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Modify ICF tracking log template form

In CTMS, you can modify the questions that you have added in the ICF tracking log template form.

This may be helpful if you have cloned an existing template and you want to modify some questions as per your requirement or the questions currently added are not sufficient enough to acquire the complete details of the ICF tracking log, or there is an error in some question, or due to some other reason.

There are several modification options provided for you to alter an ICF tracking log template as explained in the following sections.

Edit item in ICF tracking log template form

You can edit a particular question in the ICF tracking log template. This may be helpful if a specific question in the template requires modification in its text, data type, format, or so on.

To edit an item in 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. In the form that appears, locate the question that you want to edit. Then next to it, select More more_icon.png > Edit Item pencil_icon.png.

    Selecting to edit item
    Figure 3. Selecting to edit item

  5. In the panel that expands, modify the details of the questions as required as explained in the following table.

    Editing item details
    Figure 4. Editing item details

    Tip

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

    Element

    Details

    Data Type*

    Represents the data type selected upon adding an item to the form. The field is read-only.

    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, or Code list Group.

    Caption*

    Represents the caption text for a question entered upon adding an item to the form. The field is read-only.

    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 item is edited.

Set item dependency in ICF tracking log template form

You can set dependency rules between a particular question and the answer to another question in the ICF tracking log template. This may be helpful if a specific question only should appear if the previous question is answered in a certain way.

For instance, you can set the Date of Subject Signature field to only appear in your form if the answer to the question Subject Signed ICF? is Yes.

To set item dependency in an ICF tracking 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 appears, locate the question for which you want to set a dependency on another question item. Then next to it, select More more_icon.png > Dependence reference_item_icon.png.

    Continuing our example, to make the Date of Subject Signature question dependent on Subject Signed ICF? = Yes, we select the Dependence option for Date of Subject Signature.

    Selecting set dependency
    Figure 3. Selecting set dependency

  5. In the Depemdence dialog that appears, from the tree, select the question to which you want to create the association. Then from the Define a Condition block, select the checkboxes next to the options that should trigger your dependency rule.

    Continuing our example, select the checkbox next to Yes to complete the following dependency: if Subject Signed ICF? = Yes, then the Date of Subject Signature question appears.

    Setting question dependency
    Figure 4. Setting question dependency

  6. Select save_button.png to save your changes.

Upon saving, the dependency is set between the questions of the ICF tracking template.

Move item in ICF tracking template form

Using this functionality, in the ICF tracking log template, you can move a question to a specific location, such as if you want to place the signature date before the signature date, place the principal investigator's name before the subject ID, and so on.

To move an item in an ICF tracking 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 Details page that appears, locate the question that you want to move. Then next to it, select More more_icon.png > Move move_at_top_icon.png.

  5. In the second dropdown menu that opens, select an option as explained in the following table.

    Selecting option to move question
    Figure 3. Selecting option to move question

    Element

    Details

    Move Bottom move_to_bottom_icon.png

    Select this option to move the selected item to the bottom of the template form; that is, the question is placed at the end of the template form.

    Move Top move_at_top_icon.png

    Select this option to move the selected item to the top of the template form; that is, the question becomes the first one in the template form.

    Move Down move_down_icon.png

    Select this option to move the selected question one place below its current position in the template.

    Move Up move_up_icon.png

    Select this option to move the selected question one place above its current position in the template.

    Tip

    Alternatively, you can move a question by dragging it to its required position.

    Moving question by dragging
    Figure 4. Moving question by dragging

You have moved your questions to place them in the form in the required order.

View operation history of item in ICF tracking template form

In CTMS, you can view operation history of a column in the ICF tracking log template. You may want to view the history to analyze details of edits, such as who made the changes, what was modified, and when the updates occurred—supporting transparency and audit readiness.

To view the operation history of an item in an ICF tracking 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 Details page that appears, locate the item that you want to analyze. Then next to it, select More more_icon.png > Operation History history_icon.png.

    Accessing operation history of item in ICF tracking template
    Figure 3. Accessing operation history of item in ICF tracking template

  5. In the dialog that opens, analyze the details of the changes made to the item.

    Analyzing operation history of question in ICF tracking template
    Figure 4. Analyzing operation history of question in ICF tracking template

Once you have analyzed the item's change history, select OK to close the dialog and return to the ICF tracking log template form.

Delete item from ICF tracking log template form

You can delete a specific question from an ICF tracking log template if it is no longer required. This may be required if a question has some errors, does not acquire relevant information, or there is some other reason.

Important

You can only delete custom-created items or predefined items added manually to the form. You cannot delete the items added to your form by default—Site Code, Subject ID, or Signed ICF Name and Version as they are mandatory for all ICF tracking log templates. However, you can edit these items or move them.

To delete an item from 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, locate the question that you want to delete. Then next to it, select More more_icon.png > Delete trash_can_icon.png.

    Selecting to delete item
    Figure 3. Selecting to delete item

  5. In the Delete Item dialog that appears, confirm the action by selecting delete_button_white_red.png.

    Confirming question deletion
    Figure 4. Confirming question deletion

Once confirmed, an item is deleted from the ICF tracking log template form.

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 conducting the research study at a specific investigational site or multiple sites, depending on the study's design. The role of a PI is multifaceted and involves various responsibilities, such as study oversight, protocol adherence, participant recruitment and informed consent implementation, regulatory compliance, and so on.

In the eClinical system, the Principal Investigator (PI) role that is assigned to a person who oversees the data entering and signs off subjects—gives authorized confirmation that all the entered data is valid and follows the industry standards. The responsibilities of PI can vary depending on study requirements.