Conference & Events
Maintaining Compliance of Clinical Sites with Regards to the FDA Draft Guidance on (Risk-Based Approach to Monitoring)
Overview: Monitoring of clinical sites is a critical part of the Good Clinical Practices. With the advent of electronic data capture (EDC processes and more recently the FDA guidance, Oversight of Clinical Investigations-a Risk-based Approach to Monitoring some changes in the way we monitor sites and the data collection are taking place.
Date: 18 July 2012 10:00 - 11:00
1000 N West Street
DE | USA | 19801
United States of America
Contact for Event Information
Name : Webinars
1000 N West Street | Suite 1200
United States of America
Dr. McLane has over 25 years of progressive experience in all phases of global development with both large and small pharmaceutical companies. His knowledge basis has lead full development projects with over 50 clinical and medical device programs and to successful INDs, IDEs, NDAs and EMEA/CTA applications. Key strengths include the early development of clinical and regulatory strategies, risk management and identification, and negotiating with regulatory officials.
Why you should attend: The FDA is removing the old guidance document on monitoring and recommending changes that conflict with conventional Good Clinical Practices (GCP) that have been in place since the ICHE6 guidelines had been issued. What that means is more of the clinical team needs to be involved with monitoring the sites and the sites need to document compliance by additional means beyond source documentation.
The routine monitoring of the sites would now goes beyond the CRA going to the site but also involves Project Managers, data management, statistics, medical monitoring, pharmacovigilance, and lab and IMP management. Sites need to know how the monitoring will change when and what they have to do (and when) to demonstrate compliance with the protocol, safety evaluations and assessments, data entry, and laboratory collection and assessments. Site-specific and study-specific documents such as Study Operations Manuals and monitoring plans should be changed to address the changes in monitoring. Project managers need metrics to assess when risk-based monitoring provides signals that could indicate changes in oversight may be needed to maintain data integrity and patient safety.
Areas Covered in the Session:
Summary of guidance document: Oversight of Clinical Investigations-a Risk-based Approach to Monitoring
Preplanning for high risk monitoring
Roles of different clinical team members (e.g. project manager, clinical research associates, data management, biostatistics, clinical site coordinator, principle investigators, clinical trial associate)
Documentation (e.g. process and process maps, monitoring plans, monitoring reports, issue escalation)
Who Will Benefit:
Site Clinical Coordinators
Clinical Research Associates
Clinical Trial Associates