ACRP 2018 Meeting & Expo

Apr 27, 2018 ‐ Apr 30, 2018



Sessions

FDA Inspections: Understanding the Process and Managing the Consequences

Apr 28, 2018 10:15am ‐ Apr 28, 2018 12:30pm

Identification: 100

Credits: None available.

This two-part "master series" program is designed for regulatory professionals who deal with complex issues, need to understand the latest developments, and can contribute their own front-line experiences for group discussion. In the first session, speakers will cover important Good Clinical Practice topics, and preparation for audits and regulatory inspections. The second session will employ hands-on activities to create corrective and preventive action plans utilizing root cause analysis procedures to address FDA citations in warning letters and 483s.

Learning Objectives:

  • Describe at least 3 regulatory actions FDA can take following an inspection
  • Discuss appropriate strategies for responding to inspection findings
  • Implement realistic and appropriate Corrective and Preventive Actions to successfully resolve inspection findings

Speaker(s):
  • Janet Holwell, CCRC, CCRA, FACRP, TIACR, Clinical Research Consultant, Independent Consultant
  • Glenda Guest, CCRA, RQAP-GCP, TIACR, Vice President, NCRA
Members: $25.00
Standard: $75.00

Technology and Innovation: Collaboration as the Key to Industry Transformation

Apr 28, 2018 10:15am ‐ Apr 28, 2018 11:15am

Identification: 111

Credits: None available.

"Alone we can do so little; together we can do so much." Harnessing the power of collaboration truly can alter the healthcare landscape as we know it today. This session will explore the how and why behind today's collaborations, and share perspectives around the next generation of collaborations. How will we need to work together differently? What may be the most surprising collaboration of the future? What new collaborations need to exist to defy the bounds of innovation and accelerate the prevention, diagnosis, treatment, and - ultimately - cures? This thought-provoking session will offer candid and innovative insight about what is needed to shake up the current ecosystem and truly transform patient health.

Learning Objectives:

  • Understand how collaboration is working today, and discuss how the ‘next generation of collaborations’ may be different
  • Share perspectives around whether collaborative R&D, pooling data and insights from academia, sponsors, and CROs is in our near future
  • Describe what roles the FDA, consortiums & associations, technology providers, and other stakeholders may have to play to enable collaborations of the future

Speaker(s):
  • Andy Lee, SVP, Head Global Clinical TrialOperations, Merck. Treasurer, TransCelerate, TransCelerate Biopharma Inc.
Members: $25.00
Standard: $75.00

Novel Techniques for Improving Subject Retention

Apr 28, 2018 10:15am ‐ Apr 28, 2018 11:15am

Identification: 112

Credits: None available.

Explore some of the many reasons more than 85% of clinical trials fail to retain enough patients. Speakers will present innovative approaches for improving subject retention and offer metrics demonstrating the impact of on-home and alternate site clinical services on patients, sites, and study sponsors. Take home strategies to immediately improve subject retention numbers.

Learning Objectives:

  • Recognize a few of the many reasons subject drop-outs occur
  • Identify innovative approaches for improving subject retention
  • Understand the impact in-home and alternate site clinical services can have on patients, sites, and study Sponsors

Speaker(s):
  • Nicki Norris, MBA, Chief Executive Officer, Symphony Clinical Research
Members: $25.00
Standard: $75.00

ACRP Certification Exam Prep: Part I

Apr 28, 2018 10:15am ‐ Apr 28, 2018 12:30pm

Identification: 113

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

Writing, Monitoring, and Documenting Protocol Deviations: Practical Tips

Apr 28, 2018 10:15am ‐ Apr 28, 2018 11:15am

Identification: 114

Credits: None available.

Master your understanding of protocol deviations, one of the most common problems identified in FDA inspections and the main reason for the rejection of data from a site or study. Speakers will address actions necessary when a deviation is found and the importance of all persons involved in clinical trials understanding deviations. Leave with a solid grasp of the characteristics of an evaluable subject, who can identify a protocol deviation, and methods for writing clear deviation descriptions.

Learning Objectives:

  • List the characteristics of an evaluable subject in a clinical research trial
  • Provide suggestions and clear examples for writing well-defined deviation descriptions
  • Identify study professionals who can a characterize and address protocol deviations

Speaker(s):
  • Sandra Hines, MS, CCRA, Project Manager, PRA Health Sciences
  • Annette Bernstein, MBA, CCRA, Sr. Manger, Quality Training Academy, Johnson & Johnson
Members: $25.00
Standard: $75.00

The Patient Voice: Improving Patient Experience by Understanding Patient Perspective

Apr 28, 2018 10:15am ‐ Apr 28, 2018 11:15am

Identification: 115

Credits: None available.

In a global survey conducted in conjunction with CISCRP, TransCelerate Biopharma, Inc. found that the vast majority (94%) of patients and caregivers felt that being aware of clinical trials conducted in their community was important. However, 79% of respondents reported being unaware of clinical trials for the condition they were most interested in. Explore how a consortium of leading biopharmaceutical companies has been utilizing this survey and other feedback mechanisms, such as Patient Advisory Boards, to further understand the patient perspective as it works to close this gap and design additional solutions to improve the patient experience. Insights from this global survey will be shared in parallel with what TransCelerate is doing to decrease patient burden, enable better-informed patients, and improve clinical research awareness, study participation, and engagement.

