Risk-Based Monitoring of Clinical Trials: Say Goodbye to 100 Percent Source Document Verify
Overview:
The presentation reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data.
This presentation will also review the information provided in the 'Compliance Program Guidance Manual' for BIMO inspectors 'CHAPTER 48 - Bioresearch Monitoring' for foods, biologics, drugs and devices (CPGM 7348.810 for sponsors, CROs and monitors and CPGM 7348.811 for clinical investigators and sponsor-investigators), as implemented in March, 2011. These documents are designed to clearly articulate alternative practices for a "modern, risk-based approach" to monitoring, and attendees of this audio conference gain valuable insight on the changes, and the resulting opportunity to change the way monitoring is done in efforts to improve attention to human subject protection, high quality data and cost containment.
Why should you attend:
LEARN WHAT TO CHANGE! This presentation reviews three FDA recent guidance documents about monitoring and discusses the changes needed in the industry to improve quality and manage costs.
Areas Covered in the Session:
- Three FDA documents will be reviewed about risk-based monitoring, including a draft guidance for sponsors and two guidance documents for BIMO inspectors as they oversee the conduct of clinical studies
- Key 'risk-based' approaches to monitoring
- How to develop a monitoring plan, from the perspective of the inspector, sponsor, monitor, or coordinator
Who Will Benefit:
- Directors of Clinical Affairs
- VPs & Directors of Regulatory Affairs
- Manager of Quality Affairs
- Clinical Research Coordinators & Associates
- Research Nurses, Scientists and Others
- Clinical Project Managers