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ICF listing

The ICF listing is intended to record all the Informed Consent Forms (ICFs) of your study—both master and site ones—whose completion you want to trace via the tracking log.

  • Master ICFs: the general ICFs designed for the study according to the regulatory requirements and protocol specifications.

  • Site ICFs: the ICFs designed based on the master ICFs to satisfy certain site-specific requirements and adjustments due to geographical, regulatory, auditorial, and other aspects.

ICF listing module in CTMS
Figure 1. ICF listing module in CTMS

In CTMS, from the ICF Listing module, you can manage the relations of site and master ICFs, access their main details, such as protocol version or else, as well as maintain versioning.

Export site/master ICF listing records

In CTMS, from the ICF Listing module you can export the list of ICF tracking records for master ICFs or site ICFs of your study as the XLSX file to your computer for sharing with stakeholders or other business purposes.

To export the site or master ICF listing records

  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 study management page that opens, from the left pane, select ICF > ICF Listing.

    Accessing ICF listing
    Figure 3. Accessing ICF listing

  3. On the page that opens, select the needed tab—Site ICFs or Master ICFs. Then from the workspace toolbar, select Export export_icon.png.

    Selecting to export ICF listing records
    Figure 4. Selecting to export ICF listing records

  4. In the downloads widget that appears, view your download progress. Select the widget to open the My Downloads dialog.

    Downloads widget showing ICF records being exported
    Figure 5. Downloads widget showing ICF records being exported

  5. In the My Downloads dialog that opens, you can find the following tabs:

    • Preparing: lists all the files whose export is in progress, and they are not yet ready for download. Wait until the needed file moves to the Download is Ready tab.

    • Download is Ready: lists the files whose export is complete, and they can be downloaded to your computer by selecting download_icon.png.

    Downloading ICF listing records report
    Figure 6. Downloading ICF listing records report

Once downloaded and saved, the site or master ICF listing data in the XLSX format becomes available on your computer.

Tip

The extracted file version is saved in the system and can be accessed from Export History export_history_icon.png.

Accessing master ICF listing export history
Figure 7. Accessing master ICF listing export history

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.