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

Events must have a status of completed before they can be signed. To sign a participant event, first review the data captured in the event, then change the status to "signed."

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

  2. On the Participant Details page, locate the Event you want to sign.
  3. In the Actions column for that event, click the view icon for each form to review the data on each form.

  4. Once all forms have been reviewed, in the Event Actions column, click the edit icon.

  5. In the Status drop-down list, select signed and then click Submit Changes.

    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.

    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:

    If there are open queries on forms, you may want to wait to sign the form or click the view icon to view all the data and associated queries for each of the forms.

  6. Enter your username and password and click submit to complete the electronic signature process.

    You return to the Participant Datails page. Note that the status of the event is signed.

When you return to the Participant Matrix, the icon indicates the event has been signed for that participant.

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 signature stamp icon. Scroll down to review the forms for the Participant. A count of all queries is provided for each form. If there are New or Updated queries, you may want to postpone signing the record until those queries all have a status of Closed or Closed Modified (meaning that the data changed after the original query had been set to a status of closed.)