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