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.