ACRP 2018 Meeting & Expo

Apr 27, 2018 ‐ Apr 30, 2018



Sessions

A Framework for Competency-Based Tier Advancement: Lessons Learned

Apr 29, 2018 3:30pm ‐ Apr 29, 2018 4:30pm

Identification: 234

Credits: None available.

Learn about the Duke University School of Medicine's experience with a competency-based framework for career advancement. Building on last year?s session outlining the creation of competency-based job descriptions and the process used to match incumbents to these new classifications, speakers this year will address steps taken to provide advancement opportunities using objectively-measured competency assessments. Hear results of the initial tier advancement cycles, lessons learned, and how this tier advancement process is providing clearer career paths for staff while attracting and retaining a valuable workforce.

Learning Objectives:

  • Describe the benefits of a workforce initiative, built upon clinical research competencies
  • Detail the process and components of competency-based tier advancement for clinical research professionals
  • Describe the results of the tier advancement process for the clinical research workforce at an academic medical center

Speaker(s):
  • Rebecca Brouwer, MS, Director, Research Initiatives, Duke University
  • Deborah Hannah, MT(ASCP), CCRC, Research Practice Manager, Duke University Medical Center
  • Denise Snyder, MS, RD, Associate Dean for Clinical Research, Duke University School of Medicine
Members: $25.00
Standard: $75.00

Cloud-Based Remote Monitoring: Perspectives and Best Practices for Implementation

Apr 29, 2018 3:30pm ‐ Apr 29, 2018 4:30pm

Identification: 235

Credits: None available.

Come hear case studies of cloud-based monitoring and a conversation about how different stakeholders can cooperate to increase research effectiveness. Speakers will explore remote monitoring from the perspectives of the contract research organization, research site, and technology vendor. Learn about the impact of HIPAA-compliant, cloud-based subject binders, associate regulatory issues such as Certified Copy, and best practices for implementation.

Learning Objectives:

  • Facilitate regulatory compliant remote monitoring
  • Explain the role and importance of Certified Copy under FDA guidance and ICH-GCP E6 R2
  • Discuss best practices for handling cloud-based source and regulatory documents

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

eConsent: Improving the Consent Process through Innovative Technology

Apr 29, 2018 3:30pm ‐ Apr 29, 2018 4:30pm

Identification: 236

Credits: None available.

Imagine being able to consent a participant remotely. With today's new electronic data capture (EDC) systems, this is a reality. Come learn how to ethically and technically complete an electronic consent (eConsent) by using video, audio, and digital media. The speaker will present a live eConsent demonstration and help expand your consenting skills by empowering you to leverage your EDC system to save time and money.

Learning Objectives:

  • How to design an e-consent that meets and exceeds GCP and applicable laws
  • What tools can be used to enhance the consenting process
  • How to integrate video, audio and digital consent into one simple process

Speaker(s):
  • Leigh Mack, MD, PhD, CMO, Crucial Data Solutions
Members: $25.00
Standard: $75.00

Protocol Development for Device Studies: Optimizing Endpoint Selection for Maximizing Regulatory and Marketing Needs

Apr 29, 2018 3:30pm ‐ Apr 29, 2018 4:30pm

Identification: 237

Credits: None available.

Gain the tools you need to develop a protocol that meets regulatory and marketing needs through inquiries, surveys, and discussions. Developing device protocols that maximize impact while minimizing costs is difficult, and often does not reach the goal of generating data for both. Developing protocols that either meet the needs of both regulatory and marketing, or setting up post market studies that answer these questions, requires both detective and analytic capabilities. Speakers will shed light on the steps required to determine what data needs to be collected to answer these questions, or support the post market surveillance to do so.

Learning Objectives:

  • Determine what endpoints for Regulatory can do for Marketing
  • Developing strategies to collect data for marketing claims
  • Minimizing Sample size to answer both Regulatory and Marketing needs

Speaker(s):
  • Victor Chen, Director, Clinical Affairs, Align Technology
  • Christopher Cain, CCRA, RAC, VP, Clinical and Regulatory Affairs, Corindus Vascular Robotics, Inc.
Members: $25.00
Standard: $75.00

ACRP Certification Exam Prep: Part III

Apr 30, 2018 8:15am ‐ Apr 30, 2018 10:30am

Identification: 301

Credits: None available.

Planning to earn your ACRP Certification?

The newly-revised ACRP Certification Exam Preparation Course provides eligible candidates guidance on how to prepare for the ACRP certification exams -- CCRA(R), CCRC(R) and CPI(R). Familiarize yourself with the exam format, gain valuable strategies for preparing for an ACRP exam, tackle sample exam questions, and conduct a personal gap analysis to ensure you are fully primed to earn your ACRP certification.

