Contact Information

Organization

THE QUALITY IMPROVEMENT UNIT (QIU)

• Overview of Activities
• On-Site Review of Clinical Research - Selection of Protocols
• CHR Audits and Post-Approval QA Activities
• Research Participant Complaints
• On-site Assessment and Training for Investigators and Research Staff
• Indirect Monitoring of Clinical Research
• Reporting
• Frequently Asked Questions
• Clinical Research Tools, Checklists and Templates
• Staff and Contact Information

OVERVIEW OF ACTIVITIES – Revised January 2005

Introduction

The Quality Improvement Unit (QIU) is a newly formed unit of the Human Research Protection Program (HRPP). The main missions of the QIU are post-approval monitoring, education/training as well as other quality improvement (QI) activities. The primary role of the QIU is to monitor the conduct of clinical research to assure the rights and welfare of human research participants and to optimize adherence to federal regulations, state laws, institutional policies, and research protocols approved by the UCSF Committee on Human Research (CHR).

QIU activities include the following:

	•	routine on-site reviews and directed (for-cause) investigations of clinical research studies
	•	indirect monitoring of clinical research activities through processing of adverse events, violations and incident reports submitted to the CHR
	•	ongoing HRPP/CHR internal QA and QI activities
	•	management of non-routine participant complaints and concerns
	•	investigator requested on-site assessment and training of clinical research personnel

On-Site Review of Clinical Research - Selection of Protocols

Given the large number of active clinical research projects at UCSF, it is not possible for the QIU to review each protocol. QIU on-site review activities will focus primarily on studies that do not undergo some degree of formal routine on-site monitoring.
Protocols will be selected for QIU review or investigation based on either “Routine” or “Directed” criteria as described below:

Routine QIU Review

	•	A Principal Investigator (PI) requests a review.
	•	A study is an IND or IDE investigator-initiated, department-sponsored, and/or industry-sponsored, and does not have provision for on-site monitoring.
	•	The QIU randomly identifies a study for review as part of routine HRPP Quality Assurance activities.
	•	A study is working with a vulnerable subject population (i.e., surrogate consent, minors, etc.) or the study design has a potential for increased risk to study volunteers (i.e., phase I trial, gene therapy, etc.)

Directed QIU Investigations

The QIU conducts Directed Investigations at the request of the CHR for reasons including, but not limited to:

	•	Investigator has history of poor adherence to CHR policies and procedures.
	•	The HRPP receives an internal complaint or concern (i.e., from a research participant or family member, UCSF personnel, or other UCSF entity).
	•	The HRPP receives an external complaint (i.e., from OHRP, the FDA or a sponsor) of potential protocol violation or regulatory non-compliance.

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CHR Audits and Post-Approval QA Activities

The QIU conducts periodic, routine QA audits of the CHR to assess compliance with federal, state and UCSF policies, identify areas for improvement, and to suggest remedies based on existing policies/procedures and current or projected staffing levels.

The QIU processes and manages all adverse event, protocol violation and incident reports submitted to the CHR.

Research Participant Complaints

The QIU manages (and investigates as appropriate) all serious, non-routine human participant complaints (i.e., complaints of study-related injury, safety concerns, violations of participants’ rights or problem about past research participation, etc).

On-site Assessment and Training for Investigators and Research Staff

The QIU conducts on-site assessment and training when requested by a UCSF affiliated investigator, their study personnel or the CHR.

Indirect Monitoring of Clinical Research

The QIU compiles and assesses existing monitoring and reporting data that have been generated via Data Monitoring Committee or DSMB reports, or cooperative/collaborative audits (i.e., NCI, CALBG, CVRI, VAMC, etc.)

The QIU monitors publications of UCSF investigators to ensure that proper IRB approvals were in place for these studies.

Reporting

Based on findings from on-site routine reviews and directed investigation activities, the QIU provides the CHR with:

	•	Documentation, analyses and reporting of investigatory findings
	•	Recommendations and corrective action plans
	•	Construction and/or revision of HRPP guidance
	•	Development and tailoring of educational materials and training programs
	•	Recommendations regarding CHR policy in collaboration with senior HRPP personnel and CHR panel Chairs