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Review and approve ICF tracking log template

The review and approval of an ICF tracking log template is an additional measure to make sure that dedicated personnel reviews and verifies that the template is compliant with protocol requirements and satisfies your study needs. In CTMS, you can specify if the template requires approval when first creating or editing your template.

After you have submitted the ICF tracking log template that requires approval, its status remains Auditing until the assignee approves it.

To review and approve 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 that opens, locate the template that you want to review and select its name.

    Accessing ICF tracking log template to review
    Figure 2. Accessing ICF tracking log template to review

  4. On the page that opens, review the ICF tracking log template form's details. Once reviewed, select Back to Last Page back_arrow_icon.png.

    Selecting to return to ICF templates
    Figure 3. Selecting to return to ICF templates

  5. From the ICF Tracking Log Template List table that opens again, locate the template that you want to approve. Then next to it, in the Action(s) column, select Approve approve_icon.png.

    Approving ICF tracking log template
    Figure 4. Approving ICF tracking log template

    Important

    This option is only visible if you have already submitted the template and you are the assigned personnel to review and approve the submitted template.

  6. In the Approve dialog that appears, enter the comment to follow the approval operation and select save_button.png.

    Entering comment to confirm approval
    Figure 5. Entering comment to confirm approval

Once saved, the ICF tracking log template is approved. You can now activate the template to use in the STUDY MANAGEMENT tab for assigning the template to a study.