Administrative Files: Reviews will be conducted on the administrative protocol files housed in the Research Integrity Office to determine that the processes, procedures, and principles governing the activities and oversight of the RIO and the IRBs are reflected in the official documentation. Paper and electronic files are subject to review. Protocols selected for internal review will correspond with all files identified for an external Random Scheduled or Directed review (which will qualify as random selected for the internal review process). Directed reviews will be conducted at the request of the IRB. The review will utilize the QI Internal Review Worksheet.
IRB Meeting Minutes: Reviews will be conducted on randomly selected IRB minutes to determine that adequate documentation of the meeting discussion has occurred according to the applicable regulations and guidelines.
Results may impact current practices and may require additional educational activities, and will be reported to the Director.
Ongoing Quality Monitoring: Projects will be initiated to improve existing processes by identifying the root cause of a problem, developing and initiating an action plan, and evaluating the outcome to assure problem resolution. The goal is to educate RIO staff and to achieve standards of excellence in IRB practices.