Contact Information

Organization

THE QUALITY IMPROVEMENT UNIT (QIU)

• See also: QIU Overview of Activities
• See also: Staff and Contact Information

FREQUENTLY ASKED QUESTIONS ABOUT THE QIU - Effective February 2005, Revised June 2006

What is QIU?

Along with the Committee on Human Research (CHR), the Quality Improvement Unit (QIU) is second main unit of UCSF’s Human Research Protections Program (HRPP). The purpose of the QIU is to provide information to faculty and staff on regulatory compliance and Good Clinical Practice (GCP) Guidelines related to human research participants, data collection and data management; to verify that safeguards protecting the rights and welfare of human research participants are met; to verify investigator adherence to the study design as approved by the CHR protocol, and applicable regulatory requirements; and rarely, to investigate complaints and/or allegations of noncompliance with research regulations.

What QIU can do?

	•	Conduct routine, proactive, on-site review
	•	Conduct directed investigations
	•	Assist investigators in performing site or study-specific self-assessments
	•	Conduct post-approval monitoring of research activities
	•	Provide consultation to research sites and study personnel
	•	Provide the CHR with information about the post-approval conduct of studies
	•	Assist with submission of initial study applications to the CHR

Are QIU personnel available to provide education and training?

Yes, QIU personnel are available to provide both individual and group training sessions.

What is the purpose of a routine, on-site review?

	•	Provide post-approval educational opportunities to research professionals
	•	Assist investigators with self-assessment tools and processes
	•	Verify that the rights and safety of participants in clinical studies is or has been properly protected
	•	Assess adherence to Federal Regulations/Guidelines
	•	Assess adherence to the CHR Policies/Guidelines
	•	Recommend corrective action plans for problems identified during site reviews or investigations

How does the QIU select protocols for a routine on-site review?

Protocols are selected randomly for a routine on-site review by performing a query of the CHR database. Fields that may be included in the query are:

	•	Investigator-initiated IND or IDE (investigators must meet both investigator and sponsor regulatory requirements)
	•	Absence of formal on-site monitoring activities
	•	Source of funding
	•	Relative degree of potential risk to participant or non-adherence to regulatory requirements, University policies or CHR guidance (based on expected adverse events, type of study, or vulnerable study population(s))

Who conducts routine on-site reviews?

Routine on-site reviews are conducted by QIU personnel. The QIU is a multidisciplinary team comprised of healthcare professionals who have experience in conducting, managing and/or monitoring clinical research studies.

Does the PI need to be present during the entire on-site visit?

No, the study PI does not need to be present during the entire routine on-site review or directed investigation. However, it is usually requested that the study PI meet with the QIU staff prior to and at end of the review or investigation for an interview. The PI may also be asked to be available via pager or to check in periodically with QIU staff during the visit to answer any questions that may arise.

What information is reviewed during a routine on-site review or directed investigation?

The scope of review or investigation may vary depending on a number of factors. All site reviews or investigations will be preceded by a Notification Letter from the QIU that includes specific details about the precise Scope of Review. The Scope of Review may include some, or all of the following items:

	•	The approved research protocol and all CHR correspondence
	•	The informed consent documents and the informed consent process documentation
	•	Recruitment, screening and enrollment process and procedures
	•	The Regulatory Binder and affiliated study correspondence
	•	Adherence to the inclusion/exclusion criteria
	•	Adherence to study procedures
	•	Occurrence and reporting of adverse events and protocol violations or research-related incidents
	•	Drug and device accountability tracking forms/logs (if applicable)

What should I do if I identify problems when preparing for the on-site visit?

If any errors, omissions or other problems are identified while preparing for an on-site review, please notify a QIU Program Coordinator for guidance. The most frequent advice that is given if errors or omissions are discovered is to document the event in the participant’s medical record and place a signed dated memo regarding the event in the research file (known as “note to file”). A report describing this event should also be submitted to the CHR along with a plan of corrective action to be taken to eliminate future occurrence of this problem. See the HRPP website for the appropriate forms for reporting various events.

What information should be available for an on-site visit?

	•	Informed consent documents for all persons screened and/or enrolled
	•	Screening/enrollment logs
	•	Each research participant’s study binder/file
	•	The regulatory file/binder (should include all correspondence involving the investigator, CHR, regulatory entities, sponsor and DSMB activities/reports)
	•	Drug and device accountability documentation, if applicable

Who receives a report of the routine on-site review or directed investigation findings?

On completion of a routine on-site review or directed investigation, the QIU staff will draft a report of their findings and send it to the Principal Investigator and the Co-Investigator.

For routine site reviews in which no serious or reportable problems are found, the report of findings is sent only to the study PI/Co-PI and other leading site staff and the findings are not shared with the CHR panel overseeing the protocol review. For other types of review (i.e., directed investigations) or if there are serious or reportable findings from a routine on-site review, reports are shared with the CHR panel overseeing the research project and copies of the report may be distributed to some or all of the following individuals and agencies:

	•	Department Chair
	•	Committee on Human Research
	•	Associate Vice Chancellor, Research
	•	Executive Vice Chancellor
	•	Regulatory and/or Funding Agency

What problems may be identified during an on-site review or investigation?

Top five deficiencies cited in FDA audits:

	1.	Failure to follow the protocol
	2.	Problems with the Informed Consent Form or the Informed Consent Process
	3.	Failure to keep complete and accurate records
	4.	Failure to account for the disposition of study drug
	5.	Failure to report adverse events
	(Research Practitioner, 2004)