Creating a Form

Forms will hold your Items for Data Collection. A Form may contain one or more Items within it. The Items will be grouped into one or more Item Groups.

You can create Forms in CRF Design > Study Library module > Library > Forms section.

Open

From the Forms Library page, you can use the Action menu to import or create Forms:

Open

Click “New” to create a Form, a “Save Form” popup screen will open. In this screen you can define the following:

• Name - define the name of your Form.

• Description - add an optional description. This will be displayed in the Description column on the Form Library Home page.

• Help Text - provide some optional help text, guidance, advice for users who will be collecting the Form. More Help Text can be added for individual Item Groups and Items.

• Common Form tickbox - you will need to tick this box, when creating a Common Form (for example, the AE/CM Form).

• Disallows Scheduled? / Disallow Unscheduled? - you can use these tickboxes to disallow scheduling them in Activity Plans and adding them as Unscheduled Forms during data collection.

• ICF Requirement - you can choose amongst the configured ICFs (Primary and Secondary) to define an ICF requirement for the Form collection. When an ICF requirement is defined, the users will not be able to collect the Form for a Subject, unless the required ICF had been documented.

• Barcode Verify - you can add a Subject Barcode verification step to each Form. This could be useful for Sample or Dose Forms.

• Deviation Pre-Window / Post-Window - these settings define the allowable deviation windows for all of the items within a Form. This setting would rarely be used, the more often used Time Windows are configurable on the Activity Plan level.

• Timepoint Offset Seconds - you can use this to define the Offset from the specific Timepoint in seconds (when you wish to schedule several Activities for the same Timepoint and order them according to their allowable collection Time Window).

• Create Item Group - If the Form and at least one of the Item Groups within the Form are called the same, you can tick the “Create Item Group” tickbox and ClinSpark will create the Item Group for you.

• Base Type - Some Forms can be defined as Base Forms, you will be able to select the Base Type for the Form in this dropdown.

In the Form you can create one or more Item Groups.