This webinar provided information about the progression of quality assurance/quality improvement (QA/QI) study reviews, beginning with the selection of the study or focus for review, continuing through the process of reviewing the institutional review board (IRB) or the investigator, and concluding with possible uses for the results.
Topics for discussion included:
- Introducing different types of QA/QI reviews and selecting studies for site visits:
Presenters focused on the role of the IRB in general or topic-specific reviews and the responsibilities of the investigator and research staff in routine and for-cause site visits.
- Reviewing the IRB:
Our speakers discussed when review of the IRB should be conducted, and what specifically needs to be reviewed, by whom, and how frequently.
- Reviewing the investigator:
What happens during a site visit? Presenters covered investigator interviews, record reviews, exit briefings, and opportunities for investigator education, and other research compliance areas.
- Assessing and handling the results:
Our speakers discussed lessons learned and ways to use the feedback from completed reviews to improve the human research protection program (HRPP) as a whole.
This special webinar may be of interest to individuals working in human subjects protections, specifically, in QA/QI, HRPPs, and IRBs.