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Mastering Clinical Trial Monitoring - Day 1

Conference Proceeding CD Now Available
  • Speaker Presentations
  • Poster Abstracts
  • and More!

Monday, June 13, 2011

7:00 am Registration and Morning Coffee

8:00 Welcome & Chairperson’s Opening Remarks


8:15 Risk-Based Monitoring in an Evolving Regulatory Environment

Sharon S. Reinhard, M.S., Associate Director, Clinical Quality Control, Endo Pharmaceuticals

The regulatory climate has changed dramatically in the last few years. More GCP inspections are occurring at the investigator, site, and sponsor level than ever before, with more 483s and Warning Letters being issued than in the past. The old monitoring techniques and lengthy monitoring reports of the last few decades are no longer effective. We need to monitor strategically with focus and with a risk-based mindset. ICH guidelines have always acknowledged a sampling approach to monitoring, and FDA has acknowledged that it is no longer feasible to monitor 100% of everything. This session will bring you back to the original purpose of monitoring, and suggest new and innovative ways to monitor and leverage technology.

9:00 Creating and Implementing a Global Risk-Based Monitoring Plan: Planning for Success

Maggie AyersMaggie Ayers, B.Sc., Director, Clinical Study Management, Astellas Pharma Global Development, Inc.

“Playing to win is very different than playing not to lose.” This concept can be applied to standard clinical study monitoring plans which typically present global monitoring expectations that include activities incorporating sponsor SOP requirements and regulatory guidelines. With the development of electronic technologies and integration of electronic data capture systems allowing for remote “central” monitoring, traditional monitoring plans can be adapted to consider predefined protocol-specific factors which prioritize on-site monitoring activities. This session will incorporate a facilitated group discussion and interactive case study simulation to discuss global monitoring risk assessment factors and monitoring models which are tailored to protocol-specific requirements. In addition, examples of risk-based monitoring plans will be reviewed.

9:45 Networking Coffee Break and Exhibit Viewing

10:15 A Quality Systems Approach to Ensuring GCP Compliance

John Creech, CCRP, Clinical Research Associate, Clinical Operations, Abbott Vascular

Quality Assurance (QA) and Quality Control (QC) are the two basic processes of an overall clinical quality system. This presentation will define these two processes based on definitions provided in the regulations. We will discuss study-specific examples to illustrate how a sponsor can use a clinical quality system to ensure GCP compliance and “inspection readiness.” According to the regulations, the sponsor is responsible for implementing and maintaining quality assurance and quality controls systems. This presentation will provide the audience with a basic understanding of what the regulations require and how to implement a system that will better prepare their organization to meet the requirements. The audience will become more familiar with the regulations and a quality systems approach through study-specific examples.

11:00 Yes, There’s a Monitoring App for That!

Feargal Mc Groarty, National Haemophilia System Project Manager, IMS Department, St. James’s Hospital

Mobile technology can be leveraged to provide the tools required to implement initiatives that can improve clinical trial compliance and support a rapid real time recall. A smartphone application and a simple barcode can be used to monitor compliance, optimize supply chain efficiency, and reduce costs. The smartphone autofocus camera can be used to track medication, gather clinical information, increase recording compliance, and alert the patient to potential hazards with respect to their medication. This session will present a real-life case study in which a mobile phone application (app) is being used for hemophilia patients. The initial phase of the study has demonstrated that it is conceptually and technically possible to design, develop, and implement a medication management system that integrates smartphone technology, barcode scanning, and an electronic diary to record and optimize medication compliance for patients.

11:45 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own



1:00 pm Site Perspectives on Monitors and Monitoring: What Makes a Bad Monitoring Experience?

Angelia Drake, RN, Surgical Oncology, Baylor Health Care System

This session will assist both the coordinators/sites and sponsors/study monitors in understanding both sides’ perspective in clinical research. As a former research nurse coordinator and industry-sponsor Sr. Clinical Affairs/ Operations Manager, your speaker understands the demands on both sides of the fence, along with the various levels of relationship building, communication and negotiating skills, knowledge, and experience required to effectively monitor and ensure good science behind the study product or study idea, which translate into the need for expert monitoring and buy-in from the site. Often monitors skip the relationship building and explanation of rationales, or fail to understand the site’s flow and dynamics. This can create an unsuccessful and bad monitoring visit. This session aims to foster an understanding of the expectations and limitations of both sites and sponsors, and improve site monitoring visits.

