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Complete/Edit ICF tracking record

To track ICF completion for subjects of your study, you need to add ICF tracking records and complete the forms according to the ICF tracking log template selected for the study.

Sometimes, you have insufficient details to complete the added record right away and you want to leave it and return to record completion later. In this section, you can learn how to complete the previously added ICF tracking record with the Initial status or edit the data in those that are already completed.

Important

With the ICF Tracking Log > Write permission granted to your user role in ADMIN, you can complete the initial ICF tracking records added by you. However, with the ICF Tracking Log > Override permission, you can complete the records added by other users and edit those that are already completed, following the same procedure.

To complete or edit an ICF tracking record

  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 page that opens, from the left pane, select ICF > ICF Tracking Log.

  3. In the ICF Tracking Log table that appears, locate the record in the Initial status that you want to complete. Then from the Actions column next to it, select Go go_icon.png.

    Accessing record completion page
    Figure 3. Accessing record completion page

  4. In the form that opens, complete the details according to your study requirements. The form fields depend on the ICF tracking log template selected for your study.

    Completing ICF tracking record form
    Figure 4. Completing ICF tracking record form

    Tip

    If you want to leave the page without saving the changes, the system prompts you with a respective suggestion.

    Confirming to leave page
    Figure 5. Confirming to leave page

  5. Once the form is completed, there are a few actions available to you as explained in the following table.

    Action

    Details

    SAVE

    Select save_button.png to save and submit the completed form.

    Temp Save

    Select temp_save_button.png to save the changes if the form is not entirely completed or requires further details. Thus, the form remains in the Initial status until completed.

    Inactivate

    Select inactivate_button.png to deactivate the ICF tracking record. For deactivation, you must provide the reason.

    Providing deactivation reason
    Figure 6. Providing deactivation reason

    Activate

    Select activate_button.png to activate the previously deactivated ICF tracking record. For activation, you must provide the reason.

    Providing activation reason
    Figure 7. Providing activation reason

Upon saving, the form is submitted and its status becomes Completed.

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.

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.

An eClinical application that represents an administrative system used to manage users, authorities, and sponsors at the company level. It provides studies, sites, and sponsors with high-granularity role-based access management across all eClinical applications.