2015 Archived Content

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Changing FDA expectations, risk-based monitoring, and ever-growing demands for cost efficiency are fueling dramatic developments in the world of clinical research. Clinical trial monitors are on the front line of these changes, and must adapt to the world of centralized risk-based monitoring, quality systems-based approaches, and sophisticated technologies designed to improve outcomes. CHI will be addressing these issues at its sixth annual Mastering Clinical Trial Monitoring conference. Participants can expect to hear from thought-leaders to share their insights into addressing these challenges and exploiting these opportunities via presentations, case studies, and hands-on activities.

Monday, June 1

7:00 am Registration and Morning Coffee

8:00 Welcome & Chairperson’s Opening Remarks

8:15 Risk-Based Monitoring Industry Survey Results

Linda B. Sullivan, Co-Founder & President, Metrics Champion Consortium (MCC)

In this session, we will discuss results from the Metrics Champion Consortium (MCC) surveying regarding risk-based monitoring, and answer questions, such as:

• What models are being piloted/adopted?

• Why are they adopting them?

• What metrics are they using as risk signals?

• How has the RBM landscape changed since the 2008 CTTI survey?


8:50 Case Study: A Holistic Approach to Quality Risk Management

Angie Maurer, BSN, MBA, CCRA – Clinical Operations Consultant, Gilead Sciences, Inc.

Brian Nugent, BSN, DC – Associate Director, Clinical Operations, Gilead Sciences, Inc.

Siloing in organizations causes individuals to not understand the full processes and interdependencies of their operations. This is exactly why a holistic approach to risk management is important. Much attention has been paid to the concepts and day-to-day tools required to carry out Quality by Design (QbD) and QRM activities, however, many companies have not yet designed a holistic approach based upon the establishment of a unified quality and risk management framework within Clinical Operations. In this session, we will discuss:

• Gilead’s quality framework and sub-frameworks that address risk management and quality control

• The role of risk management training as a foundational element of risk management

• The role of risk management tools and Risk-Based Monitoring (RBM) within Gilead’s QRM framework

• The role of continuous improvement within the risk management system

• Quality and risk management implementation strategies and lessons learned

9:25 Combining Machine & Human Intelligence to Successfully Integrate Clinical Research Data

Timothy Danford, Ph.D., Field Engineer, Tamr Inc.

Multiple Clinical Research data sources must be integrated and unified to support biomedical analysis and decisions. However the standard, manual approaches to data curation are unable to scale to meet the growing size and complexity of this data. This talk will discuss new methods in data integration, combining the power and speed of machine learning with the accuracy of human expertise.

9:55 Networking Coffee Break and Exhibit Viewing

10:25 Quality by Design: A Lean Six Sigma Approach to Risk-Based Monitoring

Erika Stevens, MA, Senior Manager, Healthcare Advisory Practice, Ernst & Young, LLP

M. Peggy Fay, Ph.D., RN, CCRC, CRA, Director, Global Clinical Monitoring, Medtronic Clinical Operations, Medtronic, Inc.

Currently, no formal process or methodology exists to aid in identification of risk factors impacting monitoring practices. Furthermore, there is great variation in risk identification, analysis, and mitigation strategies throughout the industry. This results in extra manual work and duplication of effort, which in turn increase customer cost variation and create crisis management situations. This session will demonstrate traditional project management methodologies to create and manage a compliant CAPA monitoring system within the QMS. Conventional project management elements will be defined as they relate to the CAPA monitoring system. Concepts such as quality control monitoring procedures, root cause analysis, change controls, resolution of CAPA, and supporting elements such as Scope Creep, Program Evaluation and Review Technique (PERT), Critical Path Analysis, and Gantt Charts will be discussed and mapped back to the project management element of the CAPA system.

11:00 Interactive Roundtable Discussions

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


1:00 pm Leveraging Inspection Focus Areas to Improve Site Quality

Jessica Masarek, Quality Assurance Consultant, Muse Clinical

In this session, we will explore key inspection focus areas and the practical application of ALCOA so attendees may apply this knowledge to site inspection readiness activities. Monitors will be challenged to consider ways in which they can employ these knowledge areas to improve monitoring and compliance and to better ally with their sites. We will share current examples from the field, explore common findings, and discuss best practices. Important questions will be addressed regarding documentation, preventing audit findings, and inspection readiness. We will also discuss practical approaches to ally with sites in their efforts to identify risk areas and increase compliance.

