ACRP 2018 Meeting & Expo

Apr 27, 2018 ‐ Apr 30, 2018



Sessions

Data-Driven Communication: What it is and How You Can Use it to Engage Research Stakeholders

Apr 30, 2018 8:15am ‐ Apr 30, 2018 9:15am

Identification: 314

Credits: None available.

Learn how to take a strategic approach to digital communications - underpinned by a metrics model - by hearing lessons learned from those managing the website and social media channels for PCORnet, the National Patient-Centered Clinical Research Network. Speakers will explore the cyclical process of data-driven communication from development through analysis, recommendations, and improvements. Explore opportunities to leverage social media channels in clinical research and hear best practices and case studies. Leave with an greater understanding of audience segmentation and engagement, and how a metrics model can be used to measure digital channel performance and inform website and social media strategy.

  • Understand the purpose and benefits of data-driven communications
  • Learn how to develop a digital channel metrics model to assess performance and track user engagement and interaction
  • Gather recommendations to inform decision-making about the future direction of your organization’s/study’s/research program’s digital channels

Speaker(s):
  • Margaret McAdams, MS, CCRA, Clinical Research Communications Specialist, Duke Clinical Research Institute
  • Julie Schulman, MS, Content Development Manager in Medical Education and Training, Springer Healthcare
Members: $25.00
Standard: $75.00

What's Next in Satellite Sites: A Sponsor and Site Perspective

Apr 30, 2018 9:30am ‐ Apr 30, 2018 10:30am

Identification: 321

Credits: None available.

Hear a firsthand account of sponsor and site perspectives on managing and conducting a large, multicenter medical device trial involving a large network of satellite sites. Presenters will discuss the emergence of satellite sites in the current climate of hospital mergers with healthcare networks and/or clinics merging under a single healthcare entity. Leave with a clear understanding of what a satellite site is, the ability to evaluate whether a satellite site is suitable for clinical trial conduct, and the knowledge to apply this information to current practices.

Learning Objectives:

  • Identify satellites sites - early detection is key but identification can occur at all stages of a clinical trial
  • Implement best practices: e.g. Early detection; Discussions at interest visits, site qualification visits and site initiation visits; Ongoing evaluation during study conduct; IRB oversight (Local and/or Centralized)
  • Apply appropriate study conduction: e.g. Subject enrollment and tracking; Subject follow ups and assessments; Investigational device management; Housing and maintenance of study documents; Study staff at satellite locations; Monitoring, PI oversight and Safety reporting management among other topics

Speaker(s):
  • Sherani Amarasinghe, MS, CCRA, CCRP, Senior Clinical Research Associate, Boston Scientific
  • Denise K. McDermott, MSN, RN, CCRC, Research Nurse, North Shore University Hospital, Northwell Health
Members: $25.00
Standard: $75.00

CDER BIMO Compliance and Enforcement: What You Need to Know

Apr 30, 2018 9:30am ‐ Apr 30, 2018 10:30am

Identification: 322

Credits: None available.

Join FDA personnel from the Center for Drug Evaluation and Research as they discuss key opportunities for the clinical research industry to make their FDA inspection experience a positive one. The speaker will outline recent inspection trends and identify key strategies to build quality into clinical research in order to prevent critical compliance issues. When problems do occur, inspected entities should be able to respond appropriately. Take away practical approaches to working with the FDA during an inspection, responding to 483s after an inspection, and responding to subsequent regulatory correspondence.

Learning Objectives:

  • Identify recent trends in CDER-BIMO inspections of clinical investigators, sponsors, and IRBs
  • Describe key strategies for building quality into clinical trials
  • Describe key strategies for responding to FORM FDA 483s and Warning Letters

Speaker(s):
  • David Burrow, Pharm.D., J.D., Acting Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, FDA
Members: $25.00
Standard: $75.00

So You Want to be a CRA. Learn How the Role is Changing

Apr 30, 2018 9:30am ‐ Apr 30, 2018 10:30am

Identification: 323

Credits: None available.

