Internal Quality Improvement Program Overview

Purpose:

To assess and assist the Principal Investigator (PI) in assuring the rights and wellbeing of human subjects are protected and that the study is being conducted in accordance with IRB requirements, the approved protocol, applicable Federal regulations, University policies and best practice (GCP) standards.

Goal:

To provide education and feedback, when necessary, and to prevent situations that might place additional risks on human subjects or lead to regulatory citations if the research were to be reviewed by an outside entity.

Types of Reviews and Selection Process:

Routine reviews include a sampling of human subject research selected and conducted in departments across the University. The selection process is based on such factors as study risk, enrollment of vulnerable populations, and the degree of external oversight.

Directed(For Cause) reviews are those studies identified by the IRB and requested to provide an assessment of compliance with the approval requirements and may be focused on one aspect of the research (such as the consent process) or a broader review.

Requested reviews are those that are not routine or directed and may include but are not limited to:

1. A request by any member of the research team in support and preparation for an external audit by a federal agency (NIH, FDA, OHRP) or sponsor, or
2. A request in support of a PI (new or experienced), study team, or department.

(These reviews are conducted within the limitations of available resources.)

How the Program Works:

Memo: The PI will receive a memo indicating the intention for the review and requesting that the PI select a time and place for the review to be conducted. Investigator may assign a person to arrange access to the records and space for the review.

Onsite Review: The parameters that may be examined include, but are not limited to:

• Study File for required elements including: all versions of the approved protocol, consent forms and IRB approval documents.
• Subject eligibility
• Informed Consent Process Documentation
• Adherence to the protocol
• Data accuracy
• Adverse event / Unanticipated event reporting
• Confidentiality of records
• Data Safety Monitoring Plan
• Drug and Device handling and accountability (if applicable)
• Site specific SOP's (if applicable)

The scope of the review is based on considerations such as the trial objective, purpose, design, complexity, blinding, enrollment and endpoints of the trial. Depending on the size of the trial, sampling may be an acceptable method for selecting the documentation/data to be verified. All reviews are conducted in a confidential and collegial manner. If deficiencies are found during the course of the review, they will be brought to the attention of the investigator and/or study staff and considerations for process improvements and assistance with preventative action plans is offered.

Exit Interview: Following the review of study documentation, the reviewer meets with the PI and any members of the study team (at the PI's discretion) to discuss the preliminary findings and provide the opportunity for immediate dialogue, feedback and/or clarification as well as process analysis, recommendations and education.

Draft observations: The PI receives the draft observations electronically and is asked to provide feedback and a preventative action response for each observation within a defined time period.

Final Report: The PI's response is copied into the final report and distribution is limited to the PI and others who may be responsible for action on observations.