Sign at the visit level

If your study requires you to sign data for visits then you must perform this task to ensure that the data is accurate.

Before signing off at the visit level:
  • You need the Approve and sign subject data permission to sign a subject's data.
  • If changes are made to signed data, the data becomes unsigned and requires re-signing.
  • Be aware that it may take up to 60 minutes for signature request details to become available once visit data for a subject has been entered.
To sign off on a visit:
  1. On the Home page, determine where to work. For more information, see Access study modes and pages.
  2. Along the top, make sure Subjects is selected, and that you're on the Subject Overview view.
  3. From the Review filter, select Ready to Sign to filter your search for subjects with visits that need to be signed.
  4. If you're assigned to more than one site, filter your view based on country and site. For more information, see Filter subjects in a study.
  5. In the subjects list, locate a subject, and select the checkbox to the left of the subject.
  6. On the Signature Request sidebar, select Sign for the visit that requires your signature.
    The system opens the Visit window.
  7. On the Signature Request sidebar, click Select for the visit that requires your signature.
  8. Perform one of the following:
    • Select Sign to sign for the selected visit and sign another.
    • Select Sign & Close.
  9. In the Sign Data dialog, read the affidavit.
  10. Acknowledge the affidavit by entering your Username and Password, then select Sign.