Data exports

You can export data in any language that is supported in the study. Typically, you create a data export file at the end of a study. You can export study data to the following formats:

• PDF file, which may contain:
  • Title page identifying the client server, study name, PDF Type selected, and the date of the export.
  • Configuration selections made on the Export Data page.
  • If PDF Type is Patient: Patient ID, initials, and arm.
  • Patient Status history.
  • Table of Contents with links to the data included.
  • Each visit, including a Visit Status History and Form Status History for each form within the visit, including completed, incomplete, and forms with queries and the forms themselves.
  • Images of completed forms for all or some sites. Each form begins on a new page.
  • A complete audit trail for each data element following each form and including the actual value, when it was recorded, who recorded it, and (if the functionality is implemented for the study) the reason for each change.
  • An audit trail of patient transfers that includes the date and time of the transfer.
  • All of the repeating sections or instances of forms.
  • All queries associated with each data element and the full history for each query.
  • The patient ID, visit, and form names in the header of each page.
  • The date the PDF was generated and the page number in the footer of each page.
• Microsoft Excel spreadsheet software file, which may contain:
  • A complete audit trail for each data element, including the actual value, when it was recorded, who recorded it, and (if the functionality is implemented for the study) the reason for each change.
  • All of the repeating sections or instances of forms.
  • All queries associated with each data element and the full history for each query.
  • The subject ID, visit, and form names.
  • The date the file was generated in the automatically generated filename.

Note: If the study is designed to contain Personal/Protected Health Information, and designers and sponsors choose to encrypt it, they have the ability to indicate which items on forms contain sensitive information that should be encrypted and also excluded from email messages, data exports, and reports by default.