8 Review and Sign Participant Records

e-Sign Participant Records

Data Specialists (a study-level role) and Investigators (a site-level role) can sign Participant records.

Participant records can be signed on an event-by-event basis or, once all events for a participant are in a final state, the complete Participant can be signed.

Data should be reviewed prior to signing. Steps to review and sign Participant records are listed below.

 

Sign Participant Records for One Event

If you are an Investigator or Data Specialist, you can sign an Event to indicate that all Forms have been reviewed and approved. 

Events must have a status of completed, stopped, or skipped before they can be signed. The Event cannot have been archived or removed. To sign a participant event, first review the data captured in the event, then change the status to signed.

To Sign a Single Event:

  1. On the Participant Matrix, click the Event you want to sign.
  2. Click the Sign button in the pop-up.

Or

  1. Click the View icon for the participant with an event you want to sign.

  1. On the Participant Details screen, for Visit Events, locate the Event you want to sign, and click the Sign button in the Event Actions column.

Or, click the Edit button in the Event Actions column to go to the Update Study Event screen. Then click the Sign button.

For Common Events, click the Sign button in the Actions column on the Participant Details screen.

  1. The Electronic Signature screen that includes an attestation, your full name, and a prompt to enter your username and password as your electronic signature appears.
  2. Scroll to the bottom of the page to see a list of Forms in the Event and the status of queries for each of those Forms:
  3. Enter your username and password and click submit to complete the electronic signature process. You return to the Participant Details screen. Note that the status of the event is Completed, but the Signed and Locked icons also appear underneath.

Sign Participant Records for All Events for a Participant

If all Events for a Participant are in a final state (Not Scheduled, Completed, Stopped, or Skipped), then the entire Participant record can be signed at one time. The Participant Matrix provides a signature icon for any Particpant whose entire record can be signed.

To sign for multiple Events for that Participant, click the Sign icon.

Multiple User Signatures

Multiple users can sign an Event, so even if an Event has already been signed, the Sign action will still be available. If there are multiple signatures, the most recent one appears on the Form, and the others appear in the Audit Log.

Unsigned Events

Events are unsigned if:

  • A user makes changes to an item on a Form after the Form was signed.
  • The Event status was changed from Completed, Stopped, Skipped or Not Scheduled after being signed. (This also changes the Participant status from Signed to Available and the Event Status to Completed.)
  • A user archives/unarchives the Form, unless the Form had a status of Not Started.
  • A user removes/restores the Form.

Note: Changing the version of a Form will only unsign the Form if a user changes data. 

 

 


Approved for publication by ktamm. Signed on 2021-01-22 10:50AM

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