13.5 Participate and the Audit Log

When Participants enter data in a form from the Participant Dashboard, the data that is entered is tracked in the Audit Log and the Participant is listed as the user who performed the action. No personally identifiable information is presented in the audit log. The participant is identified with a user identifier structured as follows:

StudyOID.environment (test or prod).SS_OID

For example, in a Study named Juno, in the Test environment, Participant OHIO-1705 is identified as:


All actions performed by the Participant are recorded in the Audit Log.

These actions include:

  • Entering data
  • Changing Event Status
    • When a Participant starts entering data into a form, the Event Status changes to data entry started
  • Changing Event CRF Status
    • When a Participant selects Let's Move On, the Event CRF Status changes to complete

In the following example, in the Juno study:

  • A CRC invited a Participant and scheduled an event containing a Participate form
  • A Study Participant (with a coded identifier of S_JUNO.TEST.SS_OHIO1705) started data entry for the Event
    • Each value entered is logged and attributed to the Participant
    • The Event Status change is logged and attributed to the Participant
    • The Event CRF status change is logged and attributed to the Participant

 Participant Audit Log

Approved for publication by Paul Bowen (pbowen), Director of Product. Signed on 2020-03-04 7:35PM

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