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Risk-based principles and quality management systems are the new reality of clinical auditing. Building on their foundation of traditional auditing techniques, auditors must now expand and adapt their skills to be effective in this new environment. CHI’s fifth annual Clinical Auditing Forum is designed to help auditors meet these challenges head on, with the goal of strengthening auditing programs and ensuring compliance with risk-based techniques. We invite thought leaders to submit abstracts with real-world insights and examples of risk-based approaches to auditing sites, systems, and providers.

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Tuesday, June 2

12:00 pm Conference Registration

1:15 Welcome & Chairperson’s Opening Remarks


1:20 Implementing Risk-Based Auditing

Dirk Gille, Vice President, Head Bioresearch QA, Janssen R&D, Belgium

To ensure patients in high medical need continue to have access to affordable drugs, companies and authorities are looking at means to decrease the cost of clinical trials while still maintaining oversight on patient safety and integrity, and data credibility. A risk-based approach has been encouraged by both EMA and FDA as a means to deploy resources where it matters most based on identified risks. Auditing is an important tool to get detailed insight in the quality and compliance of clinical development and more specifically the execution of clinical trials. This presentation will provide insight on a proposal on how risk-based auditing can be implemented in an organization by deploying a risk management framework, performing a formal risk assessment on the trial, and translating the identified risks and related controls into the audit diagnostic tool, used by the auditor.

1:55 Risk Management: An ICH Perspective

Bob Figarotta, Senior Manager, Clinical, Allergan

ICH Q9 principles outline quality risk management methodologies that can be applied to all types of audit programs. This includes tools to assist in discovering where audit programs should focus their attention and resources, and what to do with risks identified during the planning and execution of the audit program. This presentation will encompass discussion of the following areas of risk management with an ICH Q9 perspective:

• Potential Applications

• Quality Risk Management Process

• Assessments and Controls

• Facilitation

• Methods and Tools

2:30 Sponsored Presentation (Opportunity Available)

3:00 Networking Refreshment Break and Exhibit Viewing

3:30 Rethinking CAPA Metrics and TMF Metrics: Are You Measuring the Right Things?

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

The Metrics Champion Consortium (MCC) has done extensive research into the standardization of metrics that drive clinical trial quality. In this session, your speaker will address:

• How what you measure influences people’s behavior

• How adopting performance metrics supports clinical trial planning

• How the right metrics can support your QMS knowledge management program

4:05 Building an Effective CAPA Management Process

Federico Feldstein, J.D., Vice President, Medical Regulatory Compliance, Pfizer, Inc.

This presentation will provide an overview on quality issues and the execution of a CAPA, with a focus on building an effective CAPA management process. Topics will include:

• Developing a compliant, effective, and efficient CAPA System

• Conducting a robust, systematic investigation and effectively measuring performance

• Examining quality issues to determine severity, occurrence, and level of impact (systemic vs. non-systemic issues) to prioritize management and remediation

• Addressing systemic issues at multiple sites, executing a CAPA, and overseeing CAPA execution

• Case Study: Reinforce your understanding of CAPA management and execution by applying best practices to manage a systemic quality issue

4:40 Risk-Based Monitoring and Quality Management Systems

Denise M. Shelley, MS, Clinical Project Manager II, Clinical Monitoring Research Program, Frederick National Laboratory for Cancer Research

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

5:45 Short Course Registration

6:00 Close of Day One

6:00 - 8:30 pm DINNER SHORT COURSE:
(SC2) Quality by Design in Clinical Research: Is This Only for the Protocol?* 

*Separate registration is required. 

Wednesday, June 3 

7:15 am Breakfast Presentation (Sponsorship Opportunity Available)
or Morning Coffee

8:00 Chairperson’s Opening Remarks

8:10 Avoiding the Leap from 483 to Warning Letter

Robert Romanchuk, Principal, Schulman Associates, IRB

All too often, sites move on after responding to a 483 only to receive a Warning Letter a few months later. A series of sponsor, IRB, and FDA audits ensue, with business consequences that can be tragic. In worst case scenarios, a good site is taken down simply because they did not respond to a 483 adequately. (Un)fortunately, the records of these events are public and can be consulted by those wishing to avoid this chain of events. This presentation will analyze recent 483s and Warning Letters, examine guidance, and extrapolate best practices to avoid the leap from 483 to WL. Your presenter will share practical experiences from his nine years of investigator site audits on behalf of independent IRBs.


