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Tuesday, June 3, 2014

7:30 am Breakfast Presentation: Employing an Innovative Risk-Based Monitoring Approach: A Case Study

Meredith Mundy, Director, Clinical Operations, Patient Profiles, LLC.

A risk-based monitoring program looks good on paper, but without the tools to incorporate centralized monitoring, implementation can be a challenge. We review an ongoing randomized clinical trial employing an innovative risk-based approach to data monitoring. This approach is based on advanced statistical methods and a clinical review of graphical patient reports to identify unusual or suspicious data in need of monitoring.

8:10 Chairperson’s Opening Remarks

Emily Cantrell, Senior Project Manager, Rho

8:15 Monitoring in the Electronic Environment: Electronic Data Capture (EDC), Electronic Medical Records (EMRs), and Electronic Storage Systems

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

Monitors continue to struggle with how to source document verify study data of sites dependent on Electronic Storage Systems EMRs and hybrid EMR/hardcopy medical record systems. The issue will only intensify as more and more organizations move to the utilization of EMRs. In addition, some study data is now being captured directly onto electronic platforms, thereby adding another layer of complexity. A primary task of monitoring is to ensure the data meets the ALCOA principals of accountability, legibility, contemporaneous, original, and accurate study data. This session will focus on the three different types electronic systems, describe the how each is used within a research setting, and provide some practical considerations when monitoring in the electronic age of data capture and management.

9:00 Quality by Design: A Lean Six Sigma Approach to RBM

Erika Stevens, Senior Manager, Advisory Services Health Care, Ernst and Young LLP

This session will demonstrate traditional project management methodologies to create and manage a compliant CAPA monitoring system within the QMS. The conventional project management (PM) elements of Initiation, Plan, Execute, Monitor/Control, and Close will be defined as they relate to the CAPA monitoring system. Specifically, identification of non-conformances vis-à-vis routine quality control monitoring procedures will be defined and mapped within the Initiation PM element of the CAPA monitoring system. Analysis and creation of the non-conformance corrective and/or preventive action via root cause analysis will also be defined and mapped to the Plan PM element of the CAPA monitoring system. Initiation of change controls will be mapped to the Execute PM element and implementation of pre-defined measured CAPA progress will be mapped to the Monitor/Control PM element.

9:45 Coffee Break and Exhibit Viewing



10:05 Site Relationship Management: A CRA’s Perspective

Sharon Sothern, BA, CCRP, CRA, Westat

Maintaining a perfect relationship balance between the Clinical Research Associate (CRA) and site can be tricky. The CRA must recognize the importance of professionalism and understand how a site’s perception of a CRA can influence site interactions. Having respect for one another and effective communication are the main components of a successful relationship. Once the site relationship is established the CRA must know how to build trust. The CRA and site are a team and both want to produce quality research. This presentation will use real-life scenarios to demonstrate how positive working relationships can be developed at the beginning of a new project and improved, should the relationship start to decline.

10:50 Assessment Tools for Triggered Monitoring Visits

Lesli DeSimone, MSHS, RN, CCRA, CCRP, Clinical Monitoring Manager, Medtronic, Inc.

Based on language in the FDA’s Risk-Based Monitoring Guidance, sponsor staff must ask themselves, “What does this really mean and how can I practically apply this to my studies?” Your speaker will discuss and share tools to help determine what is “critical” for your study and what type of monitoring activities are available to provide “effective oversight.” These tools will include site evaluation to determine an analysis of the information you have regarding selected sites and the potential influence they have on study time. We will also discuss a datapoint evaluation tool that will help you determine what data is critical to evaluate to reach your goals, and which data is not so critical and how to show an evaluation of these points.

11:35 Principal Investigator GCP Training – Maybe It Is Rocket Science!

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

At this time of increased scrutiny of clinical research conduction, training Principal Investigators to understand their important legal and ethical responsibilities is critical... and challenging! Building on the principles of GCP, the presenter will offer real world case examples of PI non-compliance and challenge the audience in how to properly respond. Referencing the FDA CFR and ICH GCP, the audience will work together to identify PI non-compliance in the case studies presented, and determine how it should be reported and to whom. In addition, the presenter will aim to help the audience identify and train PIs to recognize the easily avoidable pitfalls in order to avoid non-compliance, because it shouldn’t be rocket science!

12:20 pm Close of Conference

1:00 Short Course Registration

1:00 – 3:30 Short Course 2, Metrics & KRIs: Study Oversight in a Risk Management Environment – How to Make It Work! (see Short Courses for additional information)

6:00 – 8:30 Short Course 3, Managing the CRO Relationship: From Engagement through Delivery (see Short Courses for additional information)


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