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Import ICF tracking log template

ICF tracking log is 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.

In CTMS, you can create a library of ICF tracking log templates that can be reused throughout your studies. This section concentrates on how to create such a template by importing a preconfigured file from your computer.

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

To import 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. On the ICF Tracking Log Template List page that opens, from the workspace toolbar, select Import import_icon.png.

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

  4. On your computer, locate and select the file in the .config format that you want to import to the system as an ICF tracking log template.

Once the file is imported, you can find it in the ICF Tracking Log Template List table with the import detail added to the template name.

Locating imported template
Figure 3. Locating imported template

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 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.