Add instructional text

Study designers can now add instructional text to certain forms to provide users with additional information about how to complete a form and its questions.

Details for study designers

When it comes to creating forms, here's what's been enhanced in your workflow:

• Instructional text cannot be used in question groups, repeating forms, or repeating tables, including lab forms.

  Note:

  Instructional text can only be added to the top section of a two-section form.
• When you click Add in an appropriate form, the option to include a new question as instructional text is available for forms and can be added anywhere within a form.
• The added text can be formatted for further clarity, if desired. External links and email addresses can also be included.
• Once your study version is approved, the added instructional text can be modified or deleted.
• If the form only contains questions added as instructional text, it cannot be listed for signature configurations.

More information and step-by-step instructions on adding instructional text can be found in the Study Designer User Guide after the Release Assessment Environment (RAE) upgrade.

For information about how instructional text gets displayed in Archives requests, see Enhancements to Oracle CRF Submit archives and reports.

Details for site users

As a site user, there is no change to your workflow. However, be aware that forms may now include read-only instructional text inserted by sponsor users at the time they created a form.

Impact on reports

The Study Design report and Annotated Case Report Forms now include instructional text that has been added to any forms.