Learning Objectives:

  • Share key insights from a global survey conducted of 3,000+ global patients and caregivers around their perceptions of clinical trials, informed consent processes, electronic medicine labeling, and trial information sharing
  • Understand how patient feedback is being used to inform several key initiatives undertaken by TransCelerate BioPharma Inc., with a goal of improving the patient experience in clinical research
  • Describe best practices and learnings around how Patient Advisory Boards and other patient feedback channels can be utilized in the design of clinical trials and solutions

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

Overcoming the Barriers to Recruitment of Underrepresented Minorities

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

Identification: 122

Credits: None available.

Learn effective strategies for increasing clinical trial participation within underrepresented communities. The speaker will review data showing how racial and ethnic minorities are underrepresented in clinical research while addressing the rationale behind enactment of the National Institutes of Health Revitalization Act and its effect on minority enrollment in clinical trials. Leave with a strong understanding of the known barriers to recruiting underrepresented minorities and innovative approaches for improving recruitment and engagement within these populations.

Learning Objectives:

  • Understand the importance of minority participation in clinical research and identify some of the known barriers to recruitment
  • Understand the rationale behind the enactment of the NIH Revitalization Act and the effect it has had on minority enrollment in clinicl trials
  • Think of innovative ways to recruit minorities into clinical trials and engage their communities to create more diverse research participant populations

Speaker(s):
  • Stephanie Williams, MS, CCRC, Senior Regulatory Affairs Specialist, Cincinnati Children's Hospital
Members: $25.00
Standard: $75.00

Adverse Event Reporting in Medical Device Trials: Requirements from a Monitoring and Auditing Perspective

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

Identification: 123

Credits: None available.

Learn the ins and outs of adverse event (AE) reporting for medical device trials. Speakers will cover the differences between pharmaceutical and device AE reporting requirements, how to understand the AE reporting requirements for device trials based on the study protocol, and device AE reporting requirements from a monitoring and auditing mindset. Participate in an active discussion of AE requirements in 21CRF812 and 21CRF312, FDA’s current thinking on AE reporting in device trials and how this might impact which AEs are required to be reported, and how sites might need to delineate AE reporting between the protocol and their Institutional Review Board requirements. Hear several AE reporting case studies from monitoring and auditing perspectives.

Learning Objectives:

  • Understand the differences between adverse event (AE) reporting requirements under 21 CFR 812 vs. 312.
  • Determine appropriate AE reporting requirements for your medical device trial based on the study protocol.
  • Critically examine AE reporting requirements and processes for medical device trials, with a focus on monitoring and auditing perspectives.

Speaker(s):
  • Stephani Hulec, MS, CCRA, Associate Director of Clinical Monitoring Services, IMARC Research, Inc.
  • Michael Marotta, MS, Manager, Clinical Monitoring Services, IMARC Research Inc.
Members: $25.00
Standard: $75.00

A Change (Management) Would Do You Good

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

Identification: 124

Credits: None available.

Our industry doesn't have a great reputation for adapting to change. We can point to a variety of reasons why - we're risk averse, we're highly regulated, we prioritize conformity over creativity - but no matter how stubbornly we might resist, change is necessary and inevitable. Moreover, the scale and pace of change around us is unprecedented, driven by new technologies and increased pressure to produce better results more quickly. Many organizations are struggling to respond. Explore how change management practices can be incorporated into regular business operations to help clinical research organizations prepare for, adopt, and reinforce change. Speakers will present examples from a few high-impact changes their CRO underwent in the past 3 years and provide tools to take back and apply in your organization.

Learning Objectives:

  • Identify when a facilitated change management approach is needed
  • Understand the components of effective change management
  • Prepare for a large scale change management project

Speaker(s):
  • Pam Weppler, MA, PMP, CSSBB, Process and Change Program Leader, Rho
  • Ryan Bailey, MA, Senior Clinical Researcher, Rho
  • Karen Kesler, PhD, Assistant Vice President, Operations, Rho
Members: $25.00
Standard: $75.00

Developing a Clinical Research Education Program and Implementation Issues to Consider

Apr 28, 2018 10:15am ‐ Apr 28, 2018 12:30pm

Identification: 125

Credits: None available.

This interactive, two-part "master series" session is for small sites to large institutions wanting to develop or update their clinical research education programs. Speakers will provide tools, guidance, and some insider tips from the viewpoints of dedicated research sites and large, hospital-based research institutions on issues to consider during implementation. Leave with several takeaways to help develop or update your organization’s education program.

Learning Objectives:

  • Participants will review processes and tools to develop a clinical research education program
  • Participants will analyze implementation strategies for the program based on perspectives from a dedicated research site and a large research institution
  • Participants will develop and assess unique take-home plans for implementation in a workshop setting

Speaker(s):
  • Joshua Fedewa, MS, CIP, Associate Director, Human Research Protections Program, UT Southwestern Medical Center
  • Molly Downhour, MHA BSN NEA-BC OCN CCRC, Director of Strategic Solutions, Medix
  • Bridget Gonzales, CCRC, Director, Training and Professional Development, ACRP
Members: $25.00
Standard: $75.00