Presentations

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Click Here for the 2012 Annual Conference Schedule-At-A-Glance.

Presentations by Track:

• Track 1
• Track 2
• Track 3
• Track 4
• Track 5 (Friday)
• Track 5 (Saturday)
• Track 6
• Track 7
• Track 8

Presentations by Date:

Friday, September 21, 2012

Saturday, September 22, 2012

Sunday, September 23, 2012

Friday
September 21, 2012

Opening Plenary Descriptions

Fri., Sept. 21- Opening Plenary- 8:30 to 9:15
Welcome and Introduction
Jason Jones, BS, MS, CCRP, President – SoCRA
Daniel Redline, BA, CCRP, President Elect - SoCRA - Annual Conference Chair
The speakers will describe issues related to the practice of clinical research in the current regulatory environment and how SoCRA works to promote education and training within the clinical research community. 101

Fri., Sept. 21- Opening Plenary- 9:15 to 10:00
The Total Product Lifecycle Concept
Michael Marcarelli, PharmD, MS, Director, IDE & HDE Programs, Food & Drug Administration
Dr. Marcarelli will discuss regulatory topics on drug and device development using FDA’s Total Product Lifecycle concept. 103

Fri., Sept. 21- Opening Plenary- 10:45 to 11:30
Current Concerns Regarding Research Protections - Domestic and Global
Gary Chadwick, PharmD, MPH, CIP, Professor, University of Rochester
Research involving human subjects is and has been an evolving field. While federal and international regulations and ethics codes have been fairly stable for the past 20 years, the regulatory expectations for compliance and documentation have changed -- usually becoming more stringent. Dr. Chadwick will focus on areas that present the greatest challenges for researchers and regulators domestically and globally. 105

Fri., Sept. 21- Opening Plenary- 11:30 to 12:15
The “+1” Patient: Social Media and Our Disease Experiences
Leslie Hammersmith, MA, eLearning Analyst, University of Illinois at Urbana-Champaign
Ms. Hammersmith will discuss how gaining knowledge through authentic scientific discussion among professionals enhances the credibility of our patient advocates and educates them faster and better than classroom learning alone. This knowledge may give them the confidence in their work that helps treatment centers and research organizations continue to improve protocols, dissemination, and participation in research that will help us come closer to more effective prevention, treatments and cures. Generational expectations, cultural differences, and professional norms tend to come through loudly and clearly especially when social media plays a role in the diagnosis, treatment and survivorship experiences of the patient. Through likes, tweets, tagging, and sharing, the “+1” patient connects social experiences to become engaged in the science of accelerating progress against disease. 107

Track 1 - Device Research

Fri., Sept. 21- Device Research- 1:30 to 2:15
Overview of IVD Trials
Marieann Brill, MBA, RAC(US), MT(ASCP)
Senior Regulatory Affairs Scientist
Clinical Research Management
In Vitro Diagnostics is a rapidly advancing field and we face many challenging in the development of new technology and conducting research with these new products and technology. This session will discuss some of the challenges with conducting research with IVDs. Topics include proof of concept, design IVD trials, startup and site selection, and monitoring for US and international studies. 109

Fri., Sept. 21- Device Research- 2:20 to 3:05
Device TPLC (Total Product Life Cycle) Overview
Michael Marcarelli, PharmD, MS
Director, IDE & HDE Programs, Food & Drug Administration
Donna Headlee, RN, BSN, CCRP
The contents of this presentation are my own, and do not necessarily reflect the views and/or policies of the FDA or its staff. The FDA will not be bound by any of the comments in this presentation.
This will be an interactive session discussing aspects of medical device total product life cycle. Topics will include IDEs, PMAs, GCP and compliance strategies. 111

Fri., Sept. 21- Device Research- 3:35 to 4:20
Pharma vs Device Research: Examining the Differences
Susan Rawn, BSN, CCRP, RN
Clinical Research Coordinator, University of Tennessee
How do these types of research differ? We will look at items like FDA requirements, IND vs IDE, price differences, SAE reporting differences, etc. 113

Fri., Sept. 21- Device Research- 4:25 to 5:10
CDRH BIMO Inspections: Lessons Learned
James Saviola, OD, Director, Division of Bioresearch Monitoring, Center for Devices and Radiological Health, U.S. Food and Drug Administration
This session will discuss common regulatory pitfalls found during FDA CDRH BIMO inspections and expound on nuances of regulatory violations observed. Lessons learned and strategies for the conduct of a quality trial will also be discussed. 115

Track 2 - International Research

Fri., Sept. 21- International Research- 1:30 to 2:15
Going Global with Clinical Trials
Ginger Autry, BSN, RN, CCRP
Senior Clinical Research Associate, Abbott Vascular
Over 40% of all US-regulated clinical trials are now conducted overseas. Within the next two to three years, up to 65% of FDA-regulated clinical trials will be conducted abroad. This presentation will cover the trend of sponsors going global to conduct clinical trials as well as the challenges and lessons learned from a sponsor perspective. Discussion will consist of examples from Europe, Latin America, and Canada, including specifics regarding Competent Authority submissions in these countries. 209

Fri., Sept. 21- International Research- 2:20 to 3:05
The Revision of the EU Directive 2001/20/EC - Where We Are and What Is Newly to Be Considered- A Critical Review
Gerhard Fortwengel, PhD, MPH, Professor, University of Applied Sciences and Arts, Hannover, Germany
On 9 February 2011, a public consultation on a concept paper on the revision of the ‘Clinical Trials Directive’ 2001/20/EC was launched. The concept paper presents: a ‘preliminary appraisal’ of which option appears to be the most suitable one to address some of the key concerns of the Clinical Trials Directive, on the basis of the current state of the impact assessment; and the main figures that are being used to evaluate the impacts of the different policy options. The presentation will discuss the status of the revision in summer 2012 and will particularly focus on changes implemented and how they must be applied when conducting clinical trials in one of the EU-member states. 211

Fri., Sept. 21- International Research- 3:35 to 4:20
Clinical Trials in the European Union: Legislative Framework
Anatoly Gorkun, MD, PhD, Senior Manager, Training and Standards, MedImmune, United Kingdom
Currently, there are 27 Member States in the European Union. If you have to run a trial in the area, a number of questions may arise: What is the EU Clinical Trial legislation framework and the role of EU Directives? How does one prepare a Clinical Trial Application? What is the purpose of Eudra CT database? This session will cover these questions and explain how country-specific legislation is created, using the UK as an example. 213

Fri., Sept. 21- International Research - 4:25 to 5:10
Directive 2010/84/EU: The EU Pharmacovigilance Directive - What Has Been Changed and Can the Directive Help to Better Protect and Inform Patients About Their Drugs and any Associated Risks
Gerhard Fortwengel, PhD, MPH, Professor, University of Applied Sciences and Arts, Hannover, Germany
Tessa Freiholz, BA, Student, University of Applied Sciences and Arts, Hannover, Germany
The new EU-Directive, which came into force in December 2010, follows the risk approach and details how patient safety should be ensured in the future. As part of a research project at the University of Applied Sciences and Arts in Hannover, conducted during the winter term 2011, any new requirements and innovative changes will be identified and their implications on current pharmacovigilance routine activities will be investigated. In particular, the document will be critically analyzed and discussed concerning consequences arising from changes for the user, the patient. The session will include a brief overview of the Directive and the results of the research project will be presented. 215

