Clinical Protocol Development Track 

Virtual Investigator Meeting Management Track 

Clinical Training Forum Track 

Clinical Project Management Forum Track 

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2012 CTD Barnett's Clinical Summit Brochure
2012 Final Brochure

Short Courses 

Wednesday, October 10 – Dinner

Proactive Approaches to Vendor Management (5:30 pm - 8:00 pm)
Michael J. Harte, Founder and President, The Harte Group

Vendor management and oversight is now one critical FDA and EMA audit finding. Is your clinical team proactively managing your vendors in order to prepare for these audits? This interactive session will provide valuable and useful tools and techniques to develop corrective and preventive action (CAPA) quality systems, Total Quality Management processes, and integrative management techniques to prepare your organization to better manage your vendors in a compliant manner. In this workshop, we will review approaches to the following activities:

  • Designing a vendor qualification program
  • Developing a vendor management plan
  • Developing integrated vendor/sponsor processes
  • Identifying and implementing on-going quality checks to ensure deliverable quality
  • Determining quality measures for vendor deliverables
  • Developing deliverable standards for vendor work product
  • Processes and standards to analyze the vendor's infrastructure and staff assigned to the study
  • Developing a program to manage risk, escalate issues, and effectively collaborate with the vendor
  • Case Study: Investing in a vendor/sponsor strategic alliance: A proactive method to ensure quality across all functions in clinical operations
  • Managing the shifting internal responsibilities of staff in an outsourced environment; the use of tools such as RACI, integrated process flows, and the development and identification of new skills for internal staff

Design Considerations for GCP Training Programs (5:30 pm - 8:30 pm)
Karen L. Gilbert, B.S., C.C.R.A., Clinical Trainer and Curriculum Manager, Barnett International

Regulatory authority inspection trends are identifying a need for truly effective Good Clinical Practice (GCP) training. GCP training should ensure that clinical research stakeholders not only “know GCP” but know how to apply the principles of GCP in their work lives. The decision to develop and implement a GCP Training Program is a time-consuming and expensive project for any clinical research organization. How can you maximize the effectiveness of the training to ensure return on this investment in both financial and compliance terms? By designing GCP training with a focus on engaging adult learners, which is critical to ensuring both acceptance by the learners and the transfer of knowledge into everyday professional practice. This interactive course will identify key elements to consider throughout the phases of program development and design, training deployment, and post-course assessment.

  • Describe the training elements that effectively “connect” with adult learners
  • Compare and contrast the pros and cons of face-to-face, web-based, and eLearning venues for GCP training
  • Identify strategies for assessing training outcomes such as short-term knowledge transfer and long-term impact on the organization

    *Separate registration is required to attend a short course. 
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