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Create new version of ICF tracking log template

When an ICF tracking log template is associated with a study, then you cannot edit or inactivate it, as well as modify its data. Therefore, if, for some reason, you wish to change the data in the template that is assigned to a study, then you can create a new version of the template instead and modify it as required. However, note that the changes you perform to the new version do not affect the version of the template that is assigned to a study. To use the latest template version for a study, upgrade the assigned template version.

To create a new version of 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. From the ICF Tracking Log Template List table, locate the template for which you need to create a new version. Then next to it, in the Action(s) column, select New Version copy_icon.png.

    Selecting to create new version
    Figure 2. Selecting to create new version

    Important

    This option is only available if the template is already used by at least one study in the CTMS application.

  4. In the New Version dialog that appears, add the details as explained in the following table.

    Creating new ICF tracking log template version
    Figure 3. Creating new ICF tracking log template version

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Need Approve

    Configure as follows:

    • Turn the toggle on if you want designated personnel to review and approve the new version of the ICF tracking log template before you can start using it for a study.

    • Turn the toggle off if the new version of the ICF tracking log template does not require approval and can be used in studies right upon creation.

    Approve By*

    If you have turned the Need Approve toggle on, then in this dropdown list, select the user role to whom you want to assign the new version of the protocol deviation template for review and approval.

    Description

    Enter a brief description of the purpose of creating the new version of the ICF tracking log template.

    SAVE

    Select save_button.png to save your changes.

    CANCEL

    Select cancel_button_white_blue.png to discard your changes.

Upon saving, the latest version of the template is created and it appears in the ICF Tracking Log Template List table. You can modify it as required, and submit it to start using it in the STUDY MANAGEMENT tab.

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.