Summary

This article shows you how to create a basic visit containing several forms with a variety of questions.

Table of Contents


In many clinical studies, the patients are studied over a period of several visits, and are subject to different examinations, tests, dose administrations, and other things at each visit. The Fountayn clinical research platform allows the eClinical Trial Designer to quickly and efficiently create a number of visits in a short period of time. After completion of this tutorial, you will know how to create a basic visit containing several forms with a variety of questions. This tutorial assumes you have already completed the first tutorial, Creating Your First Form.

Concepts Covered

This tutorial covers the following topics:

  • Creating Form and Visit
  • Creating Questions
  • Configuring a Study

Step 1: Open the DataArchitect Template

Any brand new study requires you to start with a fresh version of the DataArchitect template. Only in certain cases would you start from an existing study, such as when a sponsor requests a very similar study or extension of a previous one.

Step 2: Create a Container Form for your Visit

Container forms are those that don’t have any questions themselves, but rather just contain a list of several child forms. Many times the forms that indicate the visit are container forms, such as Screening, Baseline, Week 2, etc.

Since there will eventually be several visits in this study, you will create a generic Visit form to be used (and renamed) in multiple locations. You will do this in the same fashion as the Enrollment form in the first tutorial. Go to the FormTypes worksheet and enter visit for the formTypeId and Visit for the Form Type Name.

In this tutorial, the first visit will be the Screening visit. Once you have entered the information on the FormTypes worksheet, go to the Forms Template worksheet and enter the following information:

  • formId: screen
  • formTypeId: visit
  • Form Name: Screening Visit
  • Parent: record

Step 3: Create some Basic Screening Visit Forms

Now that you have a container form, you want to create some child forms underneath it. These will be the ones that contain our data, the ones analogous to paper CRFs. Typical forms you might see at a Screening Visit include Enrollment, Demographics, and Inclusion / Exclusion Criteria.

First, create these forms on the FormTypes worksheet, in the same way that you created the visit container. Use values of sc, dm, and ie for the formTypeIds of the three forms. Next, on the Forms – Template worksheet, you will want to add these forms with the parent set to screening, not record.

Step 4: Enter Questions for the Enrollment Form

Once you have created the forms you want for your visit, you’ll need to add questions. We can create Enrollment form questions similar to the ones seen in the previous tutorial, Creating Your First Form.

Note: When you are finished creating new question types, don't forget to add them to the Question Layout and Display worksheets.

Step 5: Enter Questions for the Demographics Form

The Demographics form gives us the opportunity to introduce a new Data Type and new Display Type. We will use a Data Type of Date and display type of RadioCheckbox, in addition to the ones previously introduced.

The Date Data Type is exactly what it sounds like. That is, most times you have a question about the date or time a particular event occured, you will use this Data Type. Date questions look just like String questions, except that they have a calendar helper tool, and only allow valid dates to be entered. Please note that you must enter a Date Format and Invalid Format Alert for date questions.

The RadioCheckbox Display Type is used when you want the user to pick from a list of options (such as race or gender), and also want to allow them to uncheck their selection if desired. This Display Type will also only allow one option in the list to be checked. RadioCheckbox questions require the use of Answer Options in order to function. These follow the format storedValue||displayedValue::storedValue||displayedValue. The :: separates answer options, and there can be as many as you need.

Using this information, you can create some of the standard questions on a Demographics form. Write these questions directly below the Enrollment form questions on each worksheet. In fact, it is a best practice to keep each worksheet in the DataArchitect in the same order that the questions and forms will appear to the user in the application. This helps with design, maintenance, and testing. For now, just copy the information directly from the screenshots below.

As always, don’t forget to add the questions to the Question Layout and Display worksheets, or they won’t appear on the form.

Step 6: Enter Questions for the Inclusion / Exclusion Criteria Form

The Inclusion / Exclusion Criteria form is a fairly standard form that usually consists of an Informed Consent Date question, a list of Inclusion and Exclusion criteria, and a final Is the subject eligible question. Depending on the study, more complicated questions can be used.

Begin by creating the Informed Consent Date question. This will be a Date Data Type question that appears at the top of the form. Don’t forget to give it a Date Format and Invalid Format Alert matching the Date of Birth question on the Demographics form. It is a best practice for all Date questions to have the same format and Invalid Format Alert.

Next, you will create a series of basic Inclusion / Exclusion Criteria questions. These are all Yes/No RadioCheckbox questions. For the question text, you can just copy the information from the screenshots below. Once you have all the Inclusion / Exclusion Criteria questions created, add them to the Question Layout worksheet.

Inclusion and Exclusion Criteria are typically separated into distinct groups on the form, with Group Titles indicating the section name. This is done on the Display worksheet, as before. Instead of only creating one Group Title at the top of the form, enter an appropriate Group Title for the first Inclusion and the first Exclusion question. This title will appear directly above the question in the application. In addition, you can add instructional text in this area, such as what is defined in the screenshot of the Display worksheet.

Step 7: Configure the Study

Any time you are creating a study from scratch for the first time, the last configuration step before you want to view the study involves the Application Setup and App Properties worksheet. These worksheets contain information about the study’s name, duration, date format, and Trial Summary. This study will be configured similar to the study created in the first tutorial.

First, go to the Application Setup worksheet and enter the following information:

  • recordName: Subject
  • recordNamePlural: Subjects
  • primaryQuestion: #screen1.sc.subjid
  • secondaryQuestion: #screen1.sc.subjinit
  • initialFormToDisplay: #screen1.sc

Next, go to the App Properties worksheet and enter the following:

  • study: TutorialStudy
  • studyStartDate: 01-JUL-2008
  • studyDateFormat: dd-MMM-yyyy
  • studyDuration: 4
  • studyDurationUnit: month
  • mostOftenAlertedCount: 10
  • mostOftenQueriedCount: 10
  • queriesOlderThanDays1: 14
  • queriesOlderThanDays2: 7
  • visitOutlook: 5

Leave the other fields at their default settings.

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In Conclusion

After completing this tutorial, you should feel comfortable in the following topics:

  • Creating Form and Visit
  • Creating Questions
  • Configuring a Study

Now that you’re armed with this information, we suggest you take the next tutorial: Creating Visits (Part 2).

Need more help?

Please visit the Fountayn Contact Information page.Creating Visits (Part 2)