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Barnett International and Cambridge Healthtech Institute’s fourth 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.
Don’t Miss the Pre-Conference Dinner Short Course*:
Design Considerations for GCP Training Programs
Wednesday, October 10, 2012 (5:30 pm -830 pm)
Instructor: Karen L. Gilbert, B.S., C.C.R.A., Clinical Trainer and Curriculum Manager,
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*Separate registration is required
Thursday, October 11, 2012
7:30 am Breakfast Presentation - Models for Managing Global Clinical Trials: Challenges, Opportunities, and Regulatory considerations.
Cellia K. Habita, M.D., Ph.D., President and CEO, Arianne Corporation
The past few years have witnessed a significant increase toward geographic expansion in conducting clinical trials. It has become routine to target regions in E. Europe, Asia and Africa. These areas allow the recruitment of large patient populations that are no longer available in the USA. For clinical research teams, these opportunities require that cultural and language barriers need to be overcome while working with challenging regulatory environments and adhering to good clinical practice guidelines.
8:30 Barnett Welcome and Introductions
8:35 Chairperson’s Welcome and Opening Remarks
8:45 Maximizing Training Resources across Clinical Research Job Functions
Herb Anthony, Associate Director, Clinical and R&D Training, MedImmune, Inc.
With the ever-changing climate of the Biotechnology/Pharmaceutical industry it is becoming the business norm to maximize the use of a limited training budget. This presentation will offer proactive solutions to managing with less. Included are approaches for assessing existing talent to maximize productivity, and leveraging internal and external resources while ensuring that the quality and effectiveness of the training program stays intact.
9:30 Optimizing CRA Training: Case Studies, Lessons Learned and Examples
Danielle Hoskins, Senior Manager, CMR Training, Novo Nordisk, Inc.
As part of Novo Nordisk’s new blended “on-boarding” training strategy for CRAs, a four phase program was created to develop a strong foundational structure for new hires that is then built on through classroom activities to the final on the job pull through of knowledge. This customized training plan incorporates learning about company SOPs, processes, values/culture, systems administration and local procedures and uses Instructional Design and Adult Learning principles. Attend to hear how the Novo Nordisk training team built an experiential new hire experience for our field and in-house CRAs.
10:15 Coffee Break with Exhibit Viewing
10:45 “iReady”: Design and Methodology in Online Trainings to Ensure Engagement, Fun and Learning Transfer
Gerlinde Jayme, Head, Continuous Learning & Development, Global Clinical Operations, EMD Serono
Cécile Nicolas-Denizou, Global Training Manager, Continuous Learning & Development, Merck Serono
For international companies operating worldwide and across various locations, e-learning is the most cost effective way to ensure global training coverage, especially for compliance relevant topics. However, designing an interactive and memorable e-learning event that is not only informative but also keeps trainees engaged throughout the session can be a challenging task - a poorly designed training will result in less information retained by the learner and can lead to a general negative attitude towards e-learning. In the frame of an overall inspection readiness program, EMD Serono has developed 2 e-learning programs (1 high budget, 1 low budget) covering general, but also behavioral aspects in order to prepare staff for an inspection.
11:30 Roundtable Discussions and Group Feedback
Regulatory Roundtable: How current inspection findings can be used to reinforce training objectives
Approaches to GCP Training: Lessons learned from industry experts
Performing a curriculum gap analysis for clinical research functions
Identifying, assessing and mentoring/training subject matter experts
Developing a culture of learning and achieving executive-level buy-in for your programs
Strategies for maximizing training resources in small- to mid-sized companies
12:15pm Sponsored Presentation (Opportunity Available; contact Ilana Quigley firstname.lastname@example.org)
12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
» Interactive Session!
1:30 Writing Effective Test Questions: Did They Learn What We Think We Taught?
Karen L. Gilbert, BS, CCRA, Clinical Trainer & Curriculum Manager, Barnett Educational Services
As training resources in the clinical research industry are increasingly stretched, there is more emphasis on the ability to show the effectiveness of our training efforts. One method for evaluating the transfer of knowledge and core competencies is through the administration of knowledge assessments or tests to participants.
In this interactive session, a brief overview of the theory and “rules” for writing assessment questions will first be presented. Working in groups, participants will then be presented with test questions designed to assess knowledge and comprehension of a particular ICH E6 citation. Attendees will work collaboratively to re-write the test questions to satisfy the “rules” and adequately assess the training goal, before presenting their “new and improved” test questions to the larger group.
2:45 Site Training Considerations in Risk-Based Monitoring and Quality Management Systems
Amy Adams, Clinical Project Manager I, Clinical Monitoring Research Program, SAIC-Frederick, Inc.
Denise M. Shelley, M.S., Clinical Project Manager II, Clinical Monitoring Research Program, SAIC-Frederick, Inc.
This presentation will provide an analysis of the data collected from monitoring visits (findings and observations) demonstrating how risk-based monitoring plans are developed and how this data can also be used to develop training to sites on implementing quality systems. With a Risk-Based Monitoring approach there will be a reduction in time that monitors spend at each site and the frequency that they visit each site. In this presentation, we will demonstrate how we develop and execute a risk based monitoring plan based on site observations and findings, then in turn offer a wide variety of training to assist site staff in developing their quality systems approach based on the findings.
3:30 Refreshment Break with Exhibit Viewing
4:00 Creating and Deploying a Good Clinical Practices (GCP) Program for Clinical Research Professionals at a Large Medical Device Company
Catherine Carey, RN, BSN, Senior Clinical Quality Training Specialist, Global Clinical Operations, Medtronic, Inc.
We will review the development, deployment and lessons learned from creation of a Good Clinical Practices Program for clinical research professionals across nine business units of a large medical device company. Topics to be covered will include techniques and processes employed and lessons learned over the course of information gathering, subject matter expert interviews, collaboration with instructional designer, uploading of the course to the learning management system, actual rollout of the course, as well as course management and compliance tracking. Cost comparison of internal development vs. outsourcing the course will also be covered.
4:45 R.E.D.™: Rapid Educational Development Process™
at Duke Clinical Research Institute
Michael L. Bishop, MS, CLS (NCA), Senior Learning Consultant, Organizational Learning, Duke Clinical Research Institute
In today’s world of clinical research, development of world class educational events and materials can be a time-consuming process. Competing clinical trial responsibilities for subject matter experts often makes the process inefficient. At Duke Clinical Research Institute, we pioneered the concept of a Rapid Educational Development Process™ patterned after Rapid Improvement Events. R.E.D.™ is an all-day event with the appropriate subject matter experts focused on the task of developing an educational module. Planning and preparation for the event by the facilitator is key to success. A R.E.D.™ is a carefully executed series of steps to ensure maximum benefit and efficiency for the development team and subject matter experts. DCRI’s first event resulted in the near completion of an educational unit related to forecasting resources and non-labor expenses for government trials. This presentation will review the R.E.D.™ process, the outcome and lessons learned from this project.
5:30 Networking Reception with Exhibit Viewing
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