1:45 Preparing Your Clinical Trial Sites for FDA Inspections

Stuart Halasz, Associate Director, Clinical Quality Management, Merck Research Laboratories

This presentation takes a light-hearted empirical approach to using the BIMO guidance manual and common sense in helping CRAs and Project Managers prepare their clinical research sites for an FDA inspection. It is intended for those new to this activity and includes real-life examples of situations encountered at clinical sites during inspection preparation visits. Participants will take away practical ideas that can be applied immediately.

2:30 Case Study: The Challenges of Conducting Multicenter, Multicultural, and Multilingual Clinical Trials

Diarmuid De Faoite, Communication & Education Manager, AO Documentation and Publishing Foundation, AO Foundation

Working globally creates its own unique set of problems, and your speaker will consider them from multicenter, multicultural, and multilingual perspectives. The impact of culture on a study’s success is a real issue, particularly when patient reported outcomes form part of the trial. A trial which is conducted globally requires the use of local language material, but this is an element fraught with the possibility of mistranslation and misunderstanding. Going beyond the available literature on the subject, your presenters will share never-heard-before, first-hand global trial experiences at their academic research organization. Attendees will be sensitized to the many factors which may (negatively) impact on the success of clinical investigations conducted in different countries or cultures. Finally, we will discuss the composition of a research team working in this environment, and examine how to motivate them.

2:45 Sponsored Presentation (Opportunity Available)

3:15 Networking Refreshment Break and Exhibit Viewing

3:45 Engaging with Site Personnel during the Monitoring Visit: Identifying Changes, Retraining Needs, and Opportunities for Improved Research Practices

Megan Jung, Regional CRA Manager, Clinical Studies, BIOTRONIK

Too often monitors conduct the visit without holding meaningful conversations with the clinical research coordinator and principle investigator. However, monitors learn most at the site by having direct conversations about the study conduct. Monitors can identify changes in study staff by reviewing the DOA and IRB documents directly with the CRC. Monitors can evaluate the site’s informed consent practices with the CRC. Monitors can review site visits and conduct to confirm that the processes are in accordance with the protocol. Finally, monitors can identify non-compliance through conversations with the site staff. This session will demonstrate the value of engaging site staff to identify areas that need improvement in the site’s research practices that administrative document and subject records review do not convey.

4:20 Case Study: A Deep Dive into the Value of GCP Training: A Case Study

Rebecca Carew, Senior Manager – Process Management, Purdue Pharma L.P.

As a sponsor, we have a responsibility to train our investigators. This includes the fundamental training on Good Clinical Practices (GCPs), one component of the overall investigator training curriculum. This case study will discuss the process for assessing investigators for various levels of GCP training needs, assessing the investigator’s application of the training, determining when additional oversight and monitoring activities are required, reviewing the trends identified through the training assessments and the process and training improvements resulting from this analysis. The learning didn’t stop after the formal training was completed. The training served to be a good use of time and value to the investigator and the sponsor.

4:55 Reception and Exhibit Viewing

(Sponsorship Opportunity Available)

5:45 Short Course Registration

5:55 Close of Day One

Tuesday, June 2

7:45 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee

8:15 Chairperson’s Opening Remarks


8:20 Case Study: Use of Risk Based Metrics in the Selection of Clinical Study Sites: A Sponsor Perspective

Eddy Lyons, CCRP, Senior Clinical Research Associate, Clinical Studies Department, Biotronik, Inc.

Sponsors of clinical studies have several FDA-mandated objectives for the conduct of clinical trials, namely timely enrollment and a high level of compliance. Your speaker will discuss key attributes to consider during the selection of clinical sites from a sponsor’s perspective. Such elements as target patient population, competing studies, prior compliance history, experience and prior training of key personnel, workload, research program infrastructure, contracting and reimbursement timelines, and adequate study resources, among others. Your speaker will also present a site grading system using these metrics to target the best sites capable of contributing significantly to enrollment goals and providing high quality data.

