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Add text item to question

In Study Designer, study teams have a variety of tools to configure case report forms (CRFs) for data collection. There are various items— text fields, checkboxes, dropdown menus, date pickers, and more—that you can add as form fields next to their respective questions. You can place these fields on the form canvas, arrange them as needed, and make sure they are associated with the corresponding variables. This provides flexibility to outline the way each question must be answered by the user, and how the data must be stored by the system.

One of the items that you can add to the form questions is a text item. Text items are suitable when you expect a relatively short text response, typically limited to a few words or a sentence. They are commonly used for collecting data such as names, codes, or single-word answers.

For example, if you need to collect the patient's initials or a specific code related to the study, a text item is appropriate.

To add a text item to a question

  1. In the Study Designer application header, select the CRF DESIGN tab.

  2. In the toolbar, select the latest draft CRF version marked with the respective unlock symbol unlocked_icon_purple.png, otherwise, you cannot perform any actions.

    Selecting latest draft CRF version
    Figure 1. Selecting latest draft CRF version

  3. In the left pane that appears, expand the unique form directory of any visit. Then select the needed form.

    Important

    Note that by updating a unique form, you introduce changes to all visit forms linked to it and vice versa.

    Accessing form to configure
    Figure 2. Accessing form to configure

  4. On the form content page that appears, select the option to add a text item to the question in one of the following ways:

    • From the action bar, select Text icon_text.png.

      Selecting text item
      Figure 3. Selecting text item

    • From the action bar, select and drag Text icon_text.png to the needed question.

      Dragging text item to question
      Figure 4. Dragging text item to question

    • If there has been at least one item already assigned to the question, then next to any item, select More icon_more_actions.png > New Item icon_new_item.png.

      Adding text to existing item
      Figure 5. Adding text to existing item

  5. In the Add Item panel that expands, under the Generate tab, fill in the general details as explained in the following table.

    Adding text item
    Figure 6. Adding text item

    Tip

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

    Element

    Details

    Type*

    Select the Text type here.

    Caption*

    Enter a short title or description that defines the added item.

    Use Rich Text to format the caption text if needed.

    Rich Text

    Select rich_text_icon.png next to Caption or Help Text fields to open the text editor dialog and style your text as needed using the available formatting tools. The rich text you apply defines how your question text is displayed in the CRF when it is completed via EDC, eDiary, or eCOA.

    Question*

    Select the question to which the item is being added.

    If the Custom Question checkbox is selected, then you need to enter the question text manually.

    Custom Question

    Select this checkbox if you want to add a new custom question along with the created item to the form.

    If selected, it is required to enter a custom question text in the Question field.

    Show Caption

    Turn on this toggle to show the indicated caption next to the item on the form. Leave the toggle turned off to hide the caption text from the form.

    Text Align

    Select either the right or left alignment of the item on the form in relation to its question.

    Auto-query for Required Field

    Turn on this toggle if you want the field associated with the item to become required for data entry in the EDC system, and submitting the form with this field empty automatically triggers a system query. Leave the toggle turned off if this field can be optional for data entry.

    Missing data affects form status

    Turn on this toggle if you want the CRF to have the Incomplete status in the EDC system when the data has not been entered in the field associated with the item. Leave the toggle turned off if you do not want this field's status to affect the status of the CRF upon submission.

    This toggle becomes available only if the Auto-query for Required Field toggle has been switched on.

    Require SDV

    Select this checkbox to set the source data verification (SDV) stage as mandatory for this data item.

    Requires Manual Reviews

    Select the checkbox next to the needed review stage to set it as mandatory for this data item. The available options are DM Review for the data manager review, CRA Review for the clinical research associate review, and Safety Review for the safety team review.

    Restrict Manual Entry

    Turn this toggle on if you want to prevent manual data entry to the field for all users except for those for whom restricted data editing is allowed in EDC. Leave the toggle turned off if you do not need to arrange specific data entry restrictions for this element.

    Help Text

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

    Use Rich Text to format the help text if needed.

    SAVE

    Select save_button_red_white.png to add the item to the question.

    This button is available only if the variable definition for the item has been specified.

    CANCEL

    Select cancel_button_white_blue.png to cancel adding the item.

