When you sign a Subject casebook, which is also referred to as the complete Subject record, you provide your approval of all CRF data for all Study Events for the Subject.

  1. To sign the casebook, no Events for that Subject can have a status of “scheduled” or “data entry started.” When that is true, the Sign icon is listed in the Actions column for that Subject. Click the Sign icon.
  2. The Sign Subject page opens, showing links to all information for the Subject for the Study; click any link to review the information. The page also presents a statement about what signing the Subject record signifies.

    Sign Subject

  3. Enter your user name and password in the appropriate fields.
  4. Click Submit.
    The Subject Matrix opens, showing the status for all Events as signed.