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Clinical Trial Oversight Summit
Archived Content

Fourth Annual | June 3 - 4, 2013
Mastering Clinical Trial Monitoring

The Premier Event for Experienced Clinical Trial Monitors

Day 1 | Day 2 | Download Brochure 

Tuesday, June 4, 2013

7:30am Morning Coffee or Sponsored Breakfast Presentation (Opportunity Available)


8:00 Avoiding FDA Inspection Land Mines: Preparing for and Surviving FDA Inspections and Potential Outcomes

Lee Truax-Bellows, President, CEO, Clinical, NCRA

FDA Inspections within the US for sites, sponsors, and vendors assisting in the conduct of drug, device, and biological clinical studies are a given. Regretfully, not all participants have an understanding of what such an inspection curtails or how to handle any resulting fallout. This presentation will provide an overview of preparing for an FDA Inspection and how to handle the potential outcomes. It is of extreme importance for these same participants to be prepared in responding to any resulting inspection citations in order to ensure issues do not escalate and place the organization being inspected in a poor light with the FDA. This presentation will assist those groups with obtaining the knowledge they need to avoid those land mines.

8:45 Dictating for Clinical Trials: How Do We (Can We) Re-Train the PI?

Nancy S. Bakke, Manager, Clinical Monitoring, US/Canada, Sorin CRM USA, Inc.

Many FDA warning letters to investigators contain findings of “inadequate case histories (dictated notes) to support data reported on the CRFs. These can also include failure to properly document history of previous disease; failure to document adequately protocol required medication stability; conflicting medical histories by different doctors; and wrong dates or no dates on dictated notes. Topics to be included in this session are:

  • How to approach the subject with the PI/study personnel
  • Tools for training
  • Can we incorporate this into the site initiation visits?
  • Examples of 483s related to case histories
  • Examples of “monitoring madness” due to poor case histories
  • If we can’t change their ways, ideas to rectify the problems

9:30 Networking Refreshment Break and Exhibit Viewing

9:50 Best Practices for Managing an Imaging Vendor

Sara Mochel, Clinical Research Assistant 3/Sr CRA, Clinical Operations, Medivation

The relationship with an imaging vendor is key to the overall success of an oncology trial. For many oncology trials, an imaging vendor is used to manage the progression free survival (PFS) endpoint for a trial. In today’s clinical research atmosphere, it is necessary to have this function centralized with an imaging vendor. As PFS is usually an endpoint, the management of the imaging vendor becomes crucial to the trial’s success. The audience will gain helpful tips for establishing a productive and successful relationship with an imaging vendor.


10:35 Is There an App for That? Wireless Technology Utility in Clinical Trial Management

Sandra Lawson, Research Coordinator, Pathology, University of Florida Health System

The prevalence of smartphones and computer tablets has created opportunity and risk for managers of clinical trials. This presentation will objectively examine these technologies and associated applications. This subject is particularly timely for the research community as both hardware and software continue to evolve at a dynamic pace. This presentation allows for the critical analysis and interactive dialogue about the use of such technologies in organized research.

11:20 Techno Savvy Defines the New Clinical Research Professional

Penelope Manasco, M.D., CEO, Executive, MANA Consulting LLC

Risk-based monitoring and electronic systems completely changes the role of the monitor and how studies are set up and delivered. This session describes the processes and software used to deliver the FDA’s risk-based monitoring guidance and the use of electronic source. Actual examples of the implementation process and the metrics associated with the implementation will be provided. Participants will come to understand what is necessary to adopt this approach. This presentation provides actual examples of the implementation and describes what the monitor of the 21st century needs to know.

12:05pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:20 Global CRA Study Establishing Baseline for Workload, Tasks, and Time Utilization

Mary Jo Lamberti, Ph.D., Senior Project Manager, Tufts Center for the Study of Drug Development

Tufts Center for the Study of Drug Development, in collaboration with 18 biopharmaceutical and CROs, conducted a working group study in 2011 of the global CRA landscape examining key metrics, including workload and time utilization. Both company data and CRA self-reported data were collected. A total of 3,970 CRAs completed the self-report survey. The results indicate that CRA workload is high and assigned tasks vary widely by geographic region. This session will present detailed workload and utilization measures and discuss the implications of the study results. An understanding of the data from this important baseline study will enable industry stakeholders to make the appropriate decisions to drive improvements in CRA effectiveness and efficiency.


2:05 Monitoring International Clinical Trials in Emerging Countries

John R. Wilson, Jr., Ph.D., MPH, Senior Vice President, Beaufort CRO

Prior treatment of this topic has focused on “what is different” about monitoring in emerging countries, and there is a wealth of information outlining such differences. What has historically been missing, however, is “what to do about it.” This talk will delve into the differences and challenges with an eye toward constructive, proactive approaches that help ensure that regardless of difficulties, sponsors can come to count on data from emerging countries.

2:50 Networking Refreshment Break and Exhibit Viewing

3:10 Principal Investigator Responsibilities and GCP: The Essential Ingredients for Success

Shari Zeldin, BA, CCRC, Manager, Clinical Research Compliance Office University of Wisconsin Carbone Cancer

This presentation will outline the responsibilities that a Principal Investigator commits to when conducting clinical research. This session will address: Review of 21 CFR 312 Good Clinical Practice - The Standard; the protocol; informed consent; eligibility determination; treatment/adverse events/toxicity; data quality; audits/monitoring; and leading by example

4:10 Close of Conference

Day 1 | Day 2 | Download Brochure