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Select ICF tracking log template for study

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.

To select the ICF tracking log template for a study

  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 General Information block, select the template as explained in the following table.

    Selecting ICF tracking log template
    Figure 3. Selecting ICF tracking log template

    Tip

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

    Element

    Details

    ICF Tracking Log Template*

    Select the ICF tracking log template that satisfies your study requirements.

    Current Version*

    Represents the latest version of the selected ICF tracking log template currently available in the system. The field is autofilled by the system, the selection cannot be changed manually.

    SAVE

    Select save_button.png to save the changes.

    Important

    If there already are any ICF tracking log records using the currently selected template, you cannot change the template unless you inactivate or remove the existing records.

    Receiving error on ICF template change
    Figure 4. Receiving error on ICF template change

Once saved, the selection is applied and the ICF tracking log template is associated with the study.

See also
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.