Track 3 - Complementary & Alternative Medicine

Fri., Sept. 21- Complementary and Alternative Medicine- 1:30 to 2:15
Complementary and Alternative Medicine in Cancer Treatment: Meeting Regulatory and Clinical Needs
Arun Kurup, BS, Oncology Student Pharmacist
University of Minnesota / College of Pharmacy
CAM is used extensively for general health and are gaining more attention in cancer treatment. To ensure that CAM is evaluated critically, we discuss regulatory considerations that, if proactively addressed, help CAM studies impact the future of cancer therapy. 309

Fri., Sept. 21- Complementary and Alternative Medicine- 2:20 to 3:05
CAM - Integrative Medicine: What Is It, Who Uses It, and Why Is It Important to Research?
Handout
Nancy Wintering, BA, MSW, LCSW, CRC, CCRP Research Program Manager, Thomas Jefferson University
Complementary and Alternative Medicine (CAM) or Integrative Medicine can utilize conventional western medicine approaches together with CAM - not as a parallel or alternative to effective treatment or health management. CAM is widely used but is often not reported to medical professionals. This session will define CAM, identify the integrative medicine practitioners involved, how they are trained and what they practice, as well as explain how CAM can be applied in a clinical research setting. Challenges faced in research that utilizes CAM include: measuring effectiveness, study design considerations, identifying and managing risks, and developing approaches to collaborative partnerships with patients and CAM practitioners to ensure human subject protection. 311

Fri., Sept. 21- Complementary and Alternative Medicine- 3:35 to 4:20
Genes in Your Food Help Determine Your Genes and Your Health
Charles Muscoplat, PhD
Professor of Medicine and Food Science and Nutrition; Dean Emeritus, University of Minnesota
Health outcomes can be greatly influenced by food and nutrition. However, much more is due to the interactions of food components and chemicals with the genome of the person eating a particular food. The speaker will show dozens of examples of food constituents epigenetically altering the human genome and producing long term or generational health effects. The opportunity and strategy for drug development or medical foods are discussed. 313

Fri., Sept. 21- Complementary and Alternative Medicine- 4:25 to 5:10
Comparative Effectiveness Methods in Respiratory Research
Melissa Roberts, MS
Senior Research Associate, LCF Research
Obstructive lung disease is an area in which there have been numerous studies on the comparative effectiveness of pharmaceutical and non-pharmaceutical treatment therapies. Methods of comparative effectiveness analysis have been evolving over the past decade, with wider use of simulation models in recent years. Comparative effectiveness methods that have been used in obstructive lung disease research will be discussed, including strengths and weaknesses and ease of understanding the implication of findings in clinical practice. 315

Track 4 - Audit

Fri., Sept. 21- Audit- 1:30 to 2:15
FDA Audits: A Few Good Things to Know
Aimee Edwin, MD, Bioresearch Monitoring Consultant
J&J Audit and Consulting, Inc
This talk will help to prepare participants for clinical trial audits by FDA. It will provide background information on FDA procedure/policy, a description of typical areas covered during an audit, and tips on handling situations that could arise during an inspection. 409

Fri., Sept. 21- Audit- 2:20 to 3:05
An Internal Quality Control Program: To Be or Not To Be
Linda Knowlton, AA, CCRP, Assistant Project Manager/Lead CRA Auditor, Coalition of Cancer Cooperative Groups
Ms. Knowlton will review the CTMB Audit Guidelines. In addition, she will review how you can develop an internal quality control program based on the CTMB Audit Guidelines. She will provide auditing tips to the attendees as well. 411

Track 4 - Advanced Management

Fri., Sept. 21- Advanced Management- 3:35 to 4:20
Internal Auditing of a Clinical Trial
Valerie Cronin, BA(Hons), MA, CCRP, RN, SCM
Clinical Research Nurse Coordinator, Ottawa Hospital Research Institute
A summary of the key audit components and findings from an internal audit at our clinical trial site will be presented. Lessons learned from the audit experience, opportunities for improvement, and implications for future clinical trial management will be illustrated. A brief overview of the pertinent regulations and guidelines from Health Canada (Division 5) and the Tri-Council Policy Statement II will be highlighted in the context of a clinical trial audit. 413

Fri., Sept. 21- Advanced Management- 4:25 to 5:10
Determining Whether Human Research Can Be Conducted Without an IND
Harvey Arbit, PharmD, MBA, CCRP, RAC
President, Arbit Consulting, LLC
FDA issued a draft guidance document on this topic in October 2010. This presentation will discuss the important points of the decision making process as suggested by FDA. It will also discuss the process for seeking advice from the FDA regarding the application of the IND regulations. Examples and background will be provided. 415

Track 5 - Site Management

Fri., Sept. 21- Site Management- 1:30 to 2:15
Minimal Risk: What Is it All About?
Tammy Neseth, BS, CCRP, Coordinator, Research Operations, Mayo Clinic Cancer Center
During this session Ms. Neseth will compare and contrast minimal risk and greater than minimal risk research. 509

Fri., Sept. 21- Site Management- 2:20 to 3:05
Site Management Challenges: A Barrier to Good Clinical Trial Conduct
Maribelle Guloy, BS, CCRP
Site Director, Clinical Trials and Research Associates, Inc.
The challenges encountered in trial management include logistical, accountability, and performance issues. These challenges negatively impact clinical trial conduct and run contrary to good clinical practice. If these issues are not appropriately addressed, the sponsor may exercise the discretion to terminate the study which can be costly for the clinical trial center. 511

Fri., Sept. 21- Site Management- 3:35 to 4:20
Challenges of a Small Site
Marci Dassinger, CCRP, Research Administrator Cardiology Consultants of East Michigan
Small, private practice sites experience challenges that are more difficult to overcome than at larger institutions. Research teams at private practices are rarely confined to only conducting research, but instead multitask between multiple positions. Therefore, research may not be embraced fully by management and resources are more limited at smaller sites. This session will address these issues and suggest solutions, as well as ask for feedback from the audience. 513

Fri., Sept. 21- Site Management- 4:25 to 5:10
The Auditor Is Your Friend
Lauren Kelley, BA, CCRP, GCP Auditor, Polaris Compliance Consultants Inc.
It’s time to view the auditor as a friendly colleague who can help you be the best site you can be. This lecture will cover topics such as:

• What should you prepare in advance of an audit?
• What documents does the auditor look for and why?
• What is the best way to answer questions?
• Should you mention that problem you had?

