Study documentation FAQs

What types of study documentation are there?

Study Design—A set of instructions and other details about forms, data items, and edit checks.
Protocol Guide—A copy of the sponsor’s study protocol, formatted for online viewing.
Visit calculator—A list of suggested visit dates based on a start date and the schedule in the study design. You can edit the start date to recalculate suggested visit dates.
Sample Book—A complete set of read-only blank forms that you can use to familiarize yourself with the layout of the forms and visits.

Why can't I see the study documentation?

Some sponsors include study documentation on the Home page for a study. In addition, study documentation is optional and might not be implemented for your study.