7:00 am Registration and Morning Coffee
8:00 Welcome & Chairperson’s Opening Remarks
8:15 More than Monitoring: The Changing Expectations of the Monitor’s Responsibilities
Darren Cowan-Bittner, Regional Team Leader, Clinical Research, Western Canada, Pfizer Canada, Inc.
Kathleen M. Recchiuti, Clinical Study Standards Lead, U.S. Clinical Operations, Clinical Study Operations, PGRD, Pfizer, Inc.
The main function of a clinical research associate is to monitor clinical trials to ensure subject protection, protocol and ICH compliance, and data integrity. This main function remains the priority, but it is also clear that expanding the role to incorporate a management skill set to assess, explore, and develop sites, relationships, and expectations is necessary to meet the needs of the business behind the science. Cost, speed, and quality drive business, and current trends in monitoring models integrate skill sets to support this demanding environment. This presentation will focus on identification of an updated skill set required to excel in today’s clinical trial monitoring environment. The speakers will share an overview of Pfizer’s monitoring group trends.
8:55 The Risk-Based Monitoring Plan
John Creech, CCRP, Clinical Research Associate, Clinical Operations, Abbott Vascular
There is often a tendency to over-emphasize routine monitoring processes rather than identifying the most appropriate means of addressing the underlying concerns. A risk-based monitoring program focuses a sponsor’s resources on areas of highest potential risk that contribute to the success of the study, mainly protection of subjects’ safety and rights and integrity of study data. A pre-enrollment risk analysis results in a monitoring plan that includes an ongoing quality assurance program. To remain competitive, sponsors need to adopt risk-based monitoring plans to better allocate resources, better prepare themselves for audits, and increase their chances for successful clinical trials. In this presentation, we will review the creation, implementation, and results of a successful risk-based monitoring plan.
9:35 Preparation for an FDA Audit
Michelle Noe, Senior Regulatory Operations Officer, Office of Regulatory Affairs, New England District, U.S. Food and Drug Administration
Patricia Murphy, Bioresearch Monitoring Specialist, Investigations Branch, U.S. Food and Drug Administration
This session will provide a key regulatory point of view. This presentation will focus on what to expect during an FDA inspection, and will include a discussion of federal regulations covering clinical research, clinical investigator obligations, specific problems seen during inspections, and various methods used to ensure compliance. Identification of problems to avoid and various methods to ensure compliance with regulations and study protocol will also be addressed.
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10:15 Networking Coffee Break and Exhibit Viewing
10:45 What the FDA Warning Letters Tell Us About Clinical Monitoring: Diverse Perspectives on a Critical Process
Barbara van der Schalie, Contractor, Clinical Training Manager, Clinical Research Monitoring Program, SAIC-Frederick
This presentation will include a review of trends in recent FDA Warning Letters, both from a process perspective and from an individual responsibility perspective. The clearest guidance provided by the FDA is contained in the FDA Warning Letters. A review of these letters will provide an overview of compliance hot spots as well as emerging areas of interest. The audience will gain a blueprint for building and maintaining a compliant, effective clinical monitoring system, including process and personnel.
11:25 Monitoring in an Era of Change
Barbara E. Tardiff, M.D., MBA, Corporate Vice President, Clinical Research Services, PAREXEL International
The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership of the FDA’s Office of Critical Path Programs and Duke University, established in November 2007. Stakeholders include over 50 organizations including government agencies, industry representatives, patient and consumer representatives, professional societies, investigator groups, academic institutions, and other interested parties. The mission of CTTI is, “To identify practices that through broad adoption will increase the quality and efficiency of clinical trials.” One of CTTI’s projects is an assessment of monitoring activities. The objectives are to review current monitoring practices and rationale, define quality objectives, and provide qualitative assessment of monitoring techniques. Dr. Barbara Tardiff, a thought leader in the conduct of clinical research and a member of the CTTI Steering Committee, will present: current thinking on the intent and goals of monitoring; practices that are currently employed to meet; monitoring objectives; an assessment of how well current methods enable us to achieve objectives; and changes in monitoring methods being considered to improve our ability to meet intent and goals.
12:05 pm Sponsored Luncheon (Opportunity Available, Contact Arnie Wolfson: 781-972-5431, awolfson@healthtech.com ) or Lunch on Your Own
1:20 What One Site Learned from Their First FDA Audit: Sharing and Learning from the Experience!
