QA/QI: Human Subjects Research

Learn about QA/QI programs, how to conduct an internal audit, and strategies for using the findings.

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About this Course

QA/QI programs are integral to the protection of the rights, safety, and welfare of human research subjects. This course provides foundational training on establishing or refreshing your own QA/QI program and using internal audits to improve quality in research conduct and compliance.

Internal audit programs may include different types of audits such as not-for-cause (often referred to as routine audits) and for-cause as well as other quality activities such as preparatory reviews and self-assessments. Audit findings provide valuable insights to support individual investigators, organizational compliance, and QI efforts. More specifically, audits can uncover potential issues in the conduct of research, reveal education and training needs, and provide a clearer picture of research compliance for organizational leadership.

The four modules in this course are meant to be taken sequentially. The course begins with an overview of QA/QI programs and functions. Then, the second module explores key steps and considerations for establishing or refreshing your own internal audit program (such as using a risk-based framework, assessing available resources, and gaining organizational support). The third module discusses the process for conducting internal audits, including common audit methods and factors to consider throughout the audit process. The final module provides guidance for using audit findings for improvement with an emphasis on communication, education, and quality systems.

Course Preview:

Language Availability: English

Suggested Audiences: Administrators, Individuals responsible for research oversight and compliance, Institutional/Signatory Officials, Investigators, Research Staff

Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations
Independent Learner Price: $99 per person

Demo Instructions

Course Content

Overview of a Quality Assurance/Quality Improvement (QA/QI) Program

This first module provides an overview of quality assurance (QA)/quality improvement (QI) programs, which are integral to the protection of the rights, safety, and welfare of human research subjects. It describes the components of a quality management system, distinguishes auditing and monitoring activities, and considers the strengths of different QA/QI program structures.

Recommended Use: Required
ID (Language): 20694 (English)
Author(s): Alyssa Gateman, MPH, CCRP - Yale University

Developing an Internal Audit Program

Discusses key steps and considerations for establishing or refreshing an internal audit program, common types of audits, and the importance of metrics and tracking. It considers how a risk-based approach can be used to focus on areas identified as the highest risk, and identifies factors that may affect risk level. It presents the importance of establishing program aims and scope, assessing an organization’s existing resources and dedicated contributions to the QA/QI program, and how those factors impact audit planning activities and implementation.

Recommended Use: Required
ID (Language): 20695 (English)
Author(s): Alyssa Gateman, MPH, CCRP - Yale University

Process for Conducting Internal Audits

Presents a general overview of the internal post-approval audit process conducted by human subjects research QA/QI programs. It describes common audit methods and tools, although the specific implementation and operationalization of the process may vary among organizations. It identifies commonly used methods, tools, and templates for internal audits.

Recommended Use: Required
ID (Language): 20696 (English)
Author(s): Sana Khoury-Shakour, PhD, CCRP - University of Michigan

Lessons Learned: Using Audit Findings for Improvement

Describes how QA/QI programs translate findings from post-approval audits into systemic changes to improve the quality of research. It outlines communication strategies and provides examples of educational approaches and tools that QA/QI programs may implement to drive QI initiatives.

Recommended Use: Required
ID (Language): 20697 (English)
Author(s): Sana Khoury-Shakour, PhD, CCRP - University of Michigan


Who should take the QA/QI: Human Subjects Research course?

The QA/QI: Human Subjects Research course is for those individuals directly involved in quality assurance in human research, including those who oversee, coordinate or conduct internal audits and inspections of researchers, research studies, and sites. This audience includes compliance professionals, auditors, and Human Research Protection Program (HRPP) administrators and professionals. It is both for those new and experienced with QA/QI, and for programs big and small.

What are the benefits of this course?

Learners in this course will gain a deeper understanding of quality assurance programs and their roles and responsibilities in human subjects research. This course provides an in-depth training on QA/QI programs with focused modules covering the basics of what a QA/QI program is, how different models function, what an internal audit covers and how to conduct it, and how to communicate and use audit findings to guide educational and training.

How long will the course take to complete?

The QA/QI: Human Subjects Research course consists of four modules. Completion of all modules, as well as the corresponding quizzes should take approximately 2 hours.

Is this course eligible for continuing medical education credits?

This course does not currently have CE/CME credits available.

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