Clinical Training Forum - Day 2

Wednesday, February 5, 2014


What the Warning Letters Tell Us: Recent Trends in Noncompliance

As the clinical research environment evolves in response to both internal and external changes, regulatory agency communication appears to be focused on particular areas of GCP compliance. Recent findings for Clinical Investigators, sponsors, and Institutional Review Boards (IRBs) tend to reflect historic areas of noncompliance; however, more attention is being placed on ensuring that corrective and preventive action plans, including training, are developed to secure compliance. This course will examine the trends in recent regulatory communication and will include open discussion for review of acceptable versus unacceptable responses.

Elizabeth Ronk Nelson, Clinical Trainer, Barnett International; Principal, Regulatory Risk Management, LLC

* Separate registration required

Strategies for Investigator Training 

8:10 am Investigator Meetings - Turning a Challenge into an Opportunity

Chicquita Hatten, Director, IND Office, University of Texas MD Anderson Cancer Center

Investigator meetings occur throughout the lifecycle of a clinical protocol. From study initiation, routine monitoring meetings, meetings to secure compliance in specific areas, to study closeout, these meetings can be an opportunity to provide education, build relationships, and maximize compliance. Including research team members can improve communication and cooperation within the team as well as with monitors or auditors from institutional regulatory offices. Hear how one academic IND sponsor uses investigator meetings to enhance performance and compliance.

Strategies for Designing Clinical Training that is Engaging and Memorable 

8:40 Interactive Techniques – Strategies for Making Training Memorable and Fun

Nancy Giard, Training Manager, Communications & Training, Global Services Division, Sanofi

9:25 Sponsored Presentation (Opportunity Available)

9:50 Coffee Break in the SCOPE Exhibit Hall

10:50 Interactive/Roundtable Session: Using Technology to Increase Engagement in Training

In this interactive session, we will explore the potential for enhancing participant engagement through greater integration of technology into clinical research training projects. The session will include demonstrations and hands-on experience of a sampling of technology options available to instructional designers and facilitators. Participants will be encouraged to share their own successes and challenges with greater use of technology. Attendees will walk away from this session with the following benefits:

  • Insights into the advantages and disadvantages of using technology in training
  • Sharing creative ideas with industry colleagues for enhancing engagement through technology
  • Strategies for using technology on a shoestring budget

12:10 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

Virtual Training Strategies: Making the Most Out of Virtual Learning 

1:30 Virtual Training for Investigative Site Staff: Strategies for Communication, Engagement and Ensuring Participation

Juliet Anderson, Associate Director, R&D Learning, Bristol-Myers Squibb
Edward Kaplan, Learning Manager, R&D Learning, Bristol-Myers Squibb

In the current environment of economic caution and emphasis on productivity improvement, virtual trainings offer potential for enormous cost savings and provide superior tools for knowledge transfer. Feedback is immediate, and can be used for instant knowledge checks and for gathering data for future training needs. Virtual trainings can be produced as computer- or web-based modules for electronic access and archiving, and offer time-efficient solutions to training more investigator sites quickly and thoroughly. Hear how BMS has successfully implemented virtual Investigator training across therapeutic areas in a multi-national capacity, including how it leads to improved communication between sites and BMS. Virtual trainings help to eliminate many of the ‘extras’ associated with traditional, face-to-face IMs, and eliminate the need for financial tracking required by the US Physicians Payments Sunshine Act.

2:10 Virtual Training Considerations: Meeting Training Objectives and Learner’s Needs

Sophia Stewart, Associate Director, Clinical Training & Quality, BioMarin Pharmaceutical, Inc.

In the business environment, training virtually has become a standard in reaching remote or global participants. The need to create and deliver training that is both effective and engaging is key to ensuring that participants are able to learn and retain the information being presented. Implementing adult learning principles and making use of the available technologies is essential to meeting the needs of our learners globally. Virtual training is and should be more than an online slideshow. During this session, we will discuss effective and engaging training methods for delivering online education that meets training objectives and learners needs.

3:10 Refreshment Break in the SCOPE Exhibit Hall

Approaches to GCP Training: Lessons Learned from Industry Experts 

4:00 Good Clinical Practice Training – From Knowledge to Application

Benetta Walker, Senior Learning Consultant, Organizational Learning, Duke Clinical Research Institute

There is no dispute that clinical research professionals must have training on and an understanding of the principles of Good Clinical Practice (GCP). While suitable for those early in their clinical research careers, training that simply offers more knowledge isn’t enough for senior staff. Next-level GCP training needs to challenge a participant’s understanding of that knowledge as well as their critical thinking and application of GCP in their roles. This session will describe the design, development and delivery of an Applied GCP course that encourages and demonstrate to trainers how to take their GCP training to the next level.

4:30 Influencing without Authority: Having Your Voice Heard

Barbara van der Schalie, Clinical Training Manager, Clinical Monitoring Research Program, SAIC-Frederick

Effectively exercising influence, even when you may not have the formal authority to mandate action is a challenge many of us face in our daily work, especially as training professionals. Successful training professionals build networks of relationships with stakeholders and influencers. This session introduces the skills necessary to employ these interpersonal and leadership skills to ensure that your training agenda is not only considered but actively requested. The presenter will also suggest ways to develop your capability to assess and increase your influential power to accomplish your training objectives.

  • Differentiate between influence and authority and list and explain the different sources of influence
  • Identify critical personal skills involved in influencing
  • Explain the how to apply the important aspects of influencing to training

5:00 Lessons Learned and Recap of Key Concepts

5:20 Close of Conference - Networking Reception in the SCOPE Exhibit Hall

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