Clinical Training Forum - Day 1



Monday, February 3, 2014


DINNER SHORT COURSE*:  

Tools for Trainers: Clinical Research Job Aids and Checklists


As adult learners, clinical research professionals are motivated by an understanding of how training interactions directly impact their work lives. The use of job aids and checklists can serve to satisfy this need by providing a resource to someone performing a task exactly when and where they need it. These tools can also serve to reinforce the training as participants return to the workplace, resulting in a greater likelihood that the organization’s performance goals will be met. In some cases, a job aid alone can replace unnecessary training expenses. This course includes a decision-making framework about the use of job aids as standalone training objects versus as a complementary tool to existing training programs. Sample tools that may be appropriate for various clinical research audiences will be discussed.

Instructor:
Karen Gilbert, Clinical Trainer and Curriculum Manager, Barnett International


* Separate registration required


Tuesday, February 4, 2014

8:00 am Barnett and Chairperson’s Welcome and Opening Remarks

8:15 Meet Your Colleagues – Introductions and Identifying Collective Goals and Challenges

8:30 Why Train? What FDA Warning Letters Tell Us

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

As the FDA’s scrutiny of the qualifications of clinical research professionals based on the CFR increases, the need for accountable, effective, documented training simultaneously increases. This presentation will include a summary of the trends in FDA Warning Letters and other FDA communications and suggestions to correct and avoid citations. Although the CFR is fairly vague on the FDA’s expectations on training, training professionals are responsible for delivering training that is effective, and also meets the FDA’s expectations. This presentation will tie FDA expectations to effective deliverables.

  • Identify the areas of the CFR that describe the FDA’s expectations for training in the clinical arena
  • Explain the trends in FDA Warning Letters, based on actual citations
  • Design their training system to avoid citations in FDA Warning Letters that focus on training

9:10 Case Study! From Audit/Inspection Findings to GCP Compliance: How Education and Training Bridge the Gaps

Lisa Johnston, Research Training Coordinator, Research Services, Centre for Addiction and Mental Health

This presentation focuses on the development, implementation and lessons learned from the creation of a mandatory and supplementary education and training program. The aim of such a program is to ensure quality research so that all research conducted is consistently performed to high ethical and scientific standards and to support compliance with regulatory requirements, research best practices and institutional policies and standards. The presentation is based on real life experience of the presenter, and will cover topics such as: starting with a gap analysis (assessing the current culture), benchmarking, identifying which approaches to take with training (use of audit/inspection findings), developing plans to maximize existing resources, identify challenges and barriers to training, implementation and knowledge sharing and finally introducing a new Mandatory Education and Training policy for research.

  • Share best practices around training and GCP compliance through lessons learned
  • Understanding the challenges/benefits of implementing a training program
  • Develop a quality research training and education program

9:45 Grand Opening Coffee Break in the SCOPE Exhibit Hall

10:45 Making it Meaningful: Translating Audit Findings into Training Opportunities – A Hands-On Practice Session

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

Very often the results of audits are not disseminated or communicated to those who can have the greatest impact on learning from them to secure compliance, and audit-specific findings are often not integrated into corrective and preventive action plans in a meaningful “real-world” way. In this session, you will have the opportunity to gain practice in reviewing audit findings and distilling the key compliance elements that should be examined, while focusing on opportunities for creating meaningful training. How information should be received, reviewed, and disseminated, and who should be involved in the development and attendance of training will be discussed. Finally, we will review real-life examples of how adult learners can benefit from this approach and use information learned to direct their efforts.

