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Barnett International and Cambridge Healthtech Institute’s Third Annual Clinical Training Forum will feature case studies, lessons learned and presentations focused on the challenges associated with role-based training in the clinical research environment. Included are strategies for linking training initiatives to study outcomes, key regulatory considerations and findings, and examples of how training deficiencies can put clinical research activities at risk. Leading industry training professionals will share their approaches to managing training challenges, as well as how they leverage resources across their companies to optimize training and compliance.
WEDNESDAY, OCTOBER 5, 2011
7:30 am Morning Coffee
8:00 Training Personnel for Optimal Performance and Reliable Study Data
Cheryl Vitow, President, Medical Writing and Clinical Management Consulting, CliniQuill Associates, LLC
Any successful clinical trial relies upon the efforts of all parts of the clinical team. In this session, we will discuss key techniques for training these personnel, the idea of training as a continual process, tools for effective communication, ways to exact self-sufficiency, and methods for determining when the process is working. This talk will explore the intricacies of managing the training pieces of a study from the perspective of all of the players. Improved communication between the players coupled with good training tools/materials creates a win-win for all involved. Attendees will be better able to understand how the continuing process approach is critical to the performance of the team, and that optimal performance generates good and reliable study data – and reliable data is the ultimate goal.
8:40 Developing a Culture of Learning and Achieving Executive-Level Buy-In for Your Training Programs
Herb Anthony, Associate Director, Medical Organization Training, MedImmune LLC
In the current economic climate it has become increasingly important for Learning Organizations to accept responsibility for changing the culture and to continuously show why they are necessary. This presentation will identify strategies for moving your organization forward by creating a “Culture of Learning.” Your speaker will share strategies for creating ROI for training, and for effectively measuring the return on investment created by training. The course will also give clear methods for creating executive level buy-in, as well as increasing training budgets based on executive level buy-in. The audience will gain knowledge of how to:
• Initiate change through training and communication
• Establish a learning culture and feed it
• Utilize existing system to show ROI
• Influence executive level buy-in using fact-based data
9:20 Developing and Implementing a Clinical Research Education & Training Curriculum: One Institution's Approach
Shari Zeldin, BA, CCRC, Manager, Clinical Research Compliance Office, University of Wisconsin Carbone Cancer Center
This session focuses on one institution's approach to developing and implementing a Clinical Research Education & Training Curriculum for clinical research professionals at all levels. Training and education in clinical research must be thorough, comprehensive, and continually responsive in order to ensure compliance with federal regulations and institutional requirements. This presentation will highlight clinical research curricula that have been developed for all new and continuing clinical research staff. We will begin by discussing the Clinical Research Core Education Curriculum, including the essential elements of clinical research: orientation to terminology, ethical issues, dissecting a protocol, the informed consent process, protocol adherence, and regulatory requirements. In addition, your speaker will present a Clinical Research "Ad Hoc" Education Curriculum which is driven by "lessons learned" in the trenches from her role as a Compliance and Monitoring Manager. Your speaker will also demonstrate that the method of delivery of the curricula can sometimes be as significant as the content itself. The audience will learn how to:
• Establish a core clinical research curriculum
• Recognize deficiencies at your site and proactively address the deficiencies through ad hoc education and training opportunities
• "Deliver the goods" in an effective and enjoyable manner
10:00 Sponsored Presentation (Opportunity Available)
(Please contact Ilana Quigley: iquigley@healthtech.com)
10:15 Networking Coffee Break in the Exhibit Hall
10:40 Techniques for Developing Engaging Web-Based Training Programs
Sheri Jacobsen, Assistant Director, Global Clinical Training and
Joseph Pascual, Manager, Clinical Instructional Design, Global Clinical Training, Abbott Laboratories
In today’s industry, it is critical to disseminate information regarding evolving clinical processes, regulations, and best practices to a large global audience in an effective and efficient manner. Given the pace in which clinical research is striving to get trials completed, it is no longer sufficient to develop instructor-led training courses to meet these needs. New information needs to be provided quickly and incorporated into daily work on a real-time basis. This presentation will demonstrate strategies and practices to identify and implement appropriate eLearning tools and utilize them to design and deliver training efficiently and effectively. The audience will gain an understanding and perspective of the key points needed for designing and developing eLearning solutions for global audiences, including best practices and common mishaps.
