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Quality Assurance at the (Clinical Research) Site: How to Develop a Manageable Plan
This 90-minute webinar will show how you can develop and implement a Quality Assurance (QA) program at your clinical research site that ensures the staff are properly trained and that the research is carried out in accordance with regulatory expectations.
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 you can develop a mechanism for providing feedback from QA to enhance education and training of your 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, you will learn fundamental concepts and strategies to get your site started with a QA program that verifies clinical research practices as they are operationalized at the local site.
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 Seminar:
- 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 all personnel in:
- 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, MA, CCRC, is a clinical research professional with 20 years of experience in the field. Currently employed by Duke University, 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 serves as Vice Chair of the ACRP Professional Development Committee.
ComplianceOnline would process/provide refund only if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs."
For substitution, please email firstname.lastname@example.org or call +1-650-620-3937.
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