Quality Assurance at the (Clinical Research) Site: How to Develop a Manageable Plan

Why Should You Attend:

Is your site carrying out clinical research in accordance with regulatory expectations? You have training requirements for investigators and coordinators, is that enough? Is it worthwhile training that covers necessary topics? A Quality Assurance (QA) Program is the vehicle to help you answer these questions and more.

Quality assurance is often confused with monitoring or auditing. Understanding the principles of quality assurance and how QA differs from monitoring and auditing is critical to establishing a program that enhances compliance without creating unnecessary redundancy.

This webinar will show how one can develop a mechanism for providing feedback from QA to enhance education and training of their investigators and coordinators. If you belong to a site, or work with a site, that relies on external sources - monitoring visits, IRB review, FDA audit, etc. - for evaluation and feedback, then your site will benefit from this training.

In this 90-minute session, attendees will learn fundamental concepts and strategies to get their site started with a QA program that verifies clinical research practices as they are operationalized at the local site.

Learning Objectives:

At the end of this program attendees will be able to:

• Describe the purpose of a Site Quality Assurance Program.
• Differentiate a QA program, monitoring and auditing.
• Utilize resources to evaluate a clinical research program.

Areas Covered in the Webinar:

• Elements of Quality Assurance Program.
• Elements of Monitoring.
• Elements of Auditing.
• Roles and responsibilities of study team members.
• Training and Education requirements.
• Implementing change.

Who Will Benefit:

This webinar will provide valuable assistance to following personnel:

• Experienced Clinical Research Coordinators
• Experienced Principal Investigators
• Experienced Clinical Research Associates (Monitors)
• Site Based Clinical Research Managers and Administrators
• Regulatory Compliance Associates and Managers

Jennifer Holcomb
Director, Clinical Research Support Office, Duke University

Jennifer Holcomb, MA, CCRC, is a clinical research professional with over 20 years of experience in the field. Currently employed by UCHealth Systems, ([email protected]), she provides guidance and leadership in the establishment and development of policies in the conduct and management of clinical research. Key areas of expertise include clinical trial budgeting and contract negotiations as well as regulatory knowledge including international ICH GCP standards. Jennifer has extensive experience in training and education and complete a 4 year term as Vice Chair of the ACRP Professional Development Committee.

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