Properties define the overall functionality and behavior of Forms, Design Tools and Form Fields. This document explains each of the Form Fields that can be used on a form and the Properties associated with them. Properties can be edited by selecting the Form and then selecting the Form Field in the Form Builder body/grid. Selecting the Form Field will open the associated Properties section in the Toolbox. To save any changes made to a Form Field, click the Save Form button located in the top right corner of the Form Builder. It is important to “save” often while building forms to be sure changes are not lost.
The Form Builder application can be accessed from either the Website Host menu or the Study menu as shown in the following figures. The Form Builder functionality and the Form Field Properties are exactly the same. The only exception is the type of forms that can be created using the application. The Website Host Form Builder can be used to create Site, Study, and User forms while the Study Form Builder can be used to create Site, Study and Subject forms. The form types created at each level will be accessible using various applications in Clinical Studio.
When the Form Builder is accessed from either the Website Host or Study menus, the Form Builder page is displayed. The Form/Page Properties and Form Fields with their associated Properties are displayed in the Toolbox located on the left side of the Form Builder page.
The Properties applicable to a “Form” will be discussed in the following section. The subsequent sections include an explanation of each of the individual Form Fields (Text, Number, Drop Down, Radio Group, Date/Time, Memo, Checkbox, Email Address and File Upload) that can be placed on a “Form” to capture data and the Properties associated with each Form Field.
The following figure shows the Form/Page Properties that can be used for a form.
Each Form/Page property is explained below.
Form Name – This is the title of the form that will appear in the corresponding pages and related applications where the form is used. Note: The Form Name is how the form is characterized in the database. It is always smart to add the same title to the top of the form workspace as well. This way the end user of the form will clearly see which form is currently open as it is completed.
Form Type (Website Host Level) – The Form Type drop-down choices when the Form Builder application is used at the Website Host level are: User, Site, and Study as shown in the figure below. Forms designated as User forms populate the Current Users data table on the User Manager page. Forms designated as Site forms populate the Current Sites data table on the Site Manager page. Forms designated as Study forms populate the Current Studies data table on the Study Manager page. The User Manager, Site Manager, and Study Manager applications are all accessed from the Website Host menu.
Form Type (Study Level) – The Form Type drop-down choices when the Form Builder application is used at the Study level are: Subject, Site, and Study as shown in the figure below. These form types correspond to various Study level applications. Forms designated as Site Forms appear in the Site Document Manager application accessed from the Study menu. Forms designated as Subject Forms appear in the Subject Manager application accessed from the Subject menu. Forms designated as Study Forms appear in the Access Study Related Forms application accessed from the Subject menu.
Sequence – This is a number assigned to determine the order in which the forms will appear in both the Existing Forms data table and related applications. For example, there are three Site Type Forms in the Existing Forms data table in the Study Level Form Builder: Site Progress Report, Site Personnel and Site Assessment Questionnaire as shown in the figure below.
The Site Progress Report form was created and saved with a sequence of 1, the Site Personnel form was created and saved with a sequence of 2 and the Site Assessment Questionnaire was created and saved with a sequence of 3. Therefore, the forms appear in that order in the Existing Forms data table (shown above) as well as the in the Sites data table in the Site Document Forms column in the Site Document Manager application as shown in the figure below.
As previously noted, Site Forms created at the Study level populate the Site Document Manager which is accessed from the Study menu.
Save Button Text – This property allows the Form Designer to determine the text that appears on the “Save” buttons for each form. For example, the button text for the Site Assessment Questionnaire form might be, “Save Site Questionnaire Form” or “Save Site Questionnaire”. To create the Save button text, click in the text box next to the Save Button Text and enter the desired button text as shown below.
When rendered on the form, the button text will appear as shown in the following figure. Notice the text “Final” was automatically added to the Save Button Text entered in the field. Depending on how a study is configured “Draft” or “Final” may be appended to the Save Button text entered. (“Draft” will be appended to Subject type forms if in the Study Configuration application, Allow Subject Case Report Forms to be Saved as Draft box has been checked on the Functionality tab. If the checkbox has been selected, then one button with “Draft” and one button with “Final” appears. That way, the form can be saved multiple times in draft mode before a final submission is made.)
Note: The “Save” button will not appear on the Form Builder Body/Grid or in the form Preview window.
ToolTip – This tool is used to enter text into a dialogue box that will appear when the mouse hovers over the field.
To use the tool, select the desired field and click the View/Edit control. Clicking the View/Edit control displays the ToolTip pop up window where the desired text can be entered. When the text has been entered, click the OK button. The text will be saved when the Save Form button is clicked before leaving the Form Builder application. The text entered can be used to provide the person entering data into the form any additional information about the field or simply how the information should be entered as shown in the figure below.
Currently, ToolTips are only available at the field level.
Omit Review Levels (Study Level) – Forms created at the Study level can be set up to require specified review levels using the Study Configuration application accessed from the Study menu. Selecting one or more of the checkboxes will prevent the selected review level requirement for the form. Review level requirements are established using the Workflow tab on the Study Configuration Settings page which is accessed using the Study Configuration… link from the Study menu.
Validations allow a Form Designer to define the conditions that a form’s value must meet (or not meet) to trigger another action to occur. Conditional Actions can also be entered for fields which are explained in the next section.