8:45 Case Study: Dancing with the Stars: Engaging Academic Researchers in Industry-Sponsored Studies

Carol Breland, MPH, Research Recruitment Director, NC TraCS Institute, UNC Chapel Hill

Academic researchers are highly sought after for industry trials as they have extensive experience and expertise in their therapeutic area. However, getting a timely response to even a feasibility questionnaire can often be a frustrating experience for the project team! In this talk, you will learn more about the motivations and barriers that academic principal investigators experience, from personal goals to internal processes and approvals. You will hear best practices for initiating and building trusting relationships and get tips for improving your study start-up timelines. A case study will be presented on how an innovative listening approach has helped build a more productive partnership between an academic medical center and a CRO.

9:15 Sponsored Presentation (Opportunity Available)

9:30 Networking Coffee Break and Exhibit Viewing

10:00 Site Relationship Management: Keys to Successful Site Identification, Selection, and Ongoing Oversight

Linda Tedder, Director, US Clinical Project Management, Clinical Operations, DePuy Synthes

One of the key points for sponsors to consider during any clinical study is the successful identification -and selection of “good” clinical sites. Throughout the study, site management is key to ensure enrollment goals are met, continued adherence to the protocol, ongoing regulatory compliance, and overall subject retention. Problems will arise in any clinical study, and how sponsors manage the sites can impact whether a clinical study is successful or not. In this session, your speaker will offer tips, tools, and guidance on identifying and selecting clinical sites, and then managing clinical sites throughout the study. Using site relationship management techniques, your instructor will provide insights into improving the performance and relationships with so-called “difficult” sites, and getting those partnerships back on track.

10:35 Case Study: Study Health Checks: A Compilation of Site-Specific Data Used to Assess Site and Study Trends and Potential Risks

Rosanne Petros, PMP, Associate Director, Clinical Research, Clinical Research Manager US Global Clinical Trial Operations, The Americas, Merck Research Laboratories

Although Merck does not currently utilize risk-based monitoring per se, US Clinical Operations is piloting the use of a comprehensive set of reports which are joined and metrics calculations are performed within an Access database. The reports feed data into the database which is manipulated to provide one item per column per study site on a spreadsheet. Multiple reports are needed because the associated raw data is housed in various applications, the datasets are very large, and within the large datasets some data is not joined to other oversight data. Metrics assessed include site status, enrollment metrics, SDV metrics, TMF reconciliation metrics, PI oversight metrics, open action items, protocol deviations, CRA and study coordinator turnover metrics, monitoring visit frequency metrics, and query metrics. Depending on the type and phase of the study (i.e., initiation, enrollment, maintenance, or closeout), the metrics are assessed for risk and outliers.   

11:10 Building Quality by Design (QbD) and Quality Risk Management (QRM) Systems into Clinical Site Operations: An Academic Clinical Research Site Perspective

Marina Malikova, Ph.D., Executive Director, Surgical Translational Research, Operations, Compliance, & Surgery, Boston University

In this competitive global market technology is vastly changing the way the industry conducts clinical trials. The research industry continues to explore how innovative systems and processes can improve quality while reducing cost. The FDA in September of 2013 published guidance on electronic source data in an effort to modernize clinical investigations. However, electronic regulatory binders remain underutilized and represent a cost savings to clinical investigators, CROs, and sponsors. Successfully implementing electronic regulatory binders while maintaining compliance takes expertise from the investigative site, the Clinical Research Associate (CRA), and the Information Technology (IT) team. This presentation will discuss how to design and implement the system with appropriate security measures and the benefits and challenges of using the system.

11:45 Electronic Data Capture: Tablets vs. Desktop. A Sponsor to Site Implementation Perspective

Lynne Becker, MSPH, National Project Manager, Weight Management Center Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina

When you introduce a new medium (tablets) for the electronic data collection, you may open the proverbial Pandora’s Box when it comes time to monitor. There are no standardized regulations across commercial or academic regulatory agencies which govern your research site, nor are the IP access points similar from site to site. Other concerns are the quality of optical character recognition (OCR) and optical character mark recognition (OMR); hurdles to minimize site frustration for not only the coordinator, but the PI and the subjects; and the cost of the tablets. If you are considering implementing the full use of tablet technology you must understand and embrace the loss of paper trail during the monitoring process. This presentation will correlate the current best practices of monitoring a paper-based system with a tablet based system.

12:20 pm Close of Conference

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From the Producers of SCOPE