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Friday, October 12, 2012
8:00 Morning Coffee
8:30am Chairperson’s Welcome
8:45 Data Safety Monitoring Board (DSMB) Training: The What? Why? and How?
Barbara van der Schalie, Clinical Training Manager, Learning and Professional Development, Clinical Research Directorate/CMRP, SAIC-Frederick, Inc., Frederick National Laboratory for Clinical Research, (Funded by NCI Contract No. HHSN261200800001E)
Although Data Safety Monitoring Boards (DSMB) provide sponsors with critical quality oversight to clinical trial data, there are few, if any, curricula or training materials available to aid in the orientation of new DSMB members, or to broaden the pool of qualified participants. This session will outline the National Institute of Allergy and Infectious Diseases (NIAID) process in identifying training requirements for this critical function as well as sharing the three DSMB training modules developed for web-based access, which are free of charge to the public. The modules include: an introduction to the objectives and purpose of DSMBs, the organization and responsibilities of DSMBs and statistical topics.
9:30 Strategies for Efficient Teaching and Training in Resource-Poor Settings
Gabriele Pohlig, Ph.D., Head, Quality Management Services, Department of Medicines Research, Swiss Tropical and Public Health Institute
More and more clinical trials are conducted in emerging economies reaching out into very resource-poor settings. Working in these environments poses not only particular social and ethical challenges but often confronts trial organizers with very limited capacities and experience of site personnel. How to translate the high regulatory and technical requirements of today’s clinical trials into resource-poor settings which have so far been untouched by research activities asks for sensitive and well structured training concepts that take cultural differences in teaching and learning into consideration. This presentation will highlight the many-fold challenges encountered by trainers in these particular environments and provides solutions and concepts to meet them.
10:15 Coffee Break with Exhibit Viewing
10:45 Sponsored Presentation (Opportunity Available; contact Ilana Quigley firstname.lastname@example.org)
11:00 Clinical Research Training for Global Teams
Cathy Ollom, RN, BSN, OCN Global Training and Education, Sarah Cannon Research Institute
Maribeth Johnson, CCRP Research Educator, Sarah Cannon Research Institute
Quality training modules are in much needed demand throughout all clinical research settings and locations. Reinventing the wheel consumes time and resources, therefore strategizing means to fulfill various training needs by making simple modifications. In this presentation, we will discuss the value of streamlined training programs that can be adapted to fit the need of various global research environments. We will discuss the variety of training delivery vehicles (webinar, webcast, recordings, etc.) available, including advantages and disadvantages of each.
11:45 Successful Implementation of New Learning Management System to 60,000 Remotely Based Global Site Personnel
Deborah Piquette, Learning Manager, Merck Polytechnic Institute, Merck & Co., Inc.
In April 2012, Merck launched a new Learning Management System (LMS) to facilitate delivery of non-protocol specific training to global site personnel participating in Merck clinical trials. The new external LMS consolidated site users from two legacy training systems previously used by two large pharmaceutical companies prior to a merger. This presentation describes the change management, technical and logistical challenges of this deployment, not least of which was a lack of direct access to the target audience.
12:30pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
» Hands-On Session!
1:45 Incorporating Elements of Play into Training:
A Hands-On Session
Karen L. Gilbert, BS, CCRA, Clinical Trainer & Curriculum Manager, Barnett Educational Services
The world of clinical research is a serious business with both the health of research volunteers and the business success of our employers on the line. However, all work and no play not only makes Jack a dull boy; it also can make training feel like just one more thing on your participants’ long to-do list. Join us at this session as we explore ways to incorporate a sense of play and discovery into GCP and role-specific training programs.
This presentation requires participants to bring their playful spirit and curiosity as we embark on a “play date” with several relatively easy-to-implement, low-cost, yet effective games and activities for clinical research trainers.
2:30 Guide for Developing a Successful, Cost-Effective, Site Based Clinical Research Training Program
Lynette Westbrook, RN, MS, CCRC, Research Nurse Specialist, Cardiology Stem Cell, University of Texas Medical School and Texas Heart Institute
Training clinical research coordinators can be expensive, in both time and financial resources. As such, developing a site-based curriculum that is maintainable, cost-effective, and successful can meet those needs. Hear about the strategies that have emerged throughout the history of Texas Heart Institute’s clinical research training program. The development and successful use of a coordinator training advisory board in developing the curriculum and course implementation will be shared. Also covered are the changing educational needs of the personnel who conduct clinical research and the adaptation required to meet those needs. Finally, the frequent training follow-up included as part of the program is discussed.
3:15 Refreshment Break
3:30 Understanding the Importance of Training in Minimizing Clinical Research Risk
Sydney Douglas M.S., Corporate Training, Training, Copernicus Group IRB
Training initiatives play a significant role in the clinical research process and best practices are imperative. A better educated staff leads to more competent employees, increased company loyalty and improved client communication. In this presentation, hear how training has become a key factor toward minimizing clinical research risk, particularly from an IRB perspective. Specifically three ways to ensure training best practices within your IRB are covered, and resources for achieving important training information are provided.
4:15 Implementing Effective Social Media Initiatives into Your Training Strategy
Nancy Giard, North America IS Marketing, Communications & Training, Sanofi
5:00 Close of Conference
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