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Export ICF tracking log template

In CTMS, you can create a library of ICF tracking log templates that can be reused throughout your studies.

The export feature is most useful when you need to extract the configured template from the system to further import it into another one or share the template with third parties who have no access to CTMS.

The most common scenario is when, for instance, a clinical research associate (CRA) creates a template in the UAT lifecycle to test, adjust, and validate it. Then the validated template can be exported from UAT and imported to PROD.

To export 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. In the ICF Tracking Log Template List table that appears, select the checkbox(es) next to the template(s) you want to export. Then from the workspace toolbar, select Export export_icon.png.

    Exporting ICF tracking log template file
    Figure 2. Exporting ICF tracking log template file

The ICF tracking log template now becomes available on your computer as .config files and can be managed offline as needed.

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.

A person responsible for overseeing and monitoring a clinical trial to ensure it is conducted in compliance with regulatory standards and protocols. The CRA’s scope of work might include protocol review, site selection and initiation, monitoring, data entry control, and more.

In the eClinical system, the Clinical Research Associate (CRA) user role is assigned to a person who works with the sites, and in EDC, mainly has to make sure that the entered data is truthful to the source document. CRA checks the source document in a process called source data verification and ensures that everything entered by the clinical research coordinators is valid to avoid any discrepancies caused by human errors.