Integrity & Quality

We help our researchers maintain the high ethical, quality and integrity standards of their research. We monitor research programs and clinical trials and share our observations with the researchers to improve practices and processes.

Overview

Integrity, Quality & Service: The Aurora Advantage

At Aurora Health Care, our high-quality, ethical research allows us to discover better treatments and improve health outcomes for our patients.

The Integrity and Quality team acts as a fresh pair of eyes looking over research programs and clinical trials. Our observations and suggestions help researchers maintain high standards and preserve Aurora’s exceptional reputation.

We look at:

  • Regulatory compliance: We review all study documents for compliance with regulations governing research and clinical trials. These regulations include safeguards for research participants and protections of their privacy.
  • Informed consent: Our team reviews consent documentation. We make sure research participants are fully informed about the risks and potential benefits of the trial or project.
  • Accountability: We verify that test articles – the drugs or devices the research is investigating – are handled and controlled in accordance with federal regulations or the research proposal’s protocols. These rules help achieve participants’ safety and maintain the integrity of the research.
  • Documentation: Our researchers keep detailed and accurate records of all aspects of their research. These records verify the integrity of data and validate outcomes.
  • Billing: Many participants in clinical trials do not pay for the drugs or devices being tested. We make sure services are billed correctly.

Monitoring

Monitoring Quality & Integrity Across Aurora

Aurora researchers and patients participate in and conduct hundreds of clinical trials and research projects.

To maintain consistent high standards across Aurora, the Integrity and Quality team monitors a representative cross-section of programs each year. We identify areas of strength and areas where we could improve.

We present our reviews to the Council for Quality Assurance and Improvement in Research (CQAIR). This advisory board considers our results and recommends education initiatives or other solutions as needed.

CQAIR is responsible for maintaining research quality standards and preparedness for review and inspection at Aurora. The board looks at a wide range of elements, including:

  • Policies and procedures
  • Data integrity
  • Compliance
  • Risk-based monitoring
  • Training and education
  • Continuous improvement

Proactive Monitoring

Supporting Research Improvement

As a proactive measure, we identify high-risk projects and monitor them closely. We look for patterns or trends to identify areas that need improvement or additional training.

The Institutional Review Board (IRB) has identified several factors that may benefit from closer monitoring. CQAIR takes these factors into consideration when recommending which projects the Integrity and Quality team monitors:

  • New investigators or research staff
  • Novel drugs or devices
  • Complex studies or trials
  • Vulnerable subjects
  • Funding source
  • History of similar research projects

The IRB approves all research and clinical trials at Aurora involving human subjects. This committee determines whether a research proposal meets stringent ethics standards and verifies that a project has structures in place to protect the participants. Learn more about IRB.

Solutions 

Advice & Corrective Action

We are a resource for researchers. By providing detailed reviews of research and suggesting improvements, we help researchers maintain the quality and integrity of their work.

Support tools we provide:

  • Quality performance metrics: We have developed metrics, like enrollment and implementation measurements, to assess quality performance. These metrics allow us to demonstrate performance trends and identify risks.
  • Corrective and prevention action (CAPA): When we identify an ongoing problem, we ask the principal investigators or department leaders to devise a CAPA plan. The investigators analyze the root cause of the problem and correct it immediately. Then they establish an action plan to prevent the issue from happening again.
  • Education: Aurora’s research educator is a member of CQAIR and incorporates our recommendations into education initiatives.

Learn more about Aurora’s researcher resources.

How to Participate

Find out more about ways to participate in research.

Collaborate With Aurora

Bring our expertise and data to your research program.

Work for Aurora

Learn more about our employment opportunities.

Clinical Trial Enrollment

Learn more about our current clinical trials and if you’re eligible to enroll.