159 Good Clinical Practice training assignment and tracking completions improvement project

Abstract

OBJECTIVES/GOALS: We will reduce the number of research staff by 50% within 6 months that are non-compliant with completing the Good Clinical Practice (GCP) course without increasing costs as measured by salary and benefits for staff involved in the tracking and assignment process. We will also introduce a GCP policy to define the education requirements for GCP training METHODS/STUDY POPULATION: We touted focus groups to stakeholders for input on workflows with graphs, surveys, and meetings in the onset and throughout the project. This input prompted us to develop a staff guide outlining the modification process of removing a staff name from an IRB trial if they are no longer active in the trial. A workflow and root cause analysis were done resulting in the implementation of one gatekeeper for assigning and tracking completions, instead of three staff. Successfully reconciling the non-compliant report, which extracted data from three databases, allowed us to eliminate 174 names from the report, which originally comprised 792 names. IRB modifications were entered into the IRB system for these 174 names. We also put into effect a GCP policy for the institution, where none had previously existed. RESULTS/ANTICIPATED RESULTS: * In 3.5 months, we decreased the GCP non-compliance rate by 50% from 792 to 399. * We removed 22% of names from the 792 from the report due to their status of being non-employees, or Emeritus, or not in research anymore. * We discovered a data type issue in the non-compliance report that shuffled the MAX calculation, therefore not requiring some staff to complete the training. * We developed a new process for assigning training, resulting in faster compliance rates for the institution. It included sending emails to users two months before their training expired before we assigned the course to them. * We reconciled the non-compliance report, and it decreased the effort with staff involved in GCP for grant renewals and audits in numerous other departments. * Developed an escalation procedure for non-compliant staff. DISCUSSION/SIGNIFICANCE: Failure to address our GCP non-compliance rates could have put our institution at risk for potential penalties. With 4400+ research personnel listed on active trials the interventions we implemented accelerated our compliance rate by assigning the refresher course monthly and this also resulted in no disruption to staff completing the training.