Tom Smith, a Study Coordinator at Site A in your clinical study, retired from the project three months ago. Due to a communication snafu, your clinical staff forgot to remove Tom’s name from the roster of active system users of the project’s IRT system. Two months later, your company’s QA group discovers this fact during their bi-annual production audit of the IRT vendor. From a regulatory perspective (not that they don’t trust Tom, honest!), they have to be concerned about the potential for unauthorized data changes…and about the fact that someone no longer assigned to the project could continue to view production data. How to quickly put all issues and concerns to bed?
Veracity Logic’s IRT provides access to its robust audit trail in two ways: interactively, at the level of each item, and via a ‘global’ audit trail which maintains the cumulative record of all data changes that have occurred on a given project. The VLIRT® audit trail captures the old and new data, timestamp and date of change, user making the change, and a justification (required) for the change. A quick query of the global audit trail will reveal any data changes made by Tom Smith subsequent to his date of departure. The system also captures the last login date/time for Tom. QA can rest easy when it sees that Tom last logged into the system prior to his departure date.
Want to hear about other ways Veracity Logic’s IRT can help solve project problems?