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.
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