Knowing what to expect and how to prepare will leave you that much closer to a successful audit. The auditor is really there to help. 515

Track 6 - Electronic Data Capture as seen by the Provider, Sponsor, IRB and Investigator

Fri., Sept. 21- Electronic Data Capture- 1:30 to 2:15
Provider View: Electronic Data Capture in Clinical Trials - The Risks, Challenges, and Benefits
Patricia Beers Block, BS, CCRP, Adjunct Assistant Professor, University of Medicine and Dentistry of New Jersey
Electronic data capture in clinical trials offers many benefits. But there are risks and challenges about which we need to be aware. This session will highlight the risks, benefits, and challenges with using EDC for clinical trials, from a technology provider’s perspective. 609

Fri., Sept. 21- Electronic Data Capture- 2:20 to 3:05
Sponsor View: Electronic Data Capture in Clinical Trials - The Risks, Challenges, and Benefits
Joanne Malia, BS, MS, Associate Director, Medical Research Process Management, Purdue Pharma, L.P.
Electronic data capture in clinical trials offers many benefits. But there are risks and challenges about which we need to be aware. This session will highlight the risks, benefits, and challenges with using EDC for clinical trials, from a pharmaceutical/sponsor’s perspective. 611

Fri., Sept. 21- Electronic Data Capture- 3:35 to 4:20
IRB View: Electronic Data Capture in Clinical Trials - The Risks, Challenges, and Benefits
Felix Khin-Maung-Gyi, PharmD, MBA, CIP, RAC
CEO, Chesapeake Research Review, Inc.
Electronic data capture in clinical trials offers many benefits. But there are risks and challenges about which we need to be aware. This session will highlight the risks, benefits, and challenges with using EDC for clinical trials, from an Institutional Review Board’s perspective. 613

Fri., Sept. 21- Electronic Data Capture- 4:25 to 5:10
Investigator View: Electronic Data Capture in Clinical Trials - The Risks, Challenges, and Benefits
Nelson Kopyt, DO, FASN, FACP, CIP
Director of Research, Northeast Clinical Research Center, Valley Kidney Specialists
Electronic data capture in clinical trials offers many benefits. But there are risks and challenges about which we need to be aware. This session will highlight the risks, benefits, and challenges with using EDC for clinical trials, from a clinical investigator’s perspective. 615

Track 7 - Translational Research

Fri., Sept. 21- Translational Research- 1:30 to 2:15
Understanding and Conducting Phase 3 Translation (T3) Research
Julie Bromberg, MPH, CCRP
Clinical Research Coordinator, Rhode Island Hospital
Phase 3 translation (T3) research attempts to move evidence-based guidelines into health practice, through delivery, dissemination, and diffusion research. Research and policy support the integration of adolescent alcohol screening, brief intervention, referral to treatment (SBIRT) services within pediatric level one trauma centers. Using a case study of an ongoing CDC study which examines changes in adoption, implementation and maintenance of SBIRT services in a nationwide sample of seven pediatric level 1 trauma centers, this presentation will describe aspects of the T3 research measured, and then briefly describe SBIRT and the ongoing study. 709

Fri., Sept. 21- Translational Research- 2:20 to 3:05
Biospecimen Management
Anne Eisenhauer, MSc, Manager, Correlative Studies Program, University Health Network/Princess Margaret Hospital
Translational research has become an integral part of clinical research protocols. This session will review types of biospecimens collected for clinical research, the importance of biomarker research, and best practices for high integrity biospecimens. 711

Track 7 - Oncology Research

Fri., Sept. 21- Oncology Research- 3:35 to 4:20
Improving the Efficiency of Oncology Clinical Trial Development in the National Cancer Institute Clinical Trials Cooperative Group Program
Meg Mooney, MD, MBA, Chief, Clinical Investigations Branch, National Cancer Institute
Dr. Mooney will focus on describing how the NCI is implementing new efficiencies into the development of clinical trials for new cancer treatments. This includes a description of how the NCI is supporting Cooperative Groups to meet study activation goals and timelines as well as a description of NCI initiatives to streamline industry – Cooperative Group collaboration. 713

Fri., Sept. 21- Oncology Research- 4:25 to 5:10
Role of the Data Safety Monitoring Board in a Comprehensive Cancer Center
Mira Shah, CIM, CCRP, Manager, Human Research Regulations, UT MD Anderson Cancer Center
Ms. Shah will discuss how a Comprehensive Cancer Center Data Safety Monitoring Board reviews clinical trials that are randomized and blinded. The management of meetings and communication with the IRB will also be presented. 715

Track 8 - Finance and Billing

Fri., Sept. 21- Finance and Billing- 1:30 to 2:15
Medicare Clinical Trial Billing Policy - Where Are You Today?
Kelly Willenberg, MBA, BSN, CHC, CHRC
President, Synergism LLC
The Medicare Clinical Trial Billing Policy is extremely complex! You and your institution should have this on the priority list for overall compliance in clinical trial research. This session will help you understand the rules and regulations you must be following in order to meet the compliance control in billing and practice. 809

Fri., Sept. 21- Finance and Billing- 2:20 to 3:05
Best Practices to Comply with Medicare Clinical Trial Billing Policy
Cheryl Chanaud, PhD, CCRP, System Executive Director of Research, Memorial Hermann Healthcare System
This presentation is complementary to the previous presentation and will describe practices and processes to help ensure compliance with Medicare Clinical Trial Billing Policy. Topics will include review of protocol, comparison of study to Medicare requirements, identification of research procedures and budget, billing practices, and quality control of billing. 811

Fri., Sept. 21- Finance and Billing- 3:35 to 4:20
Variable Billing vs. Fixed-Price Models - How Does Your Clinical Trial Stand to Gain?
David Levin, Vice President, Clinipace
Mr. Levin will examine some of the drivers that are pushing aside traditional ways of billing, including:
• The recognition that hourly billing is excessive in difficult economic times
• A gnawing feeling that clients are poorly served by hourly billing and the bidding practices that it engenders
• A shift toward building strategic relationships between sites, CROs, and sponsors
• The desire to mitigate risk and contain budget
• Adoption of integrated technology platforms 813

Fri., Sept. 21- Finance and Billing- 4:25 to 5:10
Clinical Trial Budgeting for Sites
Dawn Kuzma, Marketing Director, MACRO Group Inc.
Mr. Snyder will provide the participants with an understanding of the trial budgeting process and real tools to enhance their budget assessment and negotiation techniques. The session will begin with a discussion of the trial budgeting environment and methods for sites to operate within the latest regulations. The session will end by sharing real world budgeting examples and a demonstration of the latest budget development processes. 815

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Saturday
September 22, 2012
Breakout Sessions

Track 1 - Device Research

Sat., Sept. 22- Device Research- 8:30 to 9:15
Using ISO 14155 to Guide Compliance for Device Trials
Joy Frestedt, PhD, CCTI, RAC, FRAPS
President and CEO, Frestedt Incorporated
Dr. Frestedt will describe how to use the ISO 14155:2011 to guide research work. She will also list clinical trial steps recommended for a device trial in the EU and explain key requirements of ISO 14155:2011 when conducting medical device clinical trials in the EU. 117