8:45 Quality Assurance/Control and Quality Assessment Measures in Human Subject Research

Jeanne M. Mattern, Ph.D., Director, QHS Regulatory Compliance Office, Section Head QHS Clinical Research Informatics, Business Intelligence/OHCD Compliance, Cleveland Clinic

Quality assurance/quality control measures are activities undertaken in order to demonstrate accuracy and precision and a plan to maintain quality in all aspects of a research program. This plan should include steps such as monitoring, proper documentation of procedures, training of those conducting the QA/QC in how to review quality of study design, data management and analysis. This session will discuss the benefits, best practices, and lessons learned from conducting face-to-face quality reviews and the steps taken to determine the quality of a project and assessment of the overall procedures and accuracy and safeguarding of project data during a project and at the end of a project during analysis and publication phases.

9:20 Sponsored Presentation (Opportunity Available)

9:35 Networking Coffee Break and Exhibit Viewing

10:20 Achieving Compliance in Human Subject Research: Elements of Compliance Structures and Quality Systems

Johanna L. Stamates, RN, MA, CCRC, CHRC, Executive Director, RCQA (Research Compliance and Quality Assurance), University of Miami

The field of clinical research is constantly evolving. The ever-changing regulations, rules and guidance documents, increased oversight by regulatory agencies, and the increasing sophistication of the public and of potential research subjects require not only sponsors, but also universities and academic medical centers to stop and reflect on their current practices in the conduct of clinical research. The current climate requires awareness, implementation of a robust compliance structure, use of quality systems, and risk management approaches. In short, a proactive rather than a reactive approach. This presentation will provide the audience with examples of positive changes, heightened awareness, and strategies for the implementation of new and strengthening of existing compliance structures and quality systems. Essential elements for a robust organizational compliance structure and examples of potential/existing barriers in the compliance “culture” will be presented. Attendees will be introduced to existing quality systems at the University as well as those in the planning and implementation stage. The take-home message is that compliance professionals must be viewed as change agents rather than clinical research police.

11:00 Interactive Roundtable Discussions

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


1:00 pm Sponsor Oversight: The Importance of Auditing in Vendor Management

Beverly Brown, Manager, Global Regulatory Quality, Allergan

1:35 Risk-Based Audit Planning: Developing a Three Year Strategy

Rita Farrell, Compliance Specialist, Global Quality & Regulatory Compliance – Clinical Trials & Safety (GQRC-CT&S), Bristo-Myers Squibb

This session will address the strategy and risk management techniques applied to planning Good Clinical Practice (GCP) audits from both a short and long term perspective. The presentation will include a review of the planning for three audit types: investigator site audits, vendor audits, and internal system audits (including safety related audits). In addition, it will outline the process of obtaining stakeholder input and management endorsement, including the guidelines utilized to obtain data, calculations used to analyze the data, and the resulting documentation.

2:10 Sponsored Presentation (Opportunity Available)

2:25 Networking Refreshment Break

2:40 Randomized Controlled Trials: Ethics, Consenting, Maintaining the Blind, and Protocol Adherence

Jerri B. Perkins, M.D., former Medical Officer, FDA

Currently (NEJM Dec 18, 2014) FDA is making the case for RCTs (Randomized Controlled Trials) in evaluating Ebola therapies. FDA is challenging industry and the medical community in the necessity of conducting scientifically valid trials and understanding the importance of the placebo effect. This session will include an overview by a former FDA medical officer on the importance of learning how to think like a regulator especially during the consenting process, maintaining the blind and protocol adherence. This presentation will use case studies to demonstrate the power of RCTs to achieve success. Bring your questions and join the discussion as we learn to see through the eyes of a regulator. Upon completion of this program participants will be able to better prepare investigators and site for current study design challenges to fulfill both ethical and regulatory requirements.

3:15 Managing Global Inspections

Janis A. Little, MS, Vice President, Global Regulatory Quality, Allergan

3:50 pm Close of Summit

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