Looking to become a clinical research associate (CRA)? Are you a current CRA wondering how the position is rapidly changing and how you can stay current? This session is for you. The speaker will give real-world perspective on how industry is changing, what it means to someone trying to break in, and what it all means for long-time CRAs. Learn about risk-based monitoring, eConsent, exciting new apps, developing technology, and how studies are changing in the way they monitor and look at data.

Learning Objectives:

  • Learn about the CRA role and the skills required to be a CRA
  • Learn about topics driving change for CRAs such as Risk Based Monitoring, Centralized Monitoring, increased use of technology
  • Learn about how the design of studies is changing, and how this affects the CRA position

Speaker(s):
  • Melissa Nezos, MA, Global Head, Clinical Monitoring Services, Premier Research
Members: $25.00
Standard: $75.00

Investigator Perspectives and Insights on the Use of Mobile Tech in Clinical Trials: Findings from CTTI’s Mobile Clinical Trials Project

Apr 30, 2018 9:30am ‐ Apr 30, 2018 10:30am

Identification: 324

Credits: None available.

New research from the Clinical Trials Transformation Initiative may help investigative sites prepare for the potentially disruptive shift toward greater use of mobile technology to capture objective patient data in clinical research studies. Presenters will summarize key findings from a series of in-depth interviews with investigators who have conducted both traditional clinical trials and studies using mobile technology, providing insights on the advantages and disadvantages to be aware of when running a trial with mobile technology, budgetary and training needs, and other important factors for investigative site personnel to consider. Explore findings from an initial online survey of potential research participants on the use of mobile technology in clinical research, and learn potential implications for clinical research sites.

Learning Objectives:

  • Understand investigator perspectives on the advantages and disadvantages of clinical trials that use mobile technology for collection of research data
  • Discuss site-level budgetary, training, and other support needs necessary to adequately prepare for and implement clinical research studies using mobile technology, as identified by investigators who have conducted such studies
  • Identify potential impacts of mobile technology on participant experiences in clinical trials

Speaker(s):
  • Virginia Nido, MS, Global Head, Industry Collaborations, Genentech, a Member of the Roche Group
  • Steve Morin, U.S. Food and Drug Administration
Members: $25.00
Standard: $75.00

2018 Regulatory Year in Review2018 Regulatory Year in Review

Preview Available

2018 Regulatory Year in Review

Apr 30, 2018 1:45pm ‐ Apr 30, 2018 2:45pm

Identification: 331

Credits: None available.

Review new laws and regulations passed (or pending passage) within the previous 12 months that are generally not intended to directly govern the clinical research industry but certainly will have direct or indirect impacts and intended or unintended consequences. The speaker will lead an engaging and lively discussion of the regulatory year in review at this always-popular and provocative session.

Learning Objectives:

  • Recall the relevant portions of the varying laws and regulations discussed.
  • Analyze the potential impact that the laws and regulations bring to the research industry.
  • Interpret how the laws and accompanying regulations affect them.

Speaker(s):
  • David Vulcano, LCSW, MBA, CIP, RAC, AVP & Responsible Executive, Clinical Research, HCA
Members: $25.00
Standard: $75.00

Applying Implementation Science to Improve the Quality of Clinical Trials in Academia

Apr 30, 2018 1:45pm ‐ Apr 30, 2018 2:45pm

Identification: 332

Credits: None available.

Unlike clinical studies conducted by industry in which companies provide monitors to help verify data quality, studies conducted in academia often lack such oversight. These investigator-initiated studies would benefit from internal monitoring by, for example, a group of research personnel who might monitor each other’s trials. While all research professionals are frequently training on Good Clinical Practice, the tactical instructions on how to achieve positive outcomes - including approaches to proper monitoring - are lacking. Learn about a novel learning module developed and launched to address this need and an applied framework based on applied science to maximize its effectiveness. The speaker will discuss reasons and methods for developing this initiative, as well as implementation strategies, tools utilized to assess successful implementation, and findings.