11:30 Case Study! Standardizing and Automating Clinical Training Requirements across Multiple Clinical Research Professional Functions

Gina Calistro, Senior Training & Development Specialist, Global Clinical Operations Quality Training, Medtronic MCRI

Statistics show that new employees who participated in a structured on-boarding program were 58% more likely to be with the organization after three years (Moscato, 2005). The first few weeks in a new position often create a lasting impression for new employees. We will present how Medtronic Clinical Research Institute (MCRI)’s clinical training group defined an optimized onboarding process for new clinical research personnel. It will include a review of the working group process, and how key team members were leveraged across the multiple clinical functional departments to drive the initiative. The clinical training structure (phased approach) will be explained, including matrix creation, implementation and deployment of the clinical research professional’s onboarding program. Additional topics to be covered will include techniques and processes employed and lessons learned over the course of information gathering, subject matter expert interviews, and risk analysis review of audit findings related to training. Developing and evaluating effectiveness of core competency training will also be presented, specifically SOP review and how to make it less dry and more engaging. Lastly we will demonstrate leveraging a learning management system (LMS) to deploy an onboarding program to a large audience, how to track progress and report completion metrics.

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

1:30 Training Clinical Trial Sites on Quality Control- An Analysis from Risk Based Monitoring

Amy Adams, Clinical Project Manager, Clinical Monitoring Research Program, SAIC-Frederick, Inc.

This presentation provides insight on the high-risk areas of clinical research and training techniques and their impact on quality control. Included is a data review from Risk-Based clinical monitoring visits and analysis on the findings and observations noted. It will be shown that by applying this analysis, focus is placed on monitoring these high-risk areas and training the sites to ensure they have well-established procedures before the start of the study. In this presentation, these specific areas of high risk, training procedures to prevent them, and specific examples of errors noted will be highlighted. Examples of poor corrective and preventive action (CAPA) plans and examples with very successful plans will be spotlighted. A recently developed tool to help sites create effective and efficient plans will be also provided to all participants. Furthermore, participants will be provided with a tool that can be used in the future when managing CAPAs.


CRA Training Solutions Approaches and Case Studies! 

2:15 Training CRAs Today: Considerations in a Time of Change

Dr. Julie Opiteck, Senior Learning Consultant, Organizational Learning, Duke Clinical Research Institute

Duke Clinical Research Institute (DCRI) is a full-service academic research organization with a team of over eighty Clinical Research Associates (CRAs) that provide a variety of in-house site management, remote and on-site monitoring services for their clinical trials. The role of the CRA is currently in transition to accommodate “risk-based monitoring” strategies. Monitoring plans are shifting to reflect decreased on-site visits, and increased in-house monitoring and site management. CRAs have to be adaptable, as does the training for those employees. This presentation will outline the blended learning approach of the core Clinical Research Monitoring course at DCRI. Special attention will be given to instructional strategies that emphasize critical thinking and problem solving in support of a risk-based model. Topics will include:

  • The power of pre-work assignments
  • Scenario-based learning
  • Mock site visits
  • Effective discussions with sites
  • Creative use of games/activities for knowledge checks

3:00 Refreshment Break in the SCOPE Exhibit Hall

4:00 Bridging the CRA Resourcing Gap

Suzanne Day, Director, Clinical Operations, PRA International

In 2011, the need for CRAs rose significantly and CROs began a feeding frenzy to hire CRAs. Hear how one company, in addition to hiring CRAs, took a different approach by looking for people such as medical professionals or study coordinators, and trained them to be CRAs through a comprehensive training initiative. This presentation describes how the program was implemented, and the steps required to obtain sponsor approval to use these trainees in their studies. Included is the method currently used to provide a continuous feeder pool of qualified and enthusiastic CRAs.

4:45 CRA Accreditation: Setting a Global Standard for Monitoring

Tammi Masters, Manager, Global Clinical Training, INC Research

Anecdotal evidence is suggesting that auditors are now focusing on the content and method of the training that monitors receive, looking at the quality rather than the quantity of training. However, sponsors commonly lack an evidence-based decision making process for selecting quality monitors to monitor their trial. To date, the clinical research industry has yet to develop a global standard that defines a monitor’s level of competency; however, a focused CRA accreditation initiative can set a standard that meets both objectives. CRA accreditation means defining a globally recognized standard of competence as evidenced by completion of rigorous classroom training coupled with verification of performance and application of principles through a quality-assured accreditation. This session will provide a case study of how a company instituted a CRA accreditation program in an effort to define a “gold standard” of monitoring competence.

5:15 Welcome Reception in the SCOPE Exhibit Hall



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