HSPP Quality Assurance and Quality Improvement (QA/QI) Program

Purpose

The HSPP Quality Assurance and Quality Improvement (QA/QI) Program at Children’s Hospital Los Angeles is committed to elevating research quality while prioritizing the rights, safety, and well-being of human participants. By fostering collaboration among stakeholders and driving continuous process improvement, the program fortifies the ethical foundation and integrity of all clinical research conducted at CHLA.

QA/QI is dedicated to upholding the highest standards of integrity in clinical studies, strictly adhering to federal and state regulations, ICH GCP guidelines, local requirements, established SOPs, and sponsor protocols.

Core Offerings

• Conduct Audits: Perform routine and voluntary reviews, as well as directed (including for-cause) audits to ensure compliance with ethical standards and regulatory requirements.
• Provide Education and Training: Deliver tailored training and educational resources to research staff to promote best practices and enhance the quality of study conduct.
• Post-Approval Monitoring: Conduct thorough evaluations of approved research activities to identify areas for improvement and enhance adherence to protocols. QMC particularly focuses on post-approval monitoring for studies lacking external sponsor monitoring (such as investigator-initiated trials or studies).

Contact information: qualitymanagementcorehelp@chla.usc.edu