associated with the ICF tracking log for the study.

    Upgrade Version to

    Represents the latest version available for the upgrade of the template associated with the ICF tracking log for the study.

    CONFIRM

    Select confirm_button_red_white.png to proceed with your action.

    CANCEL

    Select cancel_button_white_blue.png to discard the version change.

Once confirmed, the ICF tracking log template is upgraded to the latest version.

In this section:

A document that provides essential information about a clinical trial to potential participants to ensure their complete understanding of the research nature, the risks and potential benefits involved, and their rights as participants.

Before enrolling in a clinical trial, participants must read and understand the information in the ICF, and signing the ICF indicates their willingness to participate, understanding that they have been fully informed about the study.