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Add simple or log form to monitor template

The simple or log form is a collection of questions and items that need to be answered to assemble specific subject-related data. There are various form field options such as text fields, checkboxes, date pickers, and more. You can place these fields on the form canvas and arrange them as needed.

Tip

A question refers to a sentence or phrase that seeks information or clarification about a specific topic related to the subject. An item refers to a field within the form corresponding to a particular question. For example, a question can be "Gender" and an item for this question can be a listbox with "Female" and "Male" responses.

For example, you can create simple forms for acquiring information about subject enrollment and retention, protocol compliance, safety reporting questions, clinical supplies and facilities, and so on. Similarly, a log form can be created to ask questions related to reviewing informed consent, source data verification, deviations discovered at the site, and others.

To add a simple or log form to the monitor template

  1. In the CTMS application header, select the LIBRARY tab.

  2. From the left pane of the page that opens, select Monitor Template.

    Accessing monitor template subtab
    Figure 1. Accessing monitor template subtab

  3. From the Monitor Template List table, select the template where you want to add a new form.

    Selecting monitor template
    Figure 2. Selecting monitor template

  4. In the explorer tree of the page that opens, right-click the template name and select New Form folder_icon_gray.png.

    Selecting option to add new form
    Figure 3. Selecting option to add new form

    Important

    In the Version field, you can select another version of the monitor template to view its questions. However, you cannot add or modify fields in previous template versions if the particular version of the template is already used in monitoring plans.

  5. In the New panel that expands, enter a unique name for the form and select its type which is either Simple Form or Log Form. Then select save_button.png.

    Adding form to monitor template
    Figure 4. Adding form to monitor template

Upon saving, a simple or log form is created. It appears in the explorer pane of the Monitor Template Detail page with the respective icon next to it: simple_form_icon.png for a simple form and log_form_icon.png for a log form. You can now proceed with adding questions to the simple or log form.

Add questions to simple or log form

Once a simple or log form is created, start adding questions and items to the form using various editing tools. In a simple or log form, you can add questions with various items such as labels, option buttons, checkboxes, lists, dates, and so on.

Tip

A question refers to a sentence or phrase that seeks information or clarification about a specific topic related to the subject. An item refers to a field within the form corresponding to a particular question. For example, a question can be "Gender" and an item for this question can be a listbox with "Female" and "Male" responses.

To add questions to a simple or log form

  1. In the CTMS application header, select the LIBRARY tab.

  2. From the left pane of the page that opens, select Monitor Template.

    Accessing monitor template subtab
    Figure 1. Accessing monitor template subtab

  3. From the Monitor Template List table, select the needed monitor template.

    Selecting monitor template
    Figure 2. Selecting monitor template

  4. In the explorer tree of the page that opens, select the simple or log form to which you want to add questions.

  5. In the contents panel that appears, start configuring questions of the form in one of the following ways:

Upon confirmation, the questions and items are added to a simple or log form. You may proceed with submitting the monitor template if you do not wish to add any other forms to the template.

Modify simple or log form data

In CTMS, you can modify the data (questions) that you have added in the simple or log form. This may be required if you have cloned an existing template and you want to modify the data added in the simple or log forms as per your requirement or the questions currently added are not sufficient enough to acquire the complete details of the deviation, or there is an error in some question, or due to some other reason.

Important

Before you start any modification, ensure the following:

  1. The monitor template in which the required simple or log form exists is not in use in STUDY MANAGEMENT > Monitoring > Monitoring Visit. If it is in use, then you may create a new version of the monitor template and modify it as required.

  2. The monitor template is inactive. If it is not, then you may inactivate it first and then proceed with the required modifications.

There are several modification options provided for you to alter a simple or log form as discussed in the following sections.

Edit item in simple or log form

Every question on the simple or log form is usually associated with an item or items that need to be answered to assemble specific subject-related data. There are various form field options such as text fields, checkboxes, date pickers, and more. You can edit these fields when the necessary updates are required due to protocol changes or other reasons.

