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 The Event cannot have been archived or removed.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.

 

Click the Sign button in the Event Actions column on the Participant Details screen.

 

or

 

Click the Edit button in the Event Actions column on the Participant Details screen. On the Update Study Event screen, click the Sign button under Other Actions.

Note: If an Event is signed, changes to an item in a Form in that Event removes the signature. This also occurs if an Event status is changed from completed, stopped, skipped or Not Scheduled after being signed. In addition, this changes the Participant Status from signed to available and the Event Status to completed.

Archiving/unarchiving or removing a Form will unsign the Event. The exception is that when archiving/unarchiving, a Form with a status of Not Started will not be unsigned.

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.

 

  1. On the Participant Matrix, click the view icon for the participant with an event you want to sign.

  2. On the Participant Details screen, for Visit Events, locate the Event you want to sign, and click the Sign icon in the Event Actions column to review the data on the Form.

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 icon in the Actions column.

4. An electronic signature page displays and includes an attestation, your full name, and an option to enter your username and password as your electronic signature.

5. Scroll to the bottom of the page to see a list of forms in the Study Event and the status of queries for each of those forms:

 

6. Enter your username and password and click submit to complete the electronic signature process. You return to the Participant Details page. 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.


Approved for publication by ktamm. Signed on 2020-09-11 2:29PM

Not valid unless obtained from the OpenClinica document management system on the day of use.