Day 1 | Day 2
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.
Monday, June 4, 2012
7:00 am Registration and Morning Coffee
8:00 Welcome & Chairperson’s Opening Remarks
8:15 Risk-Based Monitoring: Abbott Vascular’s Enhanced Monitoring Initiative
Stanley E. Reaves, Jr., RCIS, Senior Clinical Research Associate, Abbott Vascular
John Creech, CCRP, Senior Clinical Research Coordinator, Abbott Vascular
This is a practical session that will provide insight into how Abbott Vascular has implemented a risk-based monitoring approach in the clinical organization. This session will describe how using this risk-based, enhanced monitoring approach has helped to increase efficiencies and produce cost savings while maintaining a high level of quality and compliance in clinical trials. This session also will describe background information and current industry trends, the processes and tools used to implement enhanced monitoring at Abbott Vascular, as well as the challenges and perceived benefits of using this approach.
9:00 A Risk-Based Approach to Monitoring: A Sponsor’s Perspective
Linda Tedder, Senior Clinical Project Manager, DePuy Franchise Clinical Operations
A sponsor is responsible for ensuring adequate monitoring per the regulations, and FDA has issued a new guidance document specifically addressing this topic. There are a variety of ways to approach monitoring to ensure that you get the best data, all the while ensuring the quality of the data. Monitoring can be done onsite or offsite, or a combination of both. A sponsor needs to determine what works best for a particular study, and then draft the monitoring plan to ensure that quality is achieved.
9:45 Coffee Break
10:15 Lessons Learned through a Challenging Site FDA Audit: A Case Study
Nancy Bakke, Principal Clinical Study Manager, Clinical Research Monitor, Sorin CRM USA, Inc.
Even though there are no federal regulations against the sponsor completing CRFs, the FDA Inspector’s claws came out during this recent FDA Audit. The inspection became about this issue, and nothing else. The practice of sponsor personnel completing case report forms is not the norm; however, there are many other practices that are not against regulations that the Inspector may focus on. In this session, your speaker will provide insight into how to prepare your site for the FDA audit; how to quickly turn the Inspector’s focus to where it should be; and how to respond to the 483.
» INTERACTIVE ROUNDTABLE DISCUSSIONS
11:00 Facilitated Breakout Sessions (choose one)
A. Approaches to Site Training: Implementing, Following-Up, Documenting, and Evaluating the Effectiveness of Training Initiatives
B. Monitoring in the Electronic Environment: EMRs, eCRFs, and Tablet-Based EDC
C. Meeting Global Monitoring Challenges: Global vs. US Regulations, Country- and Region-Specific Monitoring, and Achieving Cultural Competency
D. Hiring, Training, and Retaining Monitors
E. Site Budgets and Contract Negotiations: Best Practices, Pitfalls, and Optimizing Efficiencies
11:45 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
Join your colleagues at the Clinical Quality Risk Management track for these joint sessions. Click here for full session abstracts.
1:00 pm FDA Draft Guidance on Risk-Based Monitoring of Clinical Trials
Anne Marie Murphy, Principal, Hyman, Phelps & McNamara
1:45 Clinical Site Issue Escalation: A Vital Process in Clinical Quality Management
Daniel J. Greenwood, Senior Associate Director, Compliance & Quality Management, Boehringer Ingelheim Pharmaceuticals, Inc.
2:30 Transitioning from Auditing to a Quality Improvement System
Johanna L. Stamates, RN, MA, CCRC, CHRC, Executive Director, Regulatory Support and Quality Assurance, University of Miami
3:15 Sponsored Presentation (Opportunity Available)
3:30 Refreshment Break
3:50 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
80% of clinical trials are not enrolled on time. This delays time to market and increases clinical trials costs. The use of targeted strategies to identify and select the right sites for your trial increases the efficiency and decreases the costs of your trials. The pre-study visit and the CRA are essential in this model. In this session, participants will learn how to:
- Craft and administer an effective site assessment form to preliminarily identify the right centers
- Use the pre-study visit to ensure you have the right sites
- Train your CRAs to be the best at site identification
4:35 Monitoring 2.0: Root Cause Analysis and CAPA Planning at Investigative Sites
Karen L. Gilbert, BS, CCRA, Clinical Trainer & Curriculum Manager, Barnett International
A successfully conducted clinical trial requires comprehensive management of non-compliance by all stakeholders, leading to improved human subject protections and confidence in the integrity of the data. The critical role of the CRA/Monitor in this endeavor is increasingly being recognized, even to the point of its inclusion in the FDA’s August 2011 Draft Guidance entitled “Oversight of Clinical Investigations – A Risk Based Approach to Monitoring.” This presentation will present strategies to aid clinical research monitors in accomplishing the following:
- Identify and recognize non-compliance
- Understand the root cause
- Facilitate the selection of interventions to correct and prevent recurrence (where applicable)
- Evaluate the effectiveness of the intervention
5:20 Tools, Tricks, Tips, and Apps: Making Monitoring Easier
Sarah Ramey, Clinical Research Associate, Clinical Operations, Duke Clinical Research Institute
In this practical session, we will discuss how to leverage your phone and computer programs in many aspects of monitoring and travel. Have you ever been onsite with internet service down, and you need to know what a mystery conmed does? There’s an app for that! You can program an Excel spreadsheet to automatically tell you which subjects are out of window, who needs to sign which consent, and which ones you have monitored. Using these tools and more not only make monitoring easier, they also facilitate critical thinking so you can be a better monitor. Please bring your smartphone or tablet to learn hands-on and to share your own tools, tricks, tips, and apps!
6:05 Welcome Reception (Sponsorship Opportunity Available)
7:00 Close of Day One
Day 1 | Day 2