To edit an item in a simple or log form

  1. In the CTMS application header, select the LIBRARY tab.

  2. From the left pane of the page that opens, select Monitor Template.

    Accessing monitor template subtab
    Figure 1. Accessing monitor template subtab

  3. From the Monitor Template List table, select the template name in which the required simple or log form exists.

    Selecting monitor template
    Figure 2. Selecting monitor template

  4. From the explorer tree of the page that opens, select the required simple or log form.

  5. On the form content page that appears, locate the question that you want to modify. Then next to the needed item of this question, select More more_icon.png > Edit pencil_icon_gray.png.

    Selecting option to edit question item
    Figure 3. Selecting option to edit question item

  6. In the Edit panel that expands, update the fields as needed. These fields are identical to the ones explained in the table of the Add questions to simple or log form section. The number and type of fields may vary depending on the item data type you edit.

    Editing question item
    Figure 4. Editing question item

  7. Select save_button.png.

Upon saving, the question items in the simple or log form are updated.

Add item dependence in simple or log form

In CTMS, you can associate two items in a simple or log form of a monitor template in a way that until one of the items is answered, the other one remains hidden. Therefore, by making one item dependent on the other one, you create lineage between the form questions and enable the creation of multivariant questions.

For example, you can first ask the reviewer: "Have any Safety Adverse Events (SAEs) other than the ones specified in protocol occurred?". If the user answers, "Yes", then you can ask the reviewer: "Have SAEs been reported to Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs)?"

To add an item dependence in a simple or log form

  1. In the CTMS application header, select the LIBRARY tab.

  2. On the page that opens, from the left pane, select the Monitor Template subtab.

    Accessing monitor template subtab
    Figure 1. Accessing monitor template subtab

  3. From the Monitor Template List table, select the template name in which the required simple or log form exists.

    Selecting monitor template
    Figure 2. Selecting monitor template

  4. On the Monitor Template Detail page that appears, from the explorer pane, select the required simple or log form.

  5. In the form, locate the needed question item. Then next to it, select More more_icon.png > Depend reference_item_icon.png.

    Selecting option to edit question
    Figure 3. Selecting option to edit question

    Tip

    If you want to display the comment field answer option to the reviewer as well, then after adding dependence on the option buttons, repeat the same step for the comment field as well.

  6. In the Depend dialog that appears, select the question and next to it, select the particular answer based on which you want to ask the dependent question from the reviewer.

    Selecting depending question
    Figure 4. Selecting depending question

    Tip

    You can add dependence on multiple questions if required. That is, in the Depend dialog, after selecting an answer option for one question, you can move to the second question, and select the required answer option based on which you want to display the dependent question.

    This way, if the reviewer provides the particular answers for the questions, only then the dependent question is asked.

    For example, question 1 has two probable answers: Yes or No (option buttons), and question 2 has two data types of answers: Yes/No (option buttons) and a text field for adding comments.

    If based on the answer No to question 1, you want to ask the reviewer question 2 and provide them both the answer data types: Yes/No and the comment field. Then, in this step, select the option Yes/No of question 2 and add dependence on the answer No of question 1. Once done, repeat the same step for the comment field option. That is, in this step, select the comment field option and add dependence upon the answer No to question 1.

    As a result, if the reviewer answers No to question 1, then the system asks them question 2 and provides them Yes/No option buttons and a comment field to answer.

    Dependence explanation
    Figure 5. Dependence explanation

  7. Select save_button.png to save your changes.

Upon saving, the dependence on a question item is added. The dependent question is not asked until a required answer is provided on the depending question by the reviewer.

Move item in simple or log form

In log and simple forms, you can move an item, that is a question or a particular answer option of a question to a required position. For example, you may want to place the question "Was a pre-study visit (PSSV) completed?" before the question "Was a waiver granted?", or for a question, you may want to place the option buttons answer option before the comment field option, and so on.