Sat., Sept. 22- Device Research- 9:20 to 10:05
European Regulations for Medical Device Trials
Joris Bannenberg, MD, PhD
Medical Director/COO, Factory - CRO for Medical Devices
Dr. Bannenberg will present an overview of the European regulations for performing medical device trials. The similarities and differences between the different European countries and comparison to FDA regulations will be discussed. 119

Sat., Sept. 22- Device Research- 10:50 to 11:35
In Vitro Diagnostic Trials: The Importance of the Sponsor/CRO Relationship
Dayna Geralts, BS, CCRP
Manager, Clinical Affairs, Hologic Inc
Dan Cormican, BS
Senior Project Manager, Health Decisions
IVD trials have unique challenges that are not always apparent to the CRO community. In return, IVD sponsors are not as familiar with clinical trial sites as other medical device and pharmaceutical sponsors. It is critical that the sponsor and CRO collaborate and educate each other on clinical trial best practices as they relate to IVD studies. 121

Sat., Sept. 22- Device Research- 11:40 to 12:25
Special Considerations for Device Monitoring
Rebecca Rudenko, COT, Senior CRA
D-Target, a Premier Research Company
There are special considerations that must be taken in medical device monitoring. To ensure scientific integrity of a medical device study, in addition to the safety of the subjects and progression of the investigation, the following should be considered: US device-specific regulations, including 21 CFR 812, 50, 54, and 56; items unique to device trials like device accountability, storage of devices, device malfunctions, and procedural information (equipment, intra-operative data); and device-related effects (ADE, SADE, UADE). 123

Sat., Sept. 22- Device Research- 1:40 to 2:25
Device Development: From University to Venture Capital, Lessons from the Process of Invention
Arthur Wallace, MD, PhD, Attending Anesthesiologist and Professor, University of California San Francisco
Device development begins with an idea. Many of these ideas sit in universities and are never developed. Dr. Wallace will discuss how a device navigates the many hurdles to become an FDA approved medical device. 125

Sat., Sept. 22- Device Research- 2:30 to 3:15
Update on Human Factors Engineering for Medical Devices
Edmond Israelski, PhD, CHFP
Director, Human Factors, Abbott
Dr. Israelski will provide an overview of human factors engineering (HFE) for medical devices. He will address the current regulations, newly revised FDA guidances, updates to HFE standards from AAMI, IEC and ISO. 127

Sat., Sept. 22- Device Research- 3:45 to 4:30
Conducting Research to Support Device Development
Stephen Wilcox, PhD, FIDSA, Principal, Design Science
The research methods for optimizing the usability and safety of The research methods for optimizing the usability and safety of medical devices are different from those typically used in other areas clinical research. They involve careful observation to determine current procedures and use environments, application of technical information, and usability testing of prototypes and early production devices. Dr. Wilcox will describe these methods, emphasizing how validity is achieved and how the results are reported. 129

Sat., Sept. 22- Device Research- 4:35 to 5:20
The Challenges in Medical Device Research and the Role of Remote Monitoring in Cardiac Device Studies
Leslie Hale, CT
Arrhythmia & Cardiac Device Specialist, Cardiovascular Research Department, Vanderbilt University Medical Center
An overview of some of the challenges in cardiac device research and the role of remote device monitoring in research (using specific study examples) will be presented. 131

Track 2 - Canadian Regulatory

Sat., Sept. 22- Canadian Regulatory- 8:30 to 9:15
Canadian Drug Clinical Trial Requirements
Candice Hilder, BSc, Manager, Good Clinical Practices Compliance Unit, Health Canada
Ms. Hilder will present an overview of Canadian regulatory requirements pertaining to drug clinical trials, as well as a brief overview of Health Canada’s clinical trial inspection program, and program updates. 217

Sat., Sept. 22- Canadian Regulatory- 9:20 to 10:05
Relationship-Based Selection of Investigators and Partners in Your Clinical Development Program
Robert Huizinga, MSc, RN, CNeph(C)
Vice President, Clinical Affairs, Isotechnika Pharma Inc
In the new global economic market, the pressure is there to bring your clinical development program to a successful end with less time and less money. Should we let price dictate how we run trials, or is there a potential way of keeping costs in line with expectations while maintaining quality? 219

Sat., Sept. 22- Canadian Regulatory- 10:50 to 11:35
Budgeting from a Site’s Perspective
Sharon Appelman-Eszczuk, BScN, RN, CCRP
Director of Operations, University of Alberta GILDR Group
This presentation will describe appropriate tools required to plan for the site budget. Tips for negotiating a successful site budget will be discussed as well as successful implementation of a site contracted budget once the study starts. 221

Sat., Sept. 22- Canadian Regulatory- 11:40 to 12:25
Playing with a Full Deck -- One Coordinator, Eight Studies - How to Make it Work
Gina Vincelli, RN
Study Coordinator/Nurse, Medi Recherche Inc
How can one person do it all? It is not only possible, it is easy. Organization and keeping priorities in order is the key! Using 30 years experience in management and emergency nursing, we were able to triple the number of research patients at our site. We have become the #1 site in Canada (#14 out of 824 worldwide sites) in one of our studies, and we continue to increase our numbers. Effective communication and cooperation with your PI is invaluable. Keeping focused, keeping your sanity and most importantly… keeping your sense of humor! These topics will be addressed. 223

Sat., Sept. 22- Canadian Regulatory- 1:40 to 2:25
Financial Benefit of Research in Canada
Stephen Garland, Corporate Director of Business Operations, Pharmaceutical Integrated Research Corporation
The Canadian business environment is such that there are many incentives and advantages for innovation and research to be conducted in Canada. This session will appeal to both Canadian and non-Canadian organizations involved in clinical research (sites, CRO, and pharmaceutical companies) and will identify these financial benefits and strategies to capitalize on Canada’s pursuit of innovation. 225

Sat., Sept. 22- Canadian Regulatory- 2:30 to 3:15
SOPs: Good for My Site or Just More Work for the Coordinator?
Christine Hegi, CCRP, RN
President, Hegi Research Corporation
The presentation will discuss the pros and cons of having SOPs customized for their site. Is there actual benefit from the development of SOPs or is this just another burden placed on the coordinators by the regulatory authorities and sponsors. There will be some presentation on the current regulations for site SOPs and audit results. 227

Sat., Sept. 22- Canadian Regulatory- 3:35 to 4:20
The Rick Hansen Institute: Moving Spinal Cord Injury Clinical Research into Clinical Practice
Erin Cherban, MSc, CCRP
Director, Clinical Research Operations, Rick Hansen Institute
In 2004, the Rick Hansen Spinal Cord Registry (RHSCIR), a national, prospective, observational registry for traumatic spinal cord injury was established, creating a new clinical research network. Subsequently, the Rick Hansen Institute was established as the national centre and currently sponsors various types of clinical research (including clinical trials) and clinical implementation projects. This presentation will focus on the lessons learned from creating a national registry and a national clinical research network, and the current innovation driving the network – ensuring that clinical research results are implemented into clinical practice to rapidly improve patient outcomes. 229

