Continuous Quality Improvement

To maintain excellence in the protection of human subjects and to meet federal and Association for the Accreditation of Human Research Protection Programs (AAHRPP) requirements, a successful monitoring program is essential. At USC, the Quality Improvement program serves to keep investigators cognizant of rules, to correct procedural errors, and most importantly, to increase protections for subjects enrolled in research projects. Quality Improvement procedures include assessing investigator compliance with the IRB, monitoring the IRB review process, and inspecting study records and documentation.

Quality Improvement Tools & Results

Not-for cause, non-putative auditing tools:
Pre-visit Assessment
Site Visit Guide
CQI Interview Questions

Lessons Learned from CQI Assessments
Problems Frequently Identified During an Audit/Assessment 
Continuous Quality Improvement Visit Tip Sheet

Continuous Quality Improvement Efforts

BioIRB Audit Checklist 
SBIRB Audit Checklist

Study Documentation Templates

Biomedical Study Binder Contents (Regulatory Folder)
Socio-Behavioral Study Binder Contents
Sample Checklist for Documenting Subject Visits
Clinical Trial Feasibility Assessment Tool