Clinical Trial Oversight Summit


Barnett International/CHI’s fourth annual Clinical Auditing Forum will feature best practices for risk-based auditing techniques, quality systems-based approaches to auditing, and ensuring GCP inspection readiness. This event will focus on how to strengthen auditing programs, ensure compliance, manage non-compliance, RCA and CAPA, and international auditing techniques. Participants will benefit from real-world examples of risk-based approaches to auditing sites, systems, and providers, as well as insights, case studies, hands-on activities, and take-away tools for clinical auditors.


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Wednesday, June 4, 2014

7:00 am Registration and Morning Coffee

8:00 Barnett Welcome & Chairperson’s Opening Remarks




8:15 Implementing a Risk-Based Auditing Approach in Clinical Trials

Federico Feldstein, J.D., Senior Director, Quality Assurance, Pfizer

Karine Julien, MBA, MSc, Disease Area Lead, Cardiovascular/Metabolic Disease, Pfizer Medical Quality Assurance

Risk-based auditing is intended to help identify key priority programs for audit purposes. The process begins with the active involvement of key stakeholders across an organization to perform risk assessments, leading to the implementation of a risk-based auditing approach to mitigate risk at an enterprise level. It also allows for a greater focus of resources on priority programs, while still maintaining in-depth assessment of patient safety and rights, data quality and study integrity, and compliance with protocols. This presentation will discuss some approaches to the implementation of risk-based auditing activities, critical to success factors and the benefits of the implementation of this process, as well as a case study of the implementation of risk-based auditing at Pfizer for clinical trials.


9:00 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., CCRA, MA, Clinical Investigation, Executive Director, Surgical Translational Research Operations and Compliance, Boston University

At Boston University, we have established Quality by Design (QbD) parameters and Quality Risk Management (QRM). QbD and QRM are a new expectation by regulatory agencies under GCP. In light of RBM and the expansion of QRM, the need for the integration of these two concepts becomes apparent. The premise behind RBM is that monitoring quality can improve by leveraging existing data intelligence. This, in turn, calls for more robust quality assurance (QA) systems focused and efficient resource utilization and allocation at the clinical site level. QRM is the proactive identification and mitigation of risks. By combining these two concepts, the inherent risks identified up front can feed into the design of the RBM plan QbD. This session will demonstrate practical aspects of developing key performance and quality indicators at all stages, and follow-up of the identified signals.

9:45 Coffee Break and Exhibit Viewing



10:15 Risk-Based Approach to Internal Audit Schedule

Ellen Liedel-Sargent, Director Clinical Quality Assurance, ICON , Plc.

Implementing an internal audit schedule can help appropriately assess the risks and utilize resources in the most cost effective manner. Annual audit schedules should address site audits, process audits, project- or program-specific audits, and vendor audits. The audit plan should be based on timely identification of risks or issues that allow mitigation in order to preserve the quality of the data and safeguard the study participants. A systematic process can be accomplished using the EMA approach of risk-based quality management in clinical trials. Specifically:

  • Identification of risks or areas of risk, and understanding their impact
  • Decision making on identification of areas of high risk that may require mitigation or confirmation that potential risks are properly addressed
  • Ongoing effectiveness checks to ensure mitigation is providing desired outcome

11:00 Interactive Roundtable Discussions

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

1:00 pm Utilization of a Risk-Based Compliance Audit Tool for the Conduct of Audits

Ken Schiff, BA, MBA, Quality Risk Management Associates, LLC

The Compliance Audit Tool will assist auditors in conducting audits and ensuring consistency in capturing and reporting audit findings from compliance audits, such as those performed on clinical trial centers. This risk-based auditing tool contains built in risk assessment methodologies which allows audit findings to be classified by risk impact (high, medium and low).In addition to the classification of audit findings, the use of such a tool will allow trending of audit findings across many types of audits. The compliance audit tool has the ability for automated generation of the audit reports and action plan documents which will allow for a much quicker turnaround time for reporting and CAPA management.



1:45 Change at FDA Brings Challenge to Industry

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

Currently FDA is challenging the oversight of clinical investigations with a risk-based approach. This session will include an overview by a former FDA medical officer of the importance of how high quality monitoring/auditing can help ensure sites are prepared for FDA inspections. Utilizing case studies and questions from participants, we will de-mystify the process of FDA audits using this new Guidance to Industry. Upon completion of this program participants will be able to:

  • Ensure investigational study sites are prepared to meet new guidance
  • Understand how key aspects of how the guidance may affect your study plans
  • Understand FDA’s latest approach to risk-based clinical investigations
  • Know what steps you can take to become a futurist thinker on FDA

2:30 Regulatory Trends: Review of Recent FDA 483/Warning Letters Findings for Sponsors, IRBs, and Sites

Paul Papagni, Executive Director, Research, Holy Cross Hospital CHE

FDA findings serve as an excellent training and audit preparedness tool to ensure that you are focusing on relevant risks. Research teams, sponsors, and IRBs can learn from the past mistakes of others and utilize findings as a checklist for future self-audits and training. “We are in this together” the FDA is helping to align and delineate priorities to ensure safe, high quality clinical trials. Is your “risk-based” plan adequate to address unanticipated problems? After this session, participants will be able to:

  • Develop a checklist for compliance based on FDA findings
  • Identify current “hot topics” and trends in research compliance
  • Develop training programs to anticipate FDA Visits and ensure “audit readiness”

3:15 Sponsored Presentation (Opportunity Available)

3:30 Refreshment Break and Exhibit Viewing

3:50 International Audits: Regulatory Requirements, Regional Considerations and Similarities and Differences from FDA

Speaker to be Announced

4:35 Comparing Drug to Device GCPs: ISO 14155 to ICH E6

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

Back in 1996 the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) adopted the ICH E6 guideline in regards Good Clinical Practice (GCP) for drug studies and more recently (2012) FDA’s Center for Devices and Radiological Health (CDRH) recognized the ISO 14155 Standard for GCP conduct within medical device studies. Though there are many similarities between the two, each also has unique characteristics, right down to why FDA can adopt one but only recognize the second. This presentation will outline the purpose of the ICH E6 guideline and the ISO 1455 Standard. Differences and similarities between the two approaches will be discussed.

5:20 Welcome Reception and Exhibit Viewing (Sponsorship Opportunity Available)

5:45 Short Course Registration

6:00 – 8:30 Short Course 4, Take Control of Your RCA and CAPA Activities to Achieve Clinical Excellence (see Short Courses for additional information)

6:20 Close of Day One


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