11:20 Interactive Breakout Discussion Groups
During this interactive facilitated session, participants will be given the opportunity to participate in discussions on key training issues, including what has worked, what has not, and how to move away from making training initiatives a “box checking” exercise. The following topics will be included:
• Addressing Current Regulatory and Inspection Trends in Your Training Initiatives
• Using Interactive Techniques to Make Training More Meaningful
• Assessing Technology Options for Virtual Meetings
• Maximizing Training Resources in Small to Mid-Sized Companies
• Achieving Success in Employing Social Media in Training Initiatives
• Assessment Initiatives: When and How to Test for Core Competency Mastery
12:00 pm Special Walk-and-Talk Networking Luncheon (Hosted in Exhibit Hall)
1:25 Building Meaningful Training Content for Global Participants
Elana Ehrlich, Learning Manager, Merck Polytechnic Institute: Merck
How can one support consistent, effective learning around the globe? The Merck Polytechnic Institute (MPI) is a training organization that seeks to provide one-stop shopping for all of the educational needs of Merck Research Labs (MRL) using a centralized training model. In an effort to ensure alignment between Headquarters and Global Regional Operations, MPI implemented two key roles that are instrumental in rolling out training for global initiatives. The Learning Managers support centrally managed functional areas while the Clinical Learning Specialists are assigned to and located within a region. This presentation will review the MPI model, discuss how it was deployed to deliver large scale global process training to over 4,000 people in Global Clinical Trial Operations (GCTO) in six regions, and provide a case study.
2:05 Designing Clinical Research Training for Global Teams: Lessons Learned from the Field
Penelope Jester, Program Director, Pediatrics, University of Alabama at Birmingham
With the explosion of clinical research in often research naïve communities around the globe, providing comprehensive and rigorous clinical research training in the management and implementation of clinical studies is imperative. Successful clinical trials employ study coordinators who are responsible and knowledgeable about clinical research planning and implementation. In the past two years a distance based-learning program called Promoting Enhanced Research Capacity (PERC) was created with the support of a Challenge Grant through Fogarty International. This presentation will describe the framework of the distance based learning effort as well as the advantages of such a program. The audience will learn about techniques for distance based learning and capacity building, as well as be provided with guidance on accessing a current, dynamic program.
2:45 Networking Refreshment Break in the Exhibit Hall
3:10 The Role of Regulations in Clinical Trials: A Scenario-Based eLearning Module Case Study
Becky Meiers, Training Consultant, Eli Lilly & Company
Much GCP training tends to focus on the regulations themselves rather than the application of the regulations using critical thinking. This presentation features a case study of Eli Lilly’s “The Role of Regulations in Clinical Trials,” a scenario-based eLearning course that features ICH, FDA, EU, and local regulations. The course is designed to cultivate the critical thinking of sponsor personnel via the application of regulations to realistic clinical trial situations in 10 topic modules, from Preparing for a Clinical Trial, to Conducting a Clinical Trial (from the investigator's perspective), to Preparing a Clinical Study Report. Each of the 10 topic modules has an exam so that learners can demonstrate content mastery and experienced learners can save time if they are able to “test out.”
3:50 Applying Adult Learning Principles In Order to Optimize Training and Compliance
Susan Bosworth-Farrell, BSN, RN, CCRC, CCRP, Senior Field CRA, Abbott Vasular
This session will review adult learning principles and then offer specific examples of how to utilize them to develop more effective training and compliance, and improve retention by the learners. Examples will include incorporating new media into presentations and ideas to facilitate active involvement in training presentations. Theory and examples will be used to illustrate possible impact to learning in both device and drug venues. Methods for evaluating training sessions and assessing the effectiveness will be discussed. The audience will:
• Gain knowledge of what adult learning principles are and how to utilize them for more effective presentations
• Describe at least one way of integrating an adult learning principle into a clinical research presentation
• Describe at least one tool to evaluate learning success
4:30 Practical Classroom Training Tips – Don’t Learn the Hard Way!
Nancy Giard, Global Training Lead, EIT M&C (Enterprise IT Marketing & Communication), Genzyme
As a trainer and former teacher, your speaker has learned many lessons “The Hard Way,” and admits to mistakes made along the way. Unlike most professionals, trainers have the added glory of making most of their workplace mistakes in front of an audience. There’s nothing quite like the feeling when your class completely derails, when a participant challenges you all day, or when you leave your lapel microphone on during the restroom break. Woven with comical commentary drawn from real-life experiences, this presentation will not include a PowerPoint, instead focusing on the speaker’s “One Page of My Best Advice for Trainers.” Your speaker will cover a wide range of topics, including preparing for a training, using credible body language, managing in-training conflict, and developing professionally as a trainer.
Wednesday, October 5, 2011 - 6:15 - 8:15 PM
Instructor: Ruth Dubinsky, President, Clarity Consulting
* Separate registration required.
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