Sat., Sept. 22- Canadian Regulatory- 4:35 to 5:20
Staying Competitive in the Canadian Environment: Operational Efficiency
Pamela Degendorfer, MA, CCRP, Director of Cancer Clinical Research Unit, Princess Margaret Hospital
Ms. Degendorfer will discuss the strategy developed by Princess Margaret Hospital to review operational efficiencies, performance measures, and highlight fiscal responsibility for clinical research in the Princess Margaret Hospital Cancer Program. The hospital benchmarks their metrics so they understand where they rank globally. They have improved processes and timelines to ensure they remain globally competitive and they can bring in new trials and novel treatments for their patients. 231

Track 3 - Training

Sat., Sept. 22- Training- 8:30 to 9:15
Evolution of a Clinical Research Education Program
Elsa Hwang, MA, MPH, CCRP, Clinical Research Project Manager, Memorial Sloan-Kettering Cancer Center
Developing effective trainings for clinical research staff is a challenge. Ms. Hwang will explain the evolution of the clinical research training program at Memorial Sloan-Kettering Cancer Center, from the first research staff orientation over ten years ago to the extensive program it has become. Methods on how to make trainings more interactive and user-friendly will also be discussed. 317

Sat., Sept. 22- Training- 9:20 to 10:05
The Selection, Care, and Feeding of Subject Matter Expert (SME) Trainers
Barbara van der Schalie, MS
Clinical Training Manager, SAIC-Frederick Inc
As the clinical research enterprise expands and the required knowledge and skill set becomes more extensive, the need for subject matter experts (SMEs) to serve as trainers also expands. Since the expertise of SMEs is in their subject area, they often need support in the design and implementation of effective training initiatives. This presentation will provide an overview of the use of SMEs as trainers including selection criteria and process, preparation and maintenance of training cohort and evaluation. 319

Sat., Sept. 22- Training- 10:50 to 12:25
Investigator Initiated Clinical Trials: The Nuts and Bolts of Trial Operations
Lenore Jackson-Pope, RN, MSM, ACRN, CCRP Manager, Medical Research & Education
Alzheimer’s Association
Michelle Culp, BSN, MPH, RN, Director, Office of Clinical Trial Operations & Management, NIH, NIDCR
This presentation will address issues encountered when working with investigators who receive NIH funding and industry grants to conduct investigator-initiated clinical trials. Based on their experiences, the presenters will discuss clinical trial operations including the basic nuts and bolts of what is needed for investigator-initiated clinical trial operations from protocol development to close-out of the clinical trial. 321/323

Track 3 - Statistics in Research

Sat., Sept. 22- Statistics in Research - 1:40 to 3:15
Demystifying Statistics for Study Coordinators
Jody Green, PhD, CCRP
Director of Research Administration
Denver Health, Rocky Mountain Poison and Drug Center
Dr. Green will illustrate the importance of statistical techniques in clinical trial study design as well as in patient management and interpretation of results. We will review statistical concepts, methods and tools used in clinical research, and utilize case studies to translate concepts to real-world situations. The session will aid participants in understanding the critical role of statistics in study development and study conduct, as well as in the interpretation of clinical study reports and scientific literature. 325/327

Track 3 - IRB

Sat., Sept. 22- IRB- 3:45 to 4:15
Review and Comparison of Grant Applications with Protocols by IRBs
Mira Shah, CIM, CCRP
Manager, Human Research Regulations
UT MD Anderson Cancer Center
This session will discuss how a comprehensive cancer center IRB reviews grant applications submitted for funding. The application is compared to the protocol approved by the IRB for human subject involvement before the funding is released. 329

Sat., Sept. 22- IRB- 4:15 to 4:45
Administrative Burdens of the IRB Review System
Laurin Mancour, BS, AS, RAC, CCRA, CCRP
Program Director, Clinical Trials
Durham Technical Community College
Ms. Mancour will discuss structural elements of an IRB and how this affects the review process, and will review the challenges and limitations of the current system of ethical review. Goals and current ideas for future IRB reform will also be discussed. 330

Sat., Sept. 22- IRB- 4:45 to 5:15
What Does the IRB Need for Review of a Medical Device Study?
Erica Heath, MBA, CIP, Director, Regulatory Affairs
E&I Ethical and Independent Review Services
Most IRB members and device professionals live in very different universes, yet each one must make important decisions for the other. Occasionally research professionals are caught in the middle and become the conduit for information between the IRB and the device company. Knowing more about who is reviewing the study, what criteria they use in reviewing device studies, the background they bring to the review, and what must be provided to them is critical information for a device professional. 331

Track 4 - Advanced Management

Sat., Sept. 22- Advanced Management- 8:30 to 9:15
Continuous Quality Improvement: Transitioning to a New Research Coordinator and Steps to the Path of Progress
Ashrafunissa Janmohammad, MBBS, MPH, MSc, CCRP, Research Coordinator, Pediatric Neurology
Victoria Hospital/LHSC
The importance of the role of a research coordinator in protocol execution and the role of the PI and research team in building foundations for an incoming research coordinator and streamlining success towards the path to progress will be discussed. This topic will emphasize the importance of the outgoing research coordinator and his/her preparation before the actual day of departing from the job and accepting a new role. 417

Sat., Sept. 22- Advanced Management- 9:20 to 10:05
How to Prepare Your Institution or Investigational Site to Hire Someone from Industry (CRO / Pharma)
Jeremy Whitson, BS, CCRP, CCRA, Research Operations Director, Southeast Renal Research Institute
Today many people are moving back to positions at academic institutions and investigational sites from jobs in industry for a number of reasons (too much travel as a CRA, downsizing, wanting a different career path, etc). This presentation will show ways for the site to prepare for someone coming from a different work environment but with the same goals- compliance to GCP and fiscal accountability. We will examine differences in preparing a budget, bringing the site into compliance with GCP, managing other CRCs and staff, and other general differences to consider that are usually not discussed between a CRA/project manager and the site. 419

Sat., Sept. 22- Advanced Management- 10:50 to 11:35
Strategies for Improving Quality Assurance in Imaging Trials
Dana Keane, BS, CCRP, CCRA
Clinical Trial Manager, Optos
Imaging in clinical trials has become more important than ever to help predict treatment outcomes, monitor disease progress and document treatment effectiveness. With the ever-present need for shorter, more cost effective trials, quality assurance in imaging is an essential component of ensuring trial success. This session will provide strategies for improving training and monitoring plans, site relations, and imaging protocols to ensure quality in imaging trials. 421

Sat., Sept. 22- Advanced Management- 11:40 to 12:25
Informed Consent Revisited: Strategies for Improving the Informed Consent Process
Becki Kanjirathinkal, MS, RN, CPHQ, CMQ/OE, CPHRM, Risk Control Consulting Director, CNA Insurance
Much as been written about the importance of designing informed consent forms to be understandable to potential research subjects, to meet federal regulation requirements, and to comply with ethical principles governing clinical research. The informed consent form is only a portion of the informed consent process. This session will explore best practices that clinical researchers can adopt to promote understanding and knowledge retention among potential research participants, meet regulatory requirements, and minimize risk exposures. 423

