Create a form with one section

Forms hold all the questions you must ask subjects during a study. Standard forms should include questions that verify whether subjects meet eligibility criteria, such as whether a subject has signed an informed consent document or whether the subject is eligible for being enrolled in a rollover study.

Depending on the types of data that you want to collect, you can create questions that are used to collect relevant and valuable data for subjects. You can also create questions that help site users collect data that enhances the dispensation and randomization process. For example, you can create a question to collect a value that determines the stratum groups subjects are randomized to. Or you can create a question that collects the required value to calculate a subject's dose of the investigational product.

You'll create the calculated doses when you create kit types.

You'll create the stratum groups when you create a randomization design.

Note:

Multiple study designers can create or update different forms at the same time. For example, you can edit a form, while at the same time another study designer creates a new form. However, you are not allowed to work on the same form at the same time. If you try to open a form that another study designer is working on, the system displays a message informing you that another user is editing the form at that moment and you can only view the form. For more information, see Can multiple study designers edit a study at the same time?.

To create a form with one section:

1. Access the Draft version of a study as described in Open a study's design.
2. Make sure you are on the Data Collection tab.
3. Click Create Form and select 1 Section from the drop-down.
4. In the field located in the upper left corner, enter a name for the form.
5. On the right, expand the Details pane and make sure the following settings and fields are configured as expected:

   Field or setting	Description
   Reference code field	Make sure the form has a reference code. A reference code is a one-word abbreviation for the form.
   Repeating Form toggle	The Repeating Form toggle is turned on, by default.

   Tip:

   As you create a form, consider documenting the test cases for its questions.
6. Create questions for the data that you need to collect. For more information on the available types of questions, see Question types and settings.
7. Click Save or Save & Close.