49 - A Quality Monitoring Program at Advocate Aurora Research Institute

Background: The quality program at our Research Institute (AARI) seeks to ensure the protection of research participants and data integrity, proactively identify and correct problems, provide feedback and education, recognize, and commend best practices, and identify trends for quality improvement.

Program

Description: The purpose of the quality assurance activities through CQAIR is to ensure a consistent focus on ethical, compliant, and high-quality research and maintains a constant level of preparedness for review and inspection. The program serves as a quality resource for teammates and leaders engaged in research activities and those responsible for monitoring research activities, establishes quality metrics and maintains a research quality dashboard to demonstrate performance trends. The AARI quality program provides for periodic and systemic examination of compliance with the research protocol, regulations, and policies to protect subject safety, ensure data integrity and support research billing compliance. The quality team develops monitoring plans each year, and quality monitoring activities and trials are identified and prioritized based upon established risk characteristics. Stakeholders are asked to provide input on high-risk areas or processes that should be assessed. Routine quality reviews are intended to be educational and collaborative in nature to help correct potential problems, prevent noncompliance, and mitigate risks. Monitoring may also include for-cause reviews to investigate a possible risk to subject safety, validity of study data or noncompliance.
Quality monitoring for research billing is structured to ensure research claims meet all Medicare requirements and guidelines for clinical trial billing; to mitigate the risk of fines and penalties per the Federal False Claims Act and avoid erroneous bills to patients.
All quality monitoring activities are documented and reported out to individual study teams and stakeholders. Observations from quality monitoring review reports are summarized and presented to CQAIR and other stakeholders in aggregate on a quarterly basis, and any need for process improvement, corrective and preventive action (CAPA) plan, or need for additional monitoring is discussed. These results are used to substantiate any recommendations for quality improvement.

Program

Assessment: Since the inception of our quality assurance program, there has been a significant improvement in study management and regulatory compliance. The year’s quality monitoring activities are summarized in a research quality dashboard, which includes performance metrics on critical quality parameters. Dashboard metrics assess compliance and measure progress against established goals in the following areas:
• Obtaining informed consent,
• Confirming subject eligibility,
• Maintaining confidentiality and privacy,
• Research billing compliance and
• Study implementation timeframes
In conjunction with quality monitoring results, these qualitative and quantitative measures of compliance and quality reveal critical actionable insights, helps inform research education for teammates and sets and maintains standards for quality and integrity.
The quality team has seen consistent positive trends in quality reviews that are determined to be acceptable, in which there were zero or only minor deficiencies or noncompliance identified and corrected during the review. We have achieved 100% compliance in obtaining informed consent and subjects meeting eligibility criteria to participate in a trial. Our institution has also advanced from research billing being flagged as a “high risk to billing compliance” to “no findings” on the 2022 Internal System Billing Audit.

Limitations: Currently there is only one reviewer to assess quality regulatory across our Research Institute, which only allows for approximately 2% of all clinical trials to be fully evaluated (e.g., IRB and regulatory file, subject charts, investigational product/device accountability). Focus reviews, those in which a specific process is evaluated, allows for evaluation of multiple studies to identify emerging quality issues; however, many are conducted remotely which is limits the information available to review.

Discussion: Quality assurance programs can be integrated into existing infrastructure at other institutions with stakeholder support. Institutions and organizations that participate in clinical trials assume a level of risk that a developed quality program can help manage and mitigate. In creating a quality program, institutions should consider areas such as education, training, experience, as well as policies and standard operating procedures (SOP) that guide and govern the quality monitoring activities. Consideration should be given to developing a program SOP, templates, monitoring tools, and institutions should determine the scope of quality monitoring reviews of their studies to implement the program successfully.