To move an item in a simple or log form

  1. In the CTMS application header, select the LIBRARY tab.

  2. From the left pane of the page that opens, select Monitor Template.

    Accessing monitor template subtab
    Figure 1. Accessing monitor template subtab

  3. From the Monitor Template List table, select the template name in which the required simple or log form exists.

    Selecting monitor template
    Figure 2. Selecting monitor template

  4. On the Monitor Template Detail page that appears, from the explorer pane, select the required simple or log form.

  5. In the form that opens, locate the needed question item. Then next to it, select More more_icon.png > Move move_at_top_icon.png. From the second dropdown menu, select an option as explained in the following table.

    Selecting option to move item in simple or log form
    Figure 3. Selecting option to move item in simple or log form

    Element

    Details

    Move Bottom move_to_bottom_icon.png

    Select this option to move the selected item to the bottom of the 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 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 item one place below its current position in the template form.

    Move Up move_up_icon.png

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

    Tip

    Alternatively, you can move an item by dragging it to its required position.

    Dragging item to reposition
    Figure 4. Dragging item to reposition

After the required manipulations, the item is moved to your required position in the simple or log form.

View operation history of item in simple or log form

In CTMS, you can access the change history of a specific question within a log and simple forms. 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 a simple or log form

  1. In the CTMS application header, select the LIBRARY tab.

  2. From the left pane of the page that opens, select Monitor Template.

    Accessing monitor template subtab
    Figure 1. Accessing monitor template subtab

  3. From the Monitor Template List table, select the template in which you want to modify the data.

    Selecting monitor template
    Figure 2. Selecting monitor template

  4. On the Monitor Template Detail page that appears, from the explorer pane, select the required simple or log form.

  5. In the form, locate the question that you want to analyze. Then next to it, select More more_icon.png > Operation History history_icon.png.

    Accessing operation history of simple or log form item
    Figure 3. Accessing operation history of simple or log form item

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

    Analyzing operation history of simple or log form item
    Figure 4. Analyzing operation history of simple or log form item

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

Delete item from simple or log form

Every question on the simple or log form is usually associated with an item or items that need to be answered to assemble specific subject-related data. There are various form field options such as text fields, checkboxes, date pickers, and more. You can delete questions or items from the form when the necessary updates are required due to protocol changes or other reasons.

To delete an item from a simple or log form

  1. In the CTMS application header, select the LIBRARY tab.

  2. From the left pane of the page that opens, select Monitor Template.

    Accessing monitor template subtab
    Figure 1. Accessing monitor template subtab

  3. From the Monitor Template List table, select the template name in which the required simple or log form exists.

    Selecting monitor template
    Figure 2. Selecting monitor template

  4. On the page that opens, locate the question or item you want to delete. Then next to it, select More more_icon.png > Delete pencil_icon_gray.png.

    Selecting option to delete question or item
    Figure 3. Selecting option to delete question or item

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

    Confirming deletion
    Figure 4. Confirming deletion

Upon confirmation, the question or item is deleted from the simple or log form.

In this section:

Any person, company, institution, group, or organization that is a client of EDETEK and a user of the eClinical system.

In the eClinical system, the Sponsor role is assigned to the user who oversees or pays for a clinical trial and collects and analyzes the data. Before the study goes live, the Sponsor users work closely with the data managers, configuring CRFs and other aspects to make sure everything meets their requirements before giving the green light for the study to go live. In the course of a trial, the Sponsor users make requests for amendments in the system according to a new protocol version, changes in business requirements, or other needs.

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.

A monitor template is created for recording the details of a monitoring visit, such as information about the subject's enrollment and retention, source data verification, protocol deviations discovered at the site, and so on. Since the monitoring visit data may vary, to accurately and efficiently capture and record the information, you can create the following types of forms in a monitor template: simple, log, and grid.

The simple and log forms are straightforward and incorporate questions and answers for the reviewer to provide details of their monitoring visit. Grid forms are two-dimensional forms comprising rows and columns that can be used to answer multiple questions for different fields of the same question.