Conditional Actions – View/Edit
Clicking the View/Edit control opens the Conditional Actions window in the Form Builder body/grid as shown in the figure below.
The Conditional Actions window allows the Form Designer to create simple to complex validations or edit checks for the selected form. Please refer to the help pages for complete instructions about how to create Conditional Actions.
A “0” preceding the View/Edit control indicates there are no (zero) Conditional Actions for the form. For each Conditional Action that has been defined, the number that precedes the View/Edit control increments by one as shown in the following figures.
Data in the Form/Page Properties refers to Record Relations.
One – A relationship of “One” means the form is not related to any other form in the system and can be completed only once throughout the Study. An example is Procedure form. Only one procedure form usually is made.
Many – A relationship of “Many” means the form can be completed multiple times throughout the Subject record. An example is an AE or Deviation Form. Many AE's can happen per subject
Batch – A relationship of “Batch” means it can be filled out once as part of a group of forms. This group of forms (or batch) can be completed multiple times. For example, a batch form might be used if the research lab is conducting a study that involves receiving subjects in batches, rather than simply one at a time.
*Please note this batch relationship is mainly used in Animal Studies where you receive a "batch" of mice for example and you need to load them into the system at once to track the study progress.
- Enter the enrollment data
- Enter the Batch size
- Enroll new subjects to add subjects as shown below.
One to One Location – This choice selected from the dropdown list (Registration or Subject Record) determines whether the form populates the Subject Manager Registration page (the page displayed when the Subject Manager application is first opened) or the Subject Visits and Events Manager page which is accessed from the Subject Manager Registration page when a Subject ID link is clicked from the Subject Registration table.
Date Granularity – The Date Granularity selected from the dropdown list (Second, Minute, Hour or Day) determines the extent to which the date on the form will be specified in the database. The date the form is filled out can be recorded down to the day, hour, minute, or second.
Visit/Transaction Date – The Visit/Transaction date field is required only for Subject type forms created in the Study Form Builder due to the longitudinal nature of clinical trial data collection. The Study Form Builder requires a date field to be selected from the dropdown list which relates it to the Scheduled Visit/Event Forms Interval table displayed on the Subject Visits and Events Manager page (accessed from the Subject link in the Subject Manager Subject Registration data table). The field drop-down choices are populated with the Date/Time fields that appear in the form. The Visit/Transaction Date field does not appear in the Data Section of the Form/page Properties when in the Website Host Form Builder application.
Want to populate and hide visit/Transaction Date to users on the data entry screen?
- Select Compute Value on the date field on form to hide
- Pick any field to fire calculation [Any field [blank]]
- Choose Constant from options in CA
- Select Current Date from drop-down
- Hit Ok
Don't forget to save the form.
Now go to Study drop-down and select "Role Security" tab.
- Select Study drop down menu
- Select Role Security tab
- Select Role to edit
- Click on Blind Form Fields by Role (see fig 3)
- Save Study Configuration
To Blind Fields by Role, click the following link: Blind Form Fields by Role.
- Select Form to Blind Fields on from drop down
- Check fields you want to blind on that form
- Save Field Blinding
Log Form – Selecting the “Log Form” check box designates that a form can be completed multiple times. Log Forms can be created using the Study Form Builder. Subject Forms designated as Log Forms populate the Log Forms section of the Subject Visits and Events Manager page (accessed from the Subject link in the Subject Manager Subject Registration data table on the Subject Manager page). Study Forms designated as Log Forms populate the Study Forms page (accessed from the Subject menu using the Access Study Related Forms… link). The Log Form check box appears in Website Host Form Builder; however, the feature is not applicable to forms (User, Site, and Study) created in the Website Host, therefore, the feature is non-functioning.
Double Data Entry - Double Data Entry (DDE) has been designed into the Clinical Studio system. Even though the application is called “Double” Data Entry, you can actually perform double, triple, quadruple or quintuple data entry. The more times a form is entered, the less chance for data entry errors to occur. Double Data Entry is an industry accepted term and we will use it here as well. This feature of research studies was primarily used in the past for pen-and-paper studies.
Although it is not commonly used anymore, Clinical Studio has provided the option for using DDE. For complete instructions on the DDE system please see the DDE - Double Data Entry help document.
Interval Date Entry – Select this check box to allow for multiple date entries when interval visits are required in the study. Interval Date Entry, or IDE, allows a Study Designer to enable Data Coordinators (or someone with a similar role) to enter visit dates at the Visit Interval rather than on the actual form. IDE is designated on the Functionality tab in the Study Configuration application. Additional information about Interval Date Entry is available using the search function in the Clinical Studio Help system.
Suppress VOW – The Suppress Visit Outside Window checkbox can be selected to allow for visits outside the date window as specified in the Create Scheduled Visits application by the Study Designer. Many studies will have a scheduled subject visit table which defines specific visit intervals. Each of those intervals will have a window within which a visit must occur. If a subject visit falls outside the specified window, the system will deploy a Visit Outside Window query. Some studies will not require such queries to be produced. If that is the case for your study, then check this option.
Omit Error Msg – The Omit Error Msg checkbox can be selected to prevent an error message from displaying on the form, regardless of the reason the error message would have been fired.