Sat., Sept. 22- Advanced Management- 1:40 to 2:25
Clinical Trials Registries
Belinda Vandersluis, BA, CCRP
President, Effector Consulting
This session describes clinical trials registration and results disclosure requirements, and consequences for noncompliance. It will also provide an overview of the evolution, importance and current state of clinical trials registration and results disclosure and regulatory requirements. Various platforms in the US, Canada, Europe, India, as well as issues regarding pharma industry-specific registries and requirements will be described. This session will also provide suggestions for research administrators to track and follow up on their institution’s responsibilities and registrations. 425

Sat., Sept. 22- Advanced Management- 2:30 to 3:15
How Not to Ruin a Perfectly Good Product with a Perfectly Flawed Study Design
Debbie Wilkerson, PhD
Clinical Research Director, Medtronic Spine and Biologics
With all the regulations/guidances currently available, there are still major issues with study design. The data monitor found that 58% of Phase III clinical trials are unsuccessful, with the primary cause for failure being the inability of the data to demonstrate efficacy of the tested product against placebo. This talk will address the critical role that study design plays in determining if a product is safe and effective. 427

Sat., Sept. 22- Advanced Management- 3:45 to 4:30
Pharmacist in Research: Interactions with Clinical Staff
Harvey Arbit, PharmD, MBA, CCRP, RAC, President, Arbit Consulting, LLC
Pharmacist clinical drug trial coordinators can assist in various aspects of research, from obtaining supplies, educating staff, developing randomization charts to bookkeeping. 429

Sat., Sept. 22- Advanced Management- 4:35 to 5:20
Effective Strategies for Delivering Informed Consent
Lynn Kunkel, MS, CCRP, Senior Research Associate, Oregon Health & Science University
The informed consent process is one of the most important steps in the successful implementation of clinical trials. It is also one of the most complex and challenging. Many times training research staff to conduct informed consent efficiently and effectively is overlooked. During this presentation, experiences from approximately 100 walk throughs will be discussed, highlighting the approaches that were most effective for gaining full informed consent. 431

Track 5 - Enrollment

Sat., Sept. 22- Enrollment- 8:30 to 9:15
Feasibility in Clinical Trial Subject Recruitment
Nancy Wintering, BA, MSW, LCSW, CRC, CCRP Research Program Manager, Thomas Jefferson University
Meeting the expected study enrollment is a challenge for sponsors, sites, investigators, and research staff. Often the enrollment goals are not achieved. This session will focus on several aspects of feasibility in clinical trials that enroll human subjects: assessment of protocol design, strategies to meet enrollment, and obstacles and barriers to success. Suggestions for developing effective collaborative relationships to achieve enrollment will be provided. Ethical considerations for culturally competent recruitment and enrollment of vulnerable populations will be discussed. 517

Sat., Sept. 22- Enrollment- 9:20 to 10:05
Recruitment and Retention in Pediatric Clinical Research Trials
Janelle Allen, MS, Research Coordinator
Cincinnati Children’s Hospital Medical Center
This session will focus on successful strategies to bolster recruitment and maintain retention over the course of trial timeline. Methods used within five successful clinical trials in the areas of Type I Diabetes, Childhood Headache, and Adolescent Headache will be presented. Discussion should be especially applicable to any clinical trial focusing on the pediatric population. 519

Sat., Sept. 22- Enrollment- 10:50 to 11:35
Site Subject Recruitment Planning and Implementation
Kevin Ketels, MS, CEO, KMED Marketing
Kevin Ketels will review the comprehensive planning process for developing a subject recruitment strategy from initial planning, timeline development and definition of success metrics. We will review several subject recruitment tactics including internal clinic/hospital chart reviews/referrals, physician referrals, mass media advertising, marketing collateral (flyers, protocol recruitment guides) , direct mail, social media, website usage, subject compensation and database management. Finally, this session will prepare participants on training requirements for staff who are involved in the subject recruitment function. 521

Sat., Sept. 22- Enrollment- 11:40 to 12:25
Informed Consent Overview
Olga Richter, BA, MA, CCRP, Supervisor, Clinical Research Coordinator, Cancer Center CRO, Mayo Clinic
The presentation will focus on the following content: timeline and history in the development of informed consent; essential, additional, and suggested elements of informed consent (including a thorough overview of the 9th required element – registration of clinical trials on clinicaltrials.gov); and examples of audit findings pertaining to informed consent and their possible prevention. 523

Sat., Sept. 22- Enrollment- 1:40 to 2:25
Exception from Informed Consent: It is a New Era for Clinical Research
Lori Wood, BSN, RN, CCRP, CPHN, Trauma Clinical Research Nurse, Scottsdale Healthcare Research Institute
The National Institutes of Health and healthcare professionals in the field of trauma are now seeing the significance of injury in trauma populations and the need for clinical trials. In order for clinical trials to occur in this population, the exception from informed consent (EFIC) process must be utilized. This presentation will review what must be done in order to conduct an EFIC trial at an institution, including community surveys, education, IRB education, and IRB application, as well as how to properly use the EFIC process in a prospective clinical trial. 525

Sat., Sept. 22- Enrollment- 2:30 to 3:15
The Nuts and Bolts of Staff Training and Retention
Linda Andrzejewski, RN, CCRP
Oncology Clinical Research Coordinator
Capital Health Medical Center - Hopewell
Training and retention of qualified research personnel who produce a high quality of work is key to ensuring the success of any research project or study. Many times, research is budgeted so that the coordinator is responsible for many duties and no one is budgeted to provide training. This session will describe how to take command and organize the workload and not let anything “fall through the cracks.” This session is not about SOPs but is a discussion of actual training and a mentorship approach that will strengthen research personnel confidence, lessen discouragement, and lessen staff turnover. The mentorship model can be applied to all areas of human subject research. 527

Sat., Sept. 22- Enrollment- 3:45 to 4:30
Effective Recruitment Methods, Strategies, and Tools that Accelerate Enrollment
Ruben Rodarte, MBA, MS, CCRP, Clinical Projects Director, LSU-Pennington Biomedical Research Center
This session will focus on exploring various recruitment models, strategies, and infrastructure elements and how they can improve enrollment. Learn how to integrate e-tools and resources that are widely available into your recruitment operations. The session will also touch on a few relevant marketing principles and share some cost effective advertisement tips. 529

Sat., Sept. 22- Enrollment- 4:35 to 5:20
Obtaining Informed Consent: It’s a Process, Not a Form!
John Furlong, RN, Director of Clinical Research, Thomas Jefferson University Hospital for Neurosciences
This presentation will discuss the importance of the ICF process and, in specific, the requirements for documenting the informed consent process. 531

Track 6 - Monitoring / SOP

Sat., Sept. 22- Monitoring / SOP- 8:30 to 9:15
SOPs in a Site Network Environment
Cheryl Jacobs, BA, CCRP, Vice President, Research Operations, Translational Research Management
Standard operating procedures are important in all aspects of clinical research. Within a site network environment they are an essential component in providing structure for sites new to research, for training site staff, and for establishing uniform expectations with trial sponsors. 617