  6. In the same Add Item panel, go to the Definition tab to specify the variable definition for the item as explained in the following table.

    Specifying variable definition for text item
    Figure 7. Specifying variable definition for text item

    Important

    All fields in the following table are required and marked with an asterisk (*) because the text item must be associated with the variable that captures the data entered in EDC.

    Element

    Details

    Data Type*

    Select the type of data that is to be collected for a corresponding question. The data type is usually preselected by the system but can be changed depending on the allowed data types for the selected CDASH variable.

    Length*

    Enter the maximum number of characters or digits that the field can capture when entering data in EDC. The length is usually defined by the system according to the selected CDASH variable but can be updated.

    CDASH Variable*

    Enter the name of the CDASH variable that is to capture data specified in a corresponding field in EDC. You can either select one of the available domain variables or enter a name for the custom one. The field only supports uppercase letters, numbers, and underscores.

    CDASH Label*

    Enter the label for the CDASH variable that is to capture data entered in a corresponding field in EDC. The label is usually defined by the system according to the selected CDASH variable but can be updated.

    RecordID*

    Enter the record number that enables different fields on the form associated with the same variable to capture data records in separate rows. These records will be presented accordingly in the output dataset upon data entry in EDC.

    For example, in the Vital Signs form, you have the questions "Pulse", "Temperature", and "Respiratory Rate". The text item is assigned to all three questions and it is specified that the VSORRES variable is to capture the corresponding data.

    In order to distinguish the collected vital sign results in a more organized manner, you can assign "record ID = 1" to the text item of the "Pulse" question, "record ID = 2" to the text item of the "Temperature" question, and "record ID = 3" to the text item of the "Respiratory Rate" question. In such a way, the captured results will be displayed in separate record rows in the output dataset.

    Moreover, you can enter record IDs separated by commas if you want the specific data point to repeat in the output dataset.

    SAVE

    Select save_button_red_white.png to add the item with the specified variable definition to the question.

    CANCEL

    Select cancel_button_white_blue.png to cancel adding the item.

Once saved, the text item is added to the form question. You can now continue to maintain forms with available actions.

In this section:

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.

An individual piece of data collected within a domain. It represents a specific attribute or characteristic that can vary among subjects in a study. Each variable is defined by its format (such as categorical, continuous, and so on) and plays a crucial role in data analysis, allowing researchers to assess relationships and outcomes in the study.

For instance, within the "Demographics" domain, variables might include "Age," "Gender," and "Ethnicity."

An eClinical application that is mainly used to collect and manage subject data during clinical trials. It integrates with the Study Designer (SD) application and uses preconfigured there case report forms (CRFs) to complete data collection and management. It also provides an audit trail, data alert, source data verification (SDV), payment management, adjudication, and other functions as well as supports data export according to the CDISC ODM standard.

Get to know all the possibilities of the app with the comprehensive EDC User Guide.

An eClinical mobile application used for the collection and management of clinical data of subjects, supporting iOS and Android systems. It is based on the electronic CRF provided by the Study Designer application to support subjects' self-recording of treatment and diagnosis information.

An eClinical mobile application designed for the collection of clinical outcome assessments, such as patient-reported outcomes, questionnaires, and other data related to the participant's health, symptoms, or treatment experiences.

A process of ensuring data accuracy and integrity within a clinical trial. SDV involves the review and comparison of data recorded in the source documents against the data captured on the case report forms (CRFs). During SDV, a trained monitor or clinical research associate (CRA) compares the source data to the CRFs to identify any discrepancies or errors. They may review laboratory results, medical history, adverse event records, and other relevant information. Discrepancies found during SDV are usually documented and resolved through data clarification or query processes with the site personnel responsible for data collection.

A person responsible for managing and ensuring the integrity, accuracy, and confidentiality of data collected during clinical trials. The DM’s scope of work might include maintaining the quality of data, complying with regulatory requirements, and supporting the overall success of clinical research.

In the eClinical system, the Data Manager (DM) user role is granted to a person who is mainly responsible for cleaning the data, making sure the data is entered correctly according to all requirements and industry standards, and creating manual queries for clinical research coordinators on any questionable data pieces. Before the study goes live, works with the sponsor and receives and addresses their feedback to set up the study and CRFs in EDC in a way that the sponsor approves.

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.