QA/QI

Common Findings

The Quality Assurance / Quality Improvement (QA/QI) Program audits and/or monitors human research activities at USF and its affiliate partners for adherence to federal regulations, state laws, and institutional policies and procedures governing human research protections. Our activities focus on the following key areas:

  • IRB Approval Continuity
  • Informed Consent Process
  • Adherence to the IRB-approved Protocol
  • Unanticipated Problem & Adverse Event Reporting
  • Regulatory Records Maintenance
  • Research Record Storage