This session is part of a three-part series that will take place Saturday, April 28 and Sunday, April 29 from 10:15 am - 12:30 pm and Monday, April 30 from 8:15 - 10:30 am.

Note that CEUs will not be provided.

Speaker(s):
  • John Rowell, MSN, RN, CCRC, Director of Cancer Clinical Trials Office, LSU Health-Shreveport
Members: $25.00
Standard: $75.00

Navigating SMART Central IRB Startup on the Clinical Trials Superhighway

Apr 30, 2018 8:15am ‐ Apr 30, 2018 10:30am

Identification: 302

Credits: None available.

Learn about innovative CIRB workflows developed by working groups of the National Institutes of Health-funded Trial Innovation Center (TIC). Speakers will outline how they have approached local context review and study site activation under the SMART reliance agreement for multi-center trials, among other topics. Hear how these innovative workflows are paving the way for future research and playing an integral role in accelerating the translation of research to the bedside. This session is a two-part "master series" program.

Learning Objectives:

  • Identify the technical issues of operationalizing a CIRB review model
  • Describe early workflow models for study teams; what has worked and not worked
  • Review approaches and operational principles to be in compliance with new regulations

Speaker(s):
  • Jeri Burr, MS, RN-BC, CCRC, FACRP, Executive Director, Utah Trial Innovation Center, University of Utah
  • Ann Johnson, PhD, MPH, Director, Institutional Review Board, University of Utah
  • J. Michael Dean, MD, MBA, Vice Chair for Research, Pediatrics, Director, Clinical Trials Office, University of Utah
Members: $25.00
Standard: $75.00

Financial Management for Research Sites: Maximizing Your Revenue Potential

Apr 30, 2018 8:15am ‐ Apr 30, 2018 10:30am

Identification: 303

Credits: None available.

Financial management for research sites is one of the most time-consuming and complicated aspects of the clinical research process. Learn several effective strategies for negotiating competitive budgets and contracts for a variety of different types of clinical studies. Speakers will delve into several different hurdles that sites of various setups must overcome, including unfair payment terms, coverage analysis, and claims review, among others. Explore different methods of receivable management, including how to know when renegotiating a budget or contract is possible. This session is a two-part "master series" program.

Learning Objectives:

  • Effectively negotiate the most competitive study budgets and contracts
  • Strategies to best manage your study receivables and know when renegotiation is appropriate
  • How to conduct full coverage analysis and claims review

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

Building Support and Recognition for Clinical Research and Your Role as a Leader

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

Identification: 311

Credits: None available.

Learn how to effectively gain support for moving clinical research from "just a small department" to part of the broader organizational culture. Hear proven techniques for gaining buy-in for a strategic plan and ongoing engagement, including group leadership, SWOT analysis, mission and vision development, and establishment of a research advisory board. Leave with proven strategies for gaining recognition for the program and establishing yourself as a peer among business leaders within your organization.

Learning Objectives:

  • Improve communication with organizational leadership through appropriate messaging and language
  • Lead a group through a SWOT analysis (strengths, weaknesses, opportunities and threats) to create a viable mission and vision for research
  • Create a research advisory board

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

Identifying and Documenting Adverse Events: A Decision Making Process

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

Identification: 312

Credits: None available.

Improve your understanding of adverse events (AEs) by working step-by-step through the definitions of the different types of AEs and reviewing the recording and reporting requirements of each. The speaker will provide a detailed review of AEs and requirements for assessment, documentation, recording, and reporting. Leave confident in your ability to effectively monitor AEs and ensure patient safety and data integrity.

Learning Objectives:

  • Participants will be able to describe a decision-making framework that will facilitate correct adverse event recording and reporting
  • Participants will be able to describe Investigator, Clinical Research Coordinator (CRC) and Sponsor responsibilities with regards to identifying, documenting and reporting AEs
  • Participants will be able to discuss how the Common Terminology Criteria for Adverse Events (CTCAE) is used for assessing AEs

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

The Role of the Lead Monitor and How to Become an Effective One

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

Identification: 313

Credits: None available.

Learn about the role of the Lead Monitor and take away tools and tricks for meeting the expected responsibilities and deliverables. Speakers will examine the characteristics, background, and experiences required of a Lead Monitor based on survey results from decision makers in the industry. Take away a solid understanding of the importance of building relationships with monitors and the study team, and of the importance of the Lead Monitor as a liaison between various functions.

Learning Objectives:

  • Participants will be able to know what characteristics makes a good lead monitor. What is senior management looking for in a monitor to take on the role of a lead monitor. Participants will learn tips on how to grow into the role of a lead monitor
  • Participants will become familiar with what are the responsibilities of a lead monitor. What are your deliverables
  • Participants will learn tips and techniques on how to build relationships with monitors, the study team and senior management. Speakers will share tips on creating tools on how to communicate the effectiveness of the monitoring function and how deliverables were met to the study team and senior management

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