Nada Mlinarevich, Research Manager, Department of Neurosurgery, University of Illinois, Chicago
This session will provide a first-hand account from an academic site that experienced an FDA audit. The presentation will be all-inclusive, ranging from the initial call from the FDA requesting the audit, to the follow-up communications post-audit, to the issuance of FDA Form 483. This session will provide helpful tools which can only be gained from the real-life experience of an FDA audit. The audience will receive tips on how to prepare for an FDA audit, what to do during the process, how to delegate tasks, and how to ensure proper follow-up with the FDA and other key participants, including the IRB.
2:00 Monitoring “Worst Practices”: The Impact of Bad Habits and Corner Cutting
Christine Sahagian, M.S., Associate Director, Clinical Compliance, Biogen Idec
A monitor’s work is never done... or so it seems. Between source data verification, query resolution, investigational product management, regulatory document review, trip reports, follow-up letters, and other important site management activities, it is sometimes tempting to take shortcuts or skip a few of the details. This presentation will review, through presentation of actual examples and case studies, the possible consequences and impact of these “bad habits.”
2:40 Working with Clinical Sites to Implement Corrective Action Plans that Work!
BJ Guthrie, Manager, Clinical Operations, Clinical Research, Abbott Vascular
This is a session focused on how monitors can work effectively with clinical sites to develop and implement appropriate corrective action plans in order to address non-compliance. This discussion will also include how and when to evaluate the effectiveness of the corrective action plan. Our organization has effectively implemented the use of the site Corrective Action Plan (CAP) in order to maintain compliance at our clinical research sites. The audience will gain an understanding of when sites need to develop a CAP; how to work with sites to implement a CAP; and how to evaluate the effectiveness of their corrective measures.
3:20 Networking Refreshment Break and Exhibit Viewing
3:40 A Discussion of Best Practices in Site Budget and Contract Negotiations for 2010: Getting to Win-Win
Felicia Favorito, RN, MS, Senior Manager, Clinical Operations, Millennium: The Takeda Oncology Company
There are a variety of issues that may come up in the budgeting and contracting process that may cause obstacles and delay the Site Initiation Visit. This session will concentrate on identification of common pitfalls to avoid and best practices to implement to optimize efficiencies. The focus will be on Site/Sponsor or Site/CRO relationships that are critical to success. In addition, the speaker will touch on factors to consider in building an acceptable budget, including start-up fees, standard of care, insurance reimbursement, and other hot topics.
4:20 The Monitor’s Guide to Effective Site Training
Millie Shultz, Senior Manager, Clinical Operations, Millennium: The Takeda Oncology Company
This talk will provide a background on sponsor and investigator responsibilities as they pertain to investigator selection and clinical trial training. A brief introduction to current training programs for institutions and investigators will be reviewed. The most common deficiencies noted during audits and how to mitigate these with effective training will be discussed. The speaker will discuss how to effectively train an investigative site team to ensure understanding of the protocol across all team members. The value of emphasizing the science behind the molecule and protocol as a means of increasing patient safety will be reviewed. Implementing ongoing training during the course of a study will also be addressed.
5:00 It’s Not About the M&M’s: Measuring Quality in Clinical Research Activities
Maggie Ayers, B.Sc., Director, Clinical Studies, Astellas Pharma Global Development, Inc.
Investigators, study coordinators, and monitors are essential in the conduct of a successful quality-driven study. After the database is locked and sites closed, Study Managers provide a statement in the clinical study report summarizing study quality activities which support study outcomes, including overall data integrity and GCP compliance. If a Clinical Quality Plan is developed in conjunction with the Study Monitoring Plan, pre-defined quality targets, criteria, and standards can be used to manage and assess overall study quality. The focus of the Quality Plan is on source data verification and GCP compliance requirements, with proactive definition of measures for investigator site management and clean, consistent data. This session will incorporate a didactic presentation with facilitated group discussion and an interactive case study simulation to identify the advantages of defining quality targets in clinical research activities. In addition, the challenges of interpreting measured outcomes will be reviewed, with open discussion relative to formulating strategies to meet the challenges of how best to incorporate quality into daily clinical research activities.
5:45-6:45 Reception and Exhibit Viewing (Opportunities Available, Contact Arnie Wolfson: 781-972-5431, awolfson@healthtech.com )