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Configure ICF tracking log template form

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. For each template you create, you can configure a unique form by adding questions and items according to your needs and protocol requirements.

ICF tracking log template form configurator
Figure 1. ICF tracking log template form configurator

In the following sections, you can learn how to configure your template forms and use available tools.

Add question to ICF tracking log template form

In CTMS, you can create a library of ICF tracking log templates that can be reused throughout your studies. For each template you create, you can configure a unique form by adding questions and items according to your needs and protocol requirements.

To add a question to an ICF tracking log template form

  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 you want to configure and select its name.

    Accessing template configuration
    Figure 2. Accessing template configuration

  4. On the page that opens, start configuring questions of the form in one of the following ways:

    1. To add preconfigured questions, from the workspace toolbar, click Select Predefined Items select_predefined_items_icon.png. Then in the dialog that opens, select the checkboxes next to questions you want to add to your form and select save_button.png.

      Adding predefined questions
      Figure 3. Adding predefined questions

    2. To add a custom question, select Question add_question_icon.png and in the New Question panel that opens, configure your question as explained in the following table.

      Adding custom question
      Figure 4. Adding custom question

      Element

      Details

      Field Label*

      Enter the text of your question that is to be displayed in a form in the final output.

      Help Text

      Enter any helpful details, directives, or suggestions on field completion that are to be displayed as a legend for your form field in the final output.

      Rich Text

      Select rich_text_icon.png to open the Help Text dialog and amend your text using formatting tools.

      Entering help text
      Figure 5. Entering help text

      CLEAR

      Select clear_icon.png in the Help Text field to clear the contents and start over.

      SAVE

      Select save_button.png to save the changes.

      CANCEL

      Select cancel_button_white_blue.png to discard the changes without saving.

Once saved, the question is added to your form. You can now add an item to a question.

Add item to ICF tracking log template form

In CTMS, you can create a library of ICF tracking log templates that can be reused throughout your studies. For each template you create, you can configure a unique form by adding questions and items according to your needs and protocol requirements.

To add an item to an ICF tracking log template form

  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 you want to configure and select its name.

    Accessing template configuration
    Figure 2. Accessing template configuration

  4. On the page that opens, start adding items to questions on the form. For this, select the item type you need from the form configuration tools panel. The available item types are explained in the following table.

    Available item types
    Figure 3. Available item types

    Element

    Details

    Text Text_icon.png

    Represents a text field for a brief description.

    Select this type to create questions for additional comments and such.

    TextArea TextArea_icon.png

    Represents a larger text field for long descriptions.

    You can select this type to acquire a detailed description of the ICF tracking log record.

    ListBox list_box_icon.png

    Represents a dropdown list from which the user can select only one option to answer the question.

    You can select the ListBox option to add questions about the protocol version or others.

    The list of options is fetched from Code List. Therefore, before creating such questions, the code list must be prepared.

    Radio radio_format_icon.png

    Represents multiple options in the form of option buttons from which the user can select only one to answer the question. This data type is usually used for displaying up to 5 options. If your questions have more options, then the ListBox is recommended.

    Select the Radio data type to add questions like: "Was the ICF signed by the subject?".

    The multiple options displayed in the form of option buttons are fetched from Code List. Therefore, before creating such questions, the code list must be prepared.

    CheckBox check_box_icon.png

    Represents multiple options from which the user can select one or more options to answer the question.

    Use the CheckBox data type to add questions like: "Select the type of safeguards utilized by research personnel".

    The multiple options displayed are fetched from Code List. Therefore, before creating such questions, the code list must be prepared.

    Time Time_icon.png

    Represents fields to enter time in various formats, such as hour/minutes, hour/minutes/seconds, and others.

    You can select this option to inquire about the time when the ICF is approved or signed, and so on.

    Date Date_icon.png

    Represents fields to enter a date in various formats, such as date/month/year, month/year, and others.

    You can select this option to inquire about the date when the ICF is approved or signed, and so on.

    Integer integer_format_icon.png

    Represents a numeric field to enter a number only.

    This type can be selected to include questions, such as "Enter the total number of subjects participating in the study".

    Float float_icon.png

    Represents a numeric field that allows entering a number with a decimal point.

    Select this type to include questions that inquire about the amount of drug used in a study.

    Code list Group code_list_group_icon.png

    Represents a combination of dropdown lists. In order to answer the question, the user must select one option from each of the dropdown lists provided.

    You can select the Code list Group option to add questions inquiring about the site address, where one dropdown list includes provinces, the second includes cities, and the last one may include a list of streets.

    The combination of the dropdown lists and the items displayed in the lists are created and fetched from Code List. Therefore, before creating such questions, the code list must be prepared.

  5. Once the item type is selected, in the New panel that expands, configure your question details as explained in the following table.

    Configuring item question
    Figure 4. Configuring item question

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Data Type*

    While adding the question, if you wish to change the data selected from the one that you have selected at the previous step, then from this dropdown list, select a different data type.

    Code List*

    Select the code list that includes the options from which you want the user to select an answer.

    This option is only displayed if you have selected the following data types: ListBox, Radio, CheckBox, Code list Group.

    Caption*

    Enter a unique caption text for a question that you want to include in the protocol deviation template.

    Question*

    Enter a unique question text that you want to include in the protocol deviation template.

    Format*

    Select the format in which you want the user to provide their answer, such as month/date/year, hour/minutes/seconds, and so on.

    This option is only displayed for the Date and Time data types.

    Precision

    Enter a precision value up to which you want the user to provide a decimal value in the answer field.

    For example, if you set the precision value to 2, then the user can enter the value "2.02" in the answer field.

    This option is only displayed for the Float data type.

    Required

    Turn the toggle on if you want the question to be mandatory in the protocol deviation template.

    Help Text

    Enter additional information, instructions, or clarification about the item. It may include details on how to answer a corresponding question or what data is collected in the field.

    You can also select Rich Text rich_text_icon.png to open the text editor where you can format the text with a variety of styling options. The rich text editor provides a wide range of formatting capabilities such as adding bulleted or numbered lists, making a text bold or italicized, and more.

    Entering text in rich text editor
    Figure 5. Entering text in rich text editor

    SAVE

    Select save_button.png to save your changes.

    CANCEL

    Select cancel_button_white_blue.png to discard your changes.

Once saved, the question is added to your form. You can also move this question to position it according to your needs.

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.