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2013 Archived Content

Third Annual | June 5-6, 2013
Clinical Auditing Forum

Ensuring Audit Readiness and GCP Compliance Across Clinical Research Functions

The third annual Clinical Auditing Forum, focuses exclusively on regulatory agencies’ changing focus and expanding expectations regarding GCP compliance. Thought leaders will relate their experiences ensuring clinical research compliance through strategic approaches to clinical quality assurance and on “GCP Inspection Readiness,” with a focus on developing and strengthening auditing programs. Auditing techniques for ensuring compliance, managing non-compliance, root cause analysis and preventive and corrective actions will be a focus throughout. Sessions will address preparing sites for regulatory inspections, including techniques for sites related to billing compliance, self-monitoring and quality management. Real-world examples of risk-based approaches to auditing sites, systems and providers will be featured, and FDA and international regulatory agency expectations and recent inspection trends will be discussed. Attendees can expect case studies, hands-on activities, take-away tools, breakout groups and interactivity.

Day 1 | Day 2 | Download Brochure 

Wednesday, June 5, 2013

7:00am Registration and Morning Coffee

8:00 Barnett Welcome & Chairperson’s Opening Remarks



8:15 Quality Systems: The RSQA Model at the University of Miami

Johanna L. Stamates, RN, MA, CCRC, CHRC, Executive Director, Regulatory Support and Quality Assurance, University of Miami

Starting in 2011, the Office of Regulatory Support and Quality Assurance (RSQA) residing within the Office of Research, Miller School of Medicine at the University of Miami advanced from a well established auditing program into a quality improvement program to provide support and assistance to the university research community. In 2013, RSQA will implement a university wide CAPA system as well as regulatory support for university researchers to assist with compliance. Quality management approaches as well as risk management principles are applied throughout the entire process of implementation. This presentation will provide the audience with our experience in transitioning from an auditing to a quality systems approach, and demonstrate how auditing and monitoring can work in a symbiotic relationship to benefit the university’s research mission.

9:00 SOP Assessment: Ensuring GCP Compliance in Standard Operating Procedures (SOPs)

Elizabeth Ronk Nelson, MPH, President and Senior Consultant, Regulatory Risk Management

Standard Operating Procedures (SOPs) are defined as detailed, written instructions that permit processes to be executed uniformly. In an effort to ensure compliance with regulations and guidelines, many sponsors, CROs, and clinical research sites have developed and incorporated SOPs into their operations. Although training of staff and assessment of comprehension and compliance are crucial to implementation, the content and structure of SOPs should be routinely audited to take full advantage of their purpose. The session will introduce regulatory expectations for SOPs and some approaches to evaluating SOPs to ensure they are current and compliant. Session objectives include:

  • Discuss the FDA’s expectations for Sponsor/CRO, IRB, and Clinical Investigator SOPs
  • Examine the systems for compliant development, implementation, and management

9:45 Networking Coffee Break and Exhibit Viewing

10:15 Creating a Quality Systems-Based Approach to Clinical Trial Auditing that Produces Reliable Data

Bradley Wong, Consultant to Allergan

11:00 Interactive Roundtable Discussions

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


1:00pm Investigator Responsibilities: A Real-Life Compliance Issue, and Corrective Action

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

This session will review current device GCP trends for principal investigators and identify common device GCP risks for Investigator/Sponsor Studies. The session will explore investigator issues of device GCP non-compliance among Academic Health Centers (AHCs) and will examine an AHC device case study and corrective action.


1:45 Enhancing Auditor Emotional Intelligence

Tabitha K. Westbrook, RQAP-GCP, Manager, Quality Assurance, INC Research, former Head of Quality Assurance, Central IRB

Audits are often viewed as transactional and factual – and rightly so! They are transactional (a process carried out) and must be factual, devoid of as much personal bias and emotion as possible, presenting only facts to the auditee(s).  However, the power of advanced soft skills in enhancing the both the transactional and factual aspects of an audit cannot be underestimated.  We have all heard stories of auditors who possessed little to no soft skills – and those audits were likely rather painful. The use of appropriate, advanced soft skills also serves to reinforce a culture of quality with the auditee, which is something that most senior management teams today are trying to achieve. The most important soft skill a quality professional can possess is his/her emotional intelligence. In this session, attendees will receive detailed information regarding auditor emotional intelligence, including practical skills that attendees can use to enhance their emotional intelligence and encourage emotional intelligence in others. Real case scenarios will be provided to help illustrate this concept. By the end of the session, attendees will have the information and practical application needed to understand and enhance emotional intelligence.  Participants will understand how the use of such a skill reinforces a culture of quality within and outside organizations.  Further, attendees also will be able to carry this information into personal interactions, thereby enhancing their personal as well as professional lives.

2:30 Defining “GCP Inspection Readiness” in Today’s Regulatory Environment

Treena Jackson, MS, CQA, RAC, CSSGB, Quality Resource Consulting, Inc.

The session will provide information regarding what “inspection readiness” means as pertinent to the FDA Investigator Site and Sponsor-Monitor Inspections. In the present regulatory environment with heightened regulatory surveillance, it is essential to understand the FDA inspection process and be prepared for a regulatory inspection at all times. The audience will gain knowledge regarding the following:

  • Information pertinent to the FDA Investigator Site and Sponsor-Monitor Inspection processes such as selection, conduct, and communication of the inspectional findings
  • Preparation activities such as planning meetings to discuss the inspection logistics, roles, and responsibilities
  • Ongoing documentation preparedness
  • Preparation of standard procedures to address inspection activities such as greeting the FDA investigator(s), inspection room activities, responding to the FDA requests, inspection feedback, and conclusion

3:15 Sponsored Presentation (Opportunity Available)

3:30 Networking Refreshment Break and Exhibit Viewing


3:50 Case Study Discussion with a former FDA Medical Officer: What the FDA Looks for at Your Site (Session 1 of 2)

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

Warning letters vividly describe errors made, identified by FDA inspectors and classified as deserving attention. Knowing how FDA sees your site and your data helps sponsors, sites, investigators, monitors, and all involved in clinical studies prepare for an FDA inspector. Let this former FDA medical officer share examples of clinical nightmares and errors in Good Clinical Practices (GCPs) that could have been avoided. This discussion with the opportunity of interactive questions and answers will offer practical examples on ways to meet GCPs. Topics addressed include:

  • Why Does FDA audit?
  • What Does FDA find?
  • How can sites and investigators avoid costly errors?

4:35 Warning Letter Discussion with a former FDA Medical Officer: How to Avoid Warning Letters and What Can Be Learned from Them (Session 2 of 2)

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

Warning letters vividly describe errors made, identified by FDA inspectors and classified as deserving attention. Knowing how FDA determines when and if to issue these letters will help sponsors, sites investigators, monitors, and all involved in clinical studies better prepare for an FDA inspector and respond to investigator questions. Let this former FDA medical officer share a training example of a clinical nightmare and errors in Good Clinical Practices (GCPs) that could have been avoided. This discussion with offer the opportunity of interactive questions and answers and practical examples on ways to meet GCPs.

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

5:45 Short Course Registration

6:00 - 8:30 Dinner Short Course 2, Quality-Systems Based Approaches to a GCP Auditing Program 

6:20 Close of Day One

Day 1 | Day 2 | Download Brochure