Sat., Sept. 22- Monitoring / SOP- 9:20 to 10:05
Sponsor-CRO Alliance Partnerships: Monitoring SOP Considerations
Carolyn Rugloski, BA, MSc, CCRP
Senior Project Manager, Paragon Biomedical
Ms. Rugloski will conduct an interactive discussion concerning optimal Sponsor-CRO-Study Site preparation to achieve successful adherence to practical monitoring SOPs according to GCP standards. 619

Sat., Sept. 22- Monitoring / SOP- 10:50 to 11:35
The Monitor’s Role in the Recruitment Lifecycle: Setting Realistic Recruitment Goals, Monitoring Enrollment Progress, and Managing Underperformance
Nariman Nasser, BS, CCRP, Director, Participant Recruitment Service, University of California San Francisco
This presentation will review the CRA’s role in establishing and managing recruitment goals and implementing effective SOPs to set realistic goals. 621

Sat., Sept. 22- Monitoring / SOP- 11:40 to 12:25
Advanced Monitoring Skills - Beyond the Basics
Linda Mattson, MPA, BS, CCRA, Clinical Research Consultant
Ms. Mattson will explore areas that require more attention in our monitoring visits, discuss approaches to educating investigators and site personnel that are more effective than simple verbal and written instruction, and discuss “hot topics” requiring additional thought and attention for site monitoring, brought about by recent changes in FDA guidelines. 623

Sat., Sept. 22- Monitoring / SOP- 1:40 to 2:25
The Two are We: I Need You, and You Need Me!
Kristen Roggenkamp, BS
Senior Regional Clinical Research Associate, BIOTRONIK Inc
This presentation will discuss the delicate relationship between the monitor and site staff. Ms. Roggenkamp will review possible reasons why the relationship can be strained between a monitor and site staff, prospective pitfalls, and how to improve communication between the sponsor/monitor/site. 625

Sat., Sept. 22- Monitoring / SOP- 2:30 to 3:15
Corrective Action Plans and Their Role in Clinical Trial Management
Victoria Gashwiler, BSN, RN, CCRP
Senior Field Clinical Research Associate, Abbott Vascular
During the course of all clinical trials, deviations from the protocol and GCP are inevitable. Sponsor response, management, and oversight of these deviations can sink or swim the sponsor and/or sites during routine FDA audits. A thorough review of effective as well as ineffective Corrective Action Plans and their subsequent results will be discussed as well as the best means for implementation. 627

Sat., Sept. 22- Monitoring / SOP- 3:45 to 4:30
Monitoring to SOPs and CAPAs: Striving to Attain Clinical Trial Excellence
Carol Connell, PhD, RN, Director, Specialty Care Medicines Development Group, Pfizer Inc.
Dr. Connell will discuss the importance of Standard Operating Procedures (SOPs) and Corrective and Preventive Action plans (CAPA) in relationship to sponsor monitoring obligations. 629

Sat., Sept. 22- Monitoring / SOP- 4:35 to 5:20
Training in SOPs and Therapeutic Area for Monitors: Program and Approaches
Anatoly Gorkun, MD, PhD
Senior Manager, Training and Standards, MedImmune
Dr. Gorkun will discuss development of training programs and application of training techniques for monitors. Blended learning will be discussed. 631

Track 7 - Oncology Research

Sat., Sept. 22- Oncology Research- 8:30 to 9:15
Opportunities and Challenges in the Conduct of Oncology Clinical Trials
Sheri Smith, MS, President, Courante Oncology LLC
There are many interesting opportunities and challenges associated with conducting trials in oncology, particularly in the era of personalized medicine, reduced R&D expenditures, reduced patient availability in the western world, and increased regulatory oversight. These topics will be discussed, along with different approaches that have been used to anticipate opportunities and meet challenges. 717

Sat., Sept. 22- Oncology Research- 9:20 to 10:05
Developing Early Phase Cancer Prevention Trials
Anne Tompkins, MSN, CCRP, RN, Head, Protocol Information Office, Division of Cancer Prevention
National Cancer Institute, National Institutes of Health
This talk will focus on developing early cancer prevention trials. Ms. Tompkins will discuss developing objectives, defining endpoints, use of biomarkers, and accrual issues. Participants will be given an opportunity to share their perspectives on opening a cancer prevention study in their practice. 719

Sat., Sept. 22- Oncology Research- 10:50 to 11:35
Streamlining Study Start Up for Community Oncology Trials
Shelley Stoltz, BFA, CCRP
Quality Assurance Associate, ACORN Research LLC
Frequently, community oncology sites are contacted about participating in trials before given crucial information, such as the budget or protocol. How do sites deal with the unspoken expectations of following sponsor/CRO timelines or otherwise not being chosen for the trial? How do coordinators manage their principal investigator’s expectations given the twists and turns frequently involved in opening a trial? Ms. Stoltz will discuss how sites can “take back” timelines and streamline their processes for opening trials, all while avoiding confusion, decompressing stressful expectations, and staying within their capabilities. 721

Sat., Sept. 22- Oncology Research- 11:40 to 12:25
Quality Through Education, Standardization, and Best Practice Principles in Oncology Trials
Susanna Sellmann, BSc, CCRP, MRT, Quality Manager, Cancer Clinical Research Unit, Princess Margaret Hospital
This talk will discuss how to improve quality at the site based on the Plan-Do-Check-Act quality cycle. 723

Sat., Sept. 22- Oncology Research- 1:40 to 2:25
Using PedsOPAL to Assess Research Workload
Amanda Galster, MPH, CCRP, Regulatory and Clinical Research Manager, University of Minnesota
PedsOPAL is a set of instruments that can be used to score protocol complexity in pediatric oncology research. The PedsOPAL scores can be used to measure regulatory workload as well as subject caseload. These measures can be used to calculate staffing ratios. 725

Sat., Sept. 22- Oncology Research- 2:30 to 3:15
Developing Sponsor SOPs for Oncology Investigator-Initiated Studies
Rosanna Yankanah, Hons BSc, CCRP
Clinical Research Associate, Hospital for Sick Children
Conducting an investigator initiated study at an academic site, especially one which is a multi-centre trial, requires vigilant oversight. The responsibilities of the clinical trial research team begin well before the activation of the study. They need to develop an appropriate protocol, allocate required resources and implement strategies to ensure compliance with applicable regulatory authorities. The speaker will discuss the development and implementation of a comprehensive SOP for investigator-initiated trials and how to ensure investigator oversight and adherence to ICH-GCP through the use of the SOP and its associated supplemental documents. 727

Sat., Sept. 22- Oncology Research- 3:45 to 4:30
QA/Monitoring Tool for a Risk-Based Approach to Oncology Monitoring
Pamela Degendorfer, CCRP
Chief Operating Officer, Ozmosis Research Inc.
This presentation will review a monitoring/QA tool that evaluates site quality in order to implement risk-based monitoring. This tool was developed in an oncology setting and quantifies site quality from a monitoring perspective, thereby allowing a site tailored approach to monitoring frequency and oversight. 729

