ACRP 2018 Meeting & Expo

Apr 27, 2018 ‐ Apr 30, 2018



Sessions

Practical Strategies for Building Lasting Relationships Between Sponsors and Sites

Apr 28, 2018 11:30am ‐ Apr 28, 2018 12:30pm

Identification: 131

Credits: None available.

"Coming together is a beginning," said Henry Ford. "Keeping together is progress. Working together is success." How do you build a solid sponsor-site working relationship from site identification to closeout and beyond? Checking the appropriate boxes for qualification is a great start, but the goal is to build relationships that continue beyond closeout into the next clinical research project. Learn the key communications between sponsors and sites that set the framework for the duration of a clinical research project. Speakers will pull from their collective 30+ years of experience to present case studies from both sponsor and site perspectives. Take away practical tips for preventing sponsor-site relationship challenges and solutions for resolving them when teamwork is compromised.

Learning Objectives:

  • Build better successful, long-term site/sponsor working relationships
  • Implement tips for more effective communication
  • More easily resolve sponsor/site conflict

Speaker(s):
  • Marcus Stone, PhD, CEO, Spine Institute of Louisiana
  • Jane Jacob, PhD, Vice President, Research and Clinical Affairs, Orthofix
Members: $25.00
Standard: $75.00

The Buck Stops with the PI. Or Does It? CRCs Gone Wrong

Apr 28, 2018 3:30pm ‐ Apr 28, 2018 4:30pm

Identification: 132

Credits: None available.

Regulation states that ultimate responsibility for a clinical trial rests with the principal investigator. But what happens when a coordinator "goes rogue" and is guilty of misconduct? The speaker will explore the definition of misconduct in clinical trials and the possible consequences of intentional misconduct by a coordinator. Hear actual case studies delineating coordinator sanctions and punishments, as well as reasons for committing fraud.

Learning Objectives:

  • Define Scientific Misconduct in Clinical Research
  • List Three Cases of Coordinator Misconduct
  • Describe the Consequences of Coordinator Misconduct

Speaker(s):
  • Janet Holwell, CCRC, CCRA, FACRP, TIACR, Clinical Research Consultant, Independent Consultant
Members: $25.00
Standard: $75.00

Ensuring Patient Safety and Ethics in the Trenches

Apr 28, 2018 3:30pm ‐ Apr 28, 2018 4:30pm

Identification: 133

Credits: None available.

This session will address the importance of ethics and patient safety with passion, props, and audience participation. Speakers will lead an active discussion of ethical and patient safety considerations related to informed consent, inclusion and exclusion criteria rationale, the difference between clinical care and clinical research, and much more.

Learning Objectives:

  • Understand the difference between clinical care and clinical research
  • Explain the rationale for Inclusion and exclusion criteria in a clinical protocol
  • Understand the ethical responsibility in the informed consent process

Speaker(s):
  • Shari Zeldin, BS, CCRC, Compliance Officer, UW Comprehensive Cancer Center
Members: $25.00
Standard: $75.00

Professional Development for CRCs: A Shared Responsibility

Apr 28, 2018 3:30pm ‐ Apr 28, 2018 4:30pm

Identification: 134

Credits: None available.

Receive guidance on how to analyze the professional development resources available and how to create an action plan to customize your own path for growth and advancement. Speakers will lead an open dialogue about development, tools, and strategies available, while challenging you to develop your own unique professional development track that is both defined and measurable.

Learning Objectives:

  • Define goals of personal professional education and development
  • Examine already existing programs for professional development and discuss benefits of participation
  • Develop a personalized plan for your professional development over the nextt few years

Speaker(s):
  • Joy Jurnack, RN CCRC CIP FACRP, Research Nurse, Northwell Health, Division of Kidney Research
  • Mindy Owen, RN, CCM, President, Phoenix Healthcare Association
Members: $25.00
Standard: $75.00

The Seismic Shift in the Monitoring Paradigm: From Quality Control to Quality Assurance

Apr 28, 2018 3:30pm ‐ Apr 28, 2018 4:30pm

Identification: 135

Credits: None available.

This session takes a practical approach to risk-based monitoring. Clinical monitors, project managers, and risk managers learn how to maximize their monitoring resources to have the greatest impact on quality and compliance. Learn about the shift in the monitoring paradigm from the quality-control approach of checking each data point against a source to a quality-assurance (QA) approach that focuses on the systems and processes that generate and report the data. Add the QA methods of interviewing and root-cause assessment to your monitoring toolbox as an effective means of determining the areas in which monitoring resources can have the greatest impact. The speaker will present real findings from a well-established audit program in a risk-based monitoring environment, as well as auditor suggestions, to help you avoid common mistakes.

Learning Objectives:

  • Discuss how the role of the clinical monitor is evolving in the new era of risk-based monitoring, and demonstrate how CRAs and project managers must modify their approach to clinical monitoring when taking a risk-based approach
  • Contrast system-based monitoring to source data verification-focused monitoring
  • Discuss common audit findings from risk-based monitoring and how they can be applied

Speaker(s):
  • Lysa Triantafillou, BA, Director, Quality Assurance, Rho
  • Susan Leister, BS, MBA, PhD, CQA, CSSBB, Vice President, Quality, Technical Resources International Inc.
Members: $25.00
Standard: $75.00

Clinical Research 3.0 - The Impact of Technology on the CR Professional of the Future

Apr 28, 2018 3:30pm ‐ Apr 28, 2018 4:30pm

Identification: 136

Credits: None available.