Learning Objectives:

  • Understand the necessity for quality initiatives in investigator-initiated clinical trials
  • Understand how an implementation science framework can be used to improve the effectiveness of training initiatives
  • Understand metrics used to determine the success of the training initiative and the resulting findings

Speaker(s):
  • Amelia Spinrad, RegulatoryScience MS Candidate, Regulatory Knowledge Support Specialist, University of Southern California
  • Eunjoo Pacifici, PharmD, PhD, Director of the USC International Center for Regulatory Science and Assista, University of Southern California
Members: $25.00
Standard: $75.00

Back from the Brink: Rescuing a Clinical Research Site

Apr 30, 2018 1:45pm ‐ Apr 30, 2018 2:45pm

Identification: 333

Credits: None available.

Many clinical research sites are operated in organizations that are not otherwise focused on research. At times, such sites might encounter problems that threaten patient safety, study integrity, and the future of their engaging in research. Poorly performing sites can experience poor investigator and participant satisfaction, negative net revenue, and meager quality. A poorly performing site is also at enhanced risk for termination by the parent organization during cost reductions. Drastic actions could be needed to recover the capability of these sites to perform quality research. Come explore how sites might find themselves in such a circumstance, ways to identify what is and is not working, taking corrective actions, and solidifying those actions into a research program focused on quality.

Learning Objectives:

  • Assess strengths and weaknesses of a clinical research site
  • Implement corrective actions for site recovery
  • Advance a clinical research program emphasizing quality

Speaker(s):
  • Steven Ziemba, PhD, FACHE, FACRP, Lead IRB Reviewer and Assistant Professor, Northcentral University
Members: $25.00
Standard: $75.00

Transitioning from CRC to CRA: The Why, When, and How to Make it Happen

Apr 30, 2018 1:45pm ‐ Apr 30, 2018 2:45pm

Identification: 334

Credits: None available.

Gain the tools and knowledge needed for an efficient transition from study coordinator to monitor. Speakers will share their personal experiences in making the transition, including successes, lessons learned, and effective methods for getting on the monitor career path. Take away a checklist that you can use during your transition, as well as the ability to determine the right time for your career move, to evaluate your competencies and gaps in preparation, and to address your needs during the onboarding process.

Learning Objectives:

  • Identify the why and how of this career change, including the certifications and education desired by sponsors and CROs
  • Understand a day in the life of a new CRA, such as travel responsibilities and working remotely
  • Recognize the new company expectations as well as your professional development and training needs

Speaker(s):
Members: $25.00
Standard: $75.00

What Makes a Great CRA – A 360 Degree Perspective

Apr 30, 2018 1:45pm ‐ Apr 30, 2018 2:45pm

Identification: 335

Credits: None available.

While beauty may be in the eye of the beholder, views of CRA competency and proficiency also rest in the eyes of different stakeholders. A hiring manager will naturally have a different perspective than the site staff being monitored. And while the industry struggles with the age-old myth that to be a "good" CRA (or be hired as a CRA) you need to have at least two years of experience as a CRA, the situation is becoming even more complex as the traditional role of the CRA is ever evolving. In this dynamic panel discussion, four industry experts will share their observations on the critical knowledge, skills and abilities essential for a great CRA, how these can be developed and assessed and why it is important to consider a holistic view of CRA performance from different perspectives.

Learning Objectives:

  • Describe some key elements that different stakeholders (site, CRO, sponsor) hold most critical for a successful CRA
  • List some ways that sponsors and CROs groom and grow CRAs ensure they are competent and successful
  • Discuss ways in which the site’s view of CRA performance can be a valuable way to enhance the quality of the CRA workforce

Speaker(s):
  • Amanda Wright, Bachelors Degree, Executive Director, Greater Gift
  • Lynn King, BA, MHA, Executive Director, Clinical Management, North America Regional Head, PPD
  • Patricia Cataruozolo, PhD, MS, BSN, RN, Director, Clinical Site Management, Global Clinical Site Management, Pfizer
  • Jaylene Weigel, RN, MSN, MBA-HCM, CPN, CCRC, Director, Clinical Research Operations, Children’s Mercy Kansas City
Members: $25.00
Standard: $75.00