The Third Annual Mastering Clinical Trial Monitoring conference will focus exclusively on the changing role and expanding expectations of the experienced clinical trial monitor. Building on the overwhelming success of previous events, thought leaders will share their experiences related to implementing risk-based monitoring plans, enhancing the monitor’s job performance with hands-on techniques and tips, and improving site performance and data integrity. Themes throughout the conference will be building risk-based monitoring plans, monitoring global clinical studies, incorporating the latest regulatory requirements and expectations into your monitoring activities, and meeting the challenges of monitoring in an electronic environment. Attendees can expect sessions that feature case studies, hands-on activities, take-away tools, and interactivity.
Proposals are still being accepted! If you are interested in being a speaker at the Mastering Clinical Trial Monitoring Conference, submit your abstract online or contact:
Rachel Meyers
Associate Director, Barnett International
a division of Cambridge Healthtech Institute (CHI)
T: (+1) 413.527.3056
E: rmeyers@barnettinternational.com
Preliminary Agenda
One Sponsor’s Journey to “Risk-Based” Monitoring: The Abbott Vascular Enhanced Monitoring Initiative
Stanley E. Reaves, Jr., RCIS, Senior Clinical Research Associate, Abbott Vascular
A Risk-Based Approach to Monitoring: A Sponsor’s Perspective
Linda Tedder, Clinical Research Manager, Clinical Affairs, DePuy Spine, Inc.
Understanding the Key Elements and Implications of FDA’s New Risk-Based Monitoring Guidance
Speaker to be Announced
Responding to Recent Updates to FDA’s Compliance Policy Guide Manual (CPGM) for Sponsor/Monitor/CRO Inspections
Speaker to be Announced
Tools, Tricks, Tips, and Apps: Making Monitoring Easier
Sarah Ramey, Clinical Research Associate, Clinical Operations, Duke Clinical Research Institute
Transitioning from Auditing to a Quality Improvement System
Johanna L. Stamates, RN, MA, CCRC, Director, Office of Research Compliance Assessment, University of Miami
Monitoring the Academic Medical Center: Exploring the Challenges and Opportunities of AMCs
Eric Tomasini, Manager, Health Industries Advisory, PricewaterhouseCoopers
Monitoring Investigator-Initiated Trials within a Pediatric Research Institute
Christina McGee, Senior Clinical Research Associate, Office of IND/IDE Support, The Children’s Hospital of Philadelphia
Meeting the Unique Challenges of Medical Device Study Monitoring
Angelia Drake, RN, Surgical Oncology, Baylor Health Care System
Selecting the Right Sites the First Time: How to Use the Pre-Study Visit to Increase Trial ROI
Manley Finch, Executive Director, HIV Nutrition Network, NPO
Site Management through Analytics, Relationships, and Teamwork: Optimizing Relationships for Performance
Ann Dilworth, MPH, Associate Director, Northeast Region, Regional Clinical Operations, US Site Monitoring Group, Bristol-Myers Squibb
Site Relationship Management: Achieving Compliance and Commitment
Millie Shultz, Senior Manager, Clinical Operations, Millennium: The Takeda Oncology Company
Lessons Learned through a Challenging Site FDA Audit: A Case Study
Nancy Bakke, Principal Clinical Study Manager, Clinical Research Monitor, Sorin CRM USA, Inc.
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Abstracts Are Still Being Accepted in These and Other Topic Areas:
- Understanding the Key Elements and Implications of FDA’s New Risk-Based Monitoring Guidance
- Responding to Recent Updates The FDA’s Compliance Policy Guide Manual (CPGM) for Sponsor/Monitor/CRO Inspections
- Identifying, Managing, and Turning Around “Difficult” Sites
- The Monitor’s Role in Meeting FDA Expectations Regarding Good Clinical Practice Quality Systems
- Monitoring in the Electronic Environment: Electronic Data Capture (EDC) and Electronic Medical Records (EMRs)
- FDA Audits and Inspection Trends: Expectations, Preparation, Documentation, Delegation, and Follow-Up
- Careers in Monitoring: Hiring, Training, Retaining, and Promoting Monitors to Management
- Meeting Cultural Challenges and Achieving Cultural Competency in Global Clinical Trials
- Meeting the Unique Challenges of Medical Device Study Monitoring
- Clinical Research Organization (CRO) Monitors: Monitoring Multiple Projects in Varied Environments
- Root Cause Analysis and Corrective Action Planning for Monitors