New technology is being introduced to clinical research operations so rapidly that it seems like a daily occurrence. At the same time, the roles of clinical researchers are changing as these tools are put into place. Some simplifying the work load, others seemingly making it more complex. This session will look at these trends and use a "crystal ball" to tell us the expectations of clinical researchers in the future.

Learning Objectives:

  • Discuss the need for new skill sets for site staff and site monitors
  • Describe different technologies that will have the greatest impact on the clinical research workforce
  • List some operational, ethical and regulatory considerations and concerns that must be addressed to realize the future

Speaker(s):
  • Craig Lipset, MPH, Head of Clinical Innovation, Global Product Development, Pfizer
  • David Vulcano, LCSW, MBA, CIP, RAC, AVP & Responsible Executive, Clinical Research, HCA
Members: $25.00
Standard: $75.00

Cost-Effectiveness Analysis Alongside Clinical Trials: A Primer

Apr 28, 2018 3:30pm ‐ Apr 28, 2018 4:30pm

Identification: 137

Credits: None available.

This session will provide a valuable introduction to contemporary healthcare economics and an understanding of its role. The pressure upon drug and device developers to provide more cost-effective therapies is significant and continually increasing. When conducting a clinical trial, the collection of important economic data in conjunction with medical and clinical outcomes is becoming more common. An understanding of the routine conduct of economic evaluations alongside the traditional analyses of safety and efficacy is important for all clinical research professionals. Speakers will review various pharmacoeconomic research designs (cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis, and cost-benefit analysis) using case studies, and explain the concept of quality-adjusted life years which has evolved into one of the leading outcomes in pharmacoeconomic evaluations.

Learning Objectives:

  • Describe the rationale for the need of economic outcomes data during the conduct of clinical trials
  • Explain the important economic concepts relevant to clinical research professionals
  • Compare and contrast the various forms of pharmacoeconomic research designs and utility

Speaker(s):
  • Marjorie Neidecker, PhD, MEng, RN, CCRP, Assistant Professor - Clinical, The Ohio State University
  • Charles Carter, BS, PharmD, MBA, Associate Professor, Campbell University
Members: $25.00
Standard: $75.00

Virtual Teams: Challenges and Rewards

Apr 29, 2018 10:15am ‐ Apr 29, 2018 11:15am

Identification: 201

Credits: None available.

Virtual teams spread over wide geographic regions and multiple time zones bring unique challenges for those charged with their leadership. Learn about the increased use of virtual teams and the key challenges when working with a virtual team. Hear examples and practical tips used by the speaker in building a virtual team from the ground up, and take away communication strategies to support commitment and engagement from all team members.

Learning Objectives:

  • Describe the industry conditions leading to increased use of virtual teams
  • Identify the challenges of working within a virtual team environment
  • Identify strategies for effective communication with virtual team members

Speaker(s):
  • Dawn Pedinelli, RN, BA, MBA, CCRC, CHRC, Director of Research Operations, Trinity Health
Members: $25.00
Standard: $75.00

“Oops, I Did It Again." How to Write a Simple (and Effective) CAPA Plan

Apr 29, 2018 10:15am ‐ Apr 29, 2018 11:15am

Identification: 202

Credits: None available.

Learn the basics of what makes a corrective and preventative action (CAPA) plan. Everyone makes mistakes in clinical trial conduct; but it's how mistakes are addressed that makes the difference between correcting the error or correcting the area and preventing it in the future. The speaker will provide a simple framework to formulate a process for developing a CAPA plan, and offer example plans to further illustrate the process. Leave with an understanding of CAPA implementation, communication, and follow-up considerations.

Learning Objectives:

  • Identify the key components of an effective Corrective and Preventative Action (CAPA) Plan
  • Develop a simple CAPA Plan Process
  • Implement and follow up on a completed CAPA Plan

Speaker(s):
  • Lisa Haney, BS, CCRC, Clinical Operations Manager, Lutonix/Becton Dickinson
Members: $25.00
Standard: $75.00

Using Data Analytics to Optimize Site Performance and Prepare for the Wave of Consolidation Impacting the Site Sector

Apr 29, 2018 10:15am ‐ Apr 29, 2018 11:15am

Identification: 205

Credits: None available.

Powerful forces are impacting the site sector, leading to accelerating consolidation of sites into integrated site operations enterprises, formerly called SMOs (Site Management Organizations). As a research professional and industry leader it is imperative to be proactive in combating these market forces. Learn the steps you can take today to implement processes and use data analytics to tout and display your site's therapeutic and operational strengths while proactively shoring up weaknesses. As a result, your site will witness enhanced value and long-term stability to enable it to thrive regardless of the powerful forces shaping the entire clinical trials industry and now cascading down to the site level.

Learning Objectives:

  • Understand the powerful market forces currently impacting the site sector
  • Understand how data analytics and site metrics tracking can enhance the enterprise value and long term stability of your site
  • Gain practical knowledge of steps you can take today to position your site to thrive regardless of the forces shaping the clinical trials industry

Speaker(s):
  • Barry Lake, CEO & Co-Founder, Devana Solutions, LLC
Members: $25.00
Standard: $75.00