1:45 Research Sites Perception of Monitors: Good Cop or Bad Cop?

Nancy BakkeNancy Bakke, Principal Clinical Study Manager, Clinical Research Monitor, Sorin CRM USA, Inc.

Research centers are rapidly evolving, requiring more from their sponsor monitors. As monitors, we all want to know how we can better serve our sites. The audience will get a wake-up call on things we probably all do, but never knew (or were told) were irritating to sites. During this presentation, we will discuss the results of a recent survey of more than 50 research coordinators in which they were asked to give feedback regarding site monitors. We will specifically discuss: The Good, The Bad, The Ugly, and The Humorous. We will conclude with a role playing exercise regarding a serious issue (informed consent), and explore the various ways to address the issue with the Investigator and research coordinator: the wrong way, the easy way, and the right way.


2:30 Troubleshooting Difficult Sites: Strategies for Achieving Compliance

Marsha (Toby) Johnston, RN, BS, CCRA, Clinical Operations Manager – Oncology, US Clinical Operations, CSO – Development Operations, Pfizer Worldwide Research and Development

Alana Chenault, Clinical Operations Lead – Oncology, US Clinical Operations, inVentiv Clinical Solutions, On Assignment with Pfizer Worldwide Research and Development

Keri-Ann Heck-Winters, RN, BSN, CCRA, CCRC, Clinical Operations Lead, Manager, US Clinical Operations, Pfizer Worldwide Research and Development

Troubleshooting difficult sites requires a comprehensive, holistic, strategic, and tactical directive to foster protocol adherence, regulatory compliance, data integrity, and ultimately, inspection readiness. It also requires an understanding of the question: “How does a site become difficult?” This presentation will examine and discuss this issue from the standpoint of three pivotal players: sponsor, site coordinator, and site monitor. The primary goal of the presenters will be to identify and assess root-cause analysis of the most significant factors that contribute to the concept of a “difficult site.” A secondary goal is to provide attendees will a balanced and comprehensive understanding of those behaviors and study-inherent characteristics that so easily and often result in what is referred to as a “difficult site.”

3:15 Networking Refreshment Break and Exhibit Viewing

3:35 Utilizing Adult Learning Principles to Strengthen Site Relations

Carol Opalek, Clinical Research Associate, Abbott Vascular

This session will offer an overview of adult learning principles, styles, and communication techniques that can be employed to help strengthen our site relations. An understanding of these principles and techniques is a valuable “soft” skill that can promote more optimal outcomes between both our sites and our colleagues. Examples of these techniques will be offered through vignettes, such as at interim monitoring visits, site initiation visits, and at investigator meetings. Objectives of this session include:

  • Identify at least two common adult learning principles
  • Identify at least two different learning styles
  • Identify at least one way to utilize these techniques at a site visit


4:20 Root Cause Analysis: Getting Beneath the Surface to Implement Effective Corrective Action

Linda S. Barnes, MHA, RAC, Director, Apheresis Network, Dendreon Corporation

Ideally, corrective actions resolve past and future problems. All too often, corrective actions are explanations of why mistakes happened but do little to prevent the problem from happening again. This session will explore the use of root cause analysis as part of an effective corrective action plan, including the use of tools and documentation designed to prevent mistakes from happening again in the future. Specifically, we will cover:

  • Introduction of RCA and the relationship to CAPA: Rationale, purpose, outcome
  • Common tools for RCA: Fishbone diagram, the 7 why’s, Plan-Do-Check-Act (PDCA) cycle
  • Documenting CAPA: Writing and measuring your plan


5:05 Wrap Up

5:15 Reception and Exhibit Viewing (Sponsorship Opportunity Available)

6:15 Close of Day One

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