Skip to main content

Lock/Unlock ICF tracking record

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

You can prevent any actions to the records that, for some reason, must not be changed or removed from the system. For this, you need to lock a specific record.

The locked record cannot be completed, activated/inactivated, or deleted. You can only view record details, review its operation history, or access the audit trail per item. However, once unlocked, all the actions become available again.

To lock or unlock 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, go to the record that you want to activate or inactivate. Then from the Actions column next to it, select More more_icon.png and then one of the following:

    • Lock lock_icon.png: to lock the record and prevent it from amendments or any interactions.

      Locking ICF tracking log record
      Figure 3. Locking ICF tracking log record

      Important

      Once the record is locked, the ICF listing record associated with it becomes unavailable for editing and deletion.

    • Unlock unlock_icon.png: to unlock the record and allow amendments and other interactions.

      Unlocking ICF tracking log record
      Figure 4. Unlocking ICF tracking log record

      Important

      Once the record is unlocked, the ICF listing record associated with it becomes available for editing and deletion.

Based on the performed action, you have locked or unlocked the ICF tracking record.

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.