Sat., Sept. 22- Oncology Research- 4:35 to 5:20
Internal Monitoring for Continuous Improvement in Investigator-Initiated Oncology Trials
Susan Devine, CCRP
Senior Manager - CTSU, Hospital for Sick Children
Planning and implementing investigator-initiated trials requires extensive skills on the part of the research coordinator supporting the sponsor/investigator. An important area of focus of a sponsor is quality assurance. Susan Devine will review the internal monitoring processes of a pediatric oncology academic site and how the processes are used to aid in the quality assurance of investigator-initiated projects. 731

Track 8 - Poster Session

Sat., Sept. 22- Poster Session- 8:30 to 10:05
Bryce Warren, PhD
Chairman, L. H. Warren Foundation for Science
Joanne Goldberg, MSc, BSc, pht, CCRP, Associate Director, Inst. of Aging, Canadian Institutes of Health Research
Selected poster presenters will present a synopsis of their work related to Clinical Trials and Clinical Trials Management. 817/819

Track 8 - Research Ethics

Sat., Sept. 22- Research Ethics- 10:50 to 11:35
Is There Room for Altruism in Clinical Trials?
Seanda Blocker, MSN, RN, CCRP, CCRA
Senior Clinical Research Associate, Barblock LLC
Some members of the public view clinical research through a pessimistic lens. For such people, the mention of clinical research brings about thoughts of questionable ethics of pharmaceutical companies, research for the purpose of research rather than for providing needed treatment for challenging indications, and lack of provision of treatments for underserved populations. This presentation will discuss the necessity of altruism in clinical trials through review of past clinical trials appearing to possess little or no regard for altruism. Ms. Blocker will assess the need to integrate altruistic methods in current research, and provide recommendations for implementing clinical trials. 821

Sat., Sept. 22- Research Ethics- 11:40 to 12:25
Palliative Care and Research
Shirley Roach, BA, MSHS, RN, CCRP, Regulatory Project Manager, Allied Technology and Consulting, LLC
Ms. Roach will consider the ethical issues involved in palliative care research and discuss the vulnerabilities of this population. This session will also consider dying patients involved in clinical research and associated patient-family interactions. 823

Track 8 - Project Management

Sat., Sept. 22- Project Management- 1:40 to 2:25
Project Development and Management of Investigator Initiated Studies
Kimberly Kasprowicz, MS, RN, FNP
Clinical Research Associate, Welch Allyn
This discussion will outline how to collaborate and develop investigator protocols including addressing risks and benefits, IRB submissions, project management, and project oversight. 825

Sat., Sept. 22- Project Management- 2:30 to 3:15
Leveraging Infrastructure for Clinical Trial Conduct
Ruth Cavalieri, BSN, RN, CCRC, CCRP, Clinical Research Nurse, University of Nebraska Medical Center
Conducting clinical trials in the hospital environment can present time consuming and costly logistics challenges. The purpose of this presentation is to report how one site used existing clinical infrastructure to develop the logistical methods used for an inpatient clinical trial that evaluated whether bathing with chlorhexidine (CHG) reduces healthcare associated infections (HAI). 827

Sat., Sept. 22- Project Management - 3:45 to 5:20
Practical Tools to Manage the 5 Phases of Project Management in Clinical Trials
Handout
Brenda Kirpach, BA, CCRA, US ASPREE Project Manager, The Berman Center for Clinical Research
Cynthia Stowe, MPM, BA, CCRP
Project Manager, Wake Forest University School of Medicine
The objective of this presentation will be to describe the 5 phases of clinical trial projects and their outputs and to provide discussion and examples of tools and management solutions to use within each phase. This will be an interactive session presenting and discussing the tools used in clinical trials that coincide with the 5 phases of project management. The session will allow participants to share challenges and best practices within their own environments as a catalyst for the presentation of real take home solutions and tools for all levels, from site coordination to coordinating center. 829/831

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Sunday, September 23, 2012
Closing Plenary Session

Sun., Sept. 23- Closing Plenary- 8:30 to 8:40
Poster Recognition Award Presentation
Bryce Warren, PhD, Chairman, L. H. Warren Foundation for Science 932

Sun., Sept. 23- Closing Plenary- 8:40 to 9:15
Drug Development for Rare Disorders
Lisa Coles, PhD. MS, Post-Doctoral Fellow, Center for Orphan Drug Research, University of Minnesota
Rare diseases are frequently chronic, life-threatening, and debilitating diseases that significantly impact patients’ lives. Drug development for these conditions has been limited by challenges related to the availability of subjects for clinical trials, the lack of understanding of the underlying mechanism of the disease, funding for research in rare conditions, and lack of financial incentives to bring drugs to market. Nevertheless, studies are feasible using novel and creative methods. Dr. Cloyd will consider how the Orphan Drug Act (passed in 1983) has helped overcome many of these challenges by providing incentives for the development of orphan drugs. 933

Sun., Sept. 23- Closing Plenary- 9:15 to 9:50
The Pitfalls and Strategies for Conducting Clinical Research in Nonconventional Locations
Handout
Lawrence Korman, RN, BSN, CCRP, Nurse Protocol Coordinator, United States Army Medical Research Institute of Infectious Diseases
Clinical research initiated within the United States that utilizes nonconventional international sites requires unique adaptation to overcome unexpected challenges. These challenges encompass numerous areas such as logistics, staffing, monitoring, and even country stability concerns. As clinical research staff we must prepare for and understand these challenges to prevent negative study outcomes. 935

Sun., Sept. 23- Closing Plenary- 10:10 to 10:45
Managing a Multigenerational Workforce
Handout 1
Handout 2
Handout 3
Handout 4
Handout 5
Rosemarie Christopher, MA
President and CEO, MEI/RxRS
Technology, social influences and the economy are responsible for new work performance paradigms. While subject expertise, work ethic and interpersonal skill sets are the standard set for judging workplace performance, how each of the four generations views and delivers on those standards are quite different, making managing a multi-generation workforce a daily challenge. Ms. Christopher will provide a few tools that will make the process manageable and empowering for all concerned. 936

Sun., Sept. 23- Closing Plenary- 10:45 to 11:20
Cancer Vaccines - The Immune System at Work
Doreen Higgins, BSN, CCRP, RN, CBCN
Research Nurse, University of Washington
Doreen Higgins will describe how the immune system fights cancer using a vaccine. A quick history and overview of immunotherapy and vaccines will be presented. Explanation of how cancer vaccines work and the difference between the different types of vaccines will be presented. 937

Sun., Sept. 23- Closing Plenary- 11:20 to 12:00
Preventing Medical Errors in Children: Focusing on Homes
Katie Walsh, MD, MS, MSc, Assistant Professor of Pediatrics, University of Massachusetts Medical School
This talk will review rates and types of home medication errors in children with chronic conditions. We will discuss strategies to prevent medication errors including; communication strategies, web-based supports, and low tech interventions. Future directions for supporting the home use of medications in patients will be discussed. 938

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