ACRP 2019 OnDemand

Apr 12, 2019 ‐ Apr 15, 2019



Sessions

Evolution of the Clinical Research Workforce for the Future

Apr 13, 2019 8:00am ‐ Apr 13, 2019 9:00am

Identification: 5022

Credits: None available.

Speaker(s):
  • Jim Kremidas, Executive Director, ACRP
  • Andy Lee, SVP, Head Global Clinical TrialOperations, Merck. Treasurer, TransCelerate, TransCelerate Biopharma Inc.
  • Virginia Nido, BA, MSeD, Global Head, Industry Collaborations, Genentech
  • Donald A. Deieso, PhD, Executive Chairman & Chief Executive Officer , WCG
Members: $15.00
Non Member: $75.00

How to Create a Culture of Quality at a Research Site

Apr 13, 2019 10:15am ‐ Apr 13, 2019 11:15am

Identification: 116

Credits: None available.

Sites are busy and often overlook quality assurance (QA) and only focus on QA when issues arise or when faced with an audit. This presentation will describe our experience creating a culture of quality using an integrative approach in a team environment. Our techniques are easy to implement and include quality assurance checks, office guidelines, checklists and lessons learned. We will discuss the challenges of implementing a quality management system and how to overcome setbacks.

Learning Objectives:

  • After the presentation, participants will be able to take ownership of their culture of quality using practical tools and advice. Participants will have practical tools to help their site own quality.
  • Participants would better understand quality assurance and its challenges.
  • Participants will be able to use info presented to implement site quality management system.

Speaker(s):
  • Sergey Nikitin, BSc, MBA, President and Director, Prime Site Research Solutions Inc.
  • Jessica Pinder, BSc, CCRP, PMP, Project Manager, Prime Site Research Solutions Inc.
Non Member: $75.00
Members: $15.00

Applying Six-Sigma Tools and Concepts to Your Clinical Research Activities

Apr 13, 2019 10:15am ‐ Apr 13, 2019 12:15pm

Identification: 119

Credits: None available.

Six Sigma is a certification that can be achieved but it's also concepts and practices to apply to everyday activities. The way regulated processes, documents and work practices are handled and executed offer opportunities on a daily basis.

Learning Objectives:

  •  Recognize and understand the concepts of Lean Six Sigma.
  •  Identify key questions to consider when determining if a process is lean.
  •  List specific actions to lean the document management processes.

Speaker(s):
Members: $15.00
Non Member: $75.00

Integrating Quality into Investigator-Initiated Clinical Trials

Apr 13, 2019 10:15am ‐ Apr 13, 2019 11:15am

Identification: 157

Credits: None available.

There are many steps that must be taken to assess risk and integrate quality when developing, initiating and conducting a clinical trial. These steps are crucial for every type of clinical trial. This session will describe how to apply those principles to investigator-initiated clinical trials utilizing tips, tools and templates available to help along the way.

Learning Objectives:

  • Identify quality standards, and areas of risk, for clinical trials.
  • Describe measures to incorporate quality into study design and initiation of Investigator-Initiated Trials (IITs).
  • Examine ways to assess quality during IIT study conduct.

Speaker(s):
  • Neala Lane, MS, CCRC, Associate Director, Quality Improvement Office, Indiana University
Members: $15.00
Non Member: $75.00

Building Relationships & Collaboration: Sponsors and Sites

Apr 13, 2019 10:15am ‐ Apr 13, 2019 11:15am

Identification: 166

Credits: None available.

How would you describe your CRC-CRA relationship? Do you see opportunities to increase your communication and collaboration? Then this session is for you!

We invite all CRCs, CRAs and site personnel to join this session for a review and discussion of these relationships. Feedback from high performing sites on strategies for collaboration and relationship building will be shared and discussed.

  • Identify the expectations of CRAs.
  • Identify the expectations of CRCs based on feedback from active sites.
  • Identify skills and provide tips to improve this relationship.

Speaker(s):
Non Member: $75.00
Members: $15.00

Getting Multicenter Studies Under Control with Technology

Apr 13, 2019 10:15am ‐ Apr 13, 2019 11:15am

Identification: 225

Credits: None available.

You’ve just been handed a project: An investigator-initiated study with 20 sites on a tight deadline, and here’s the kicker: It’s up to your small team to manage it on top of all your other work. The three panelists before you have all faced this situation… and triumphed. In this session, learn how they did it. Topics explored include: • Strategic approaches to spread work equitably across study teams • Tips for the most critical phases of your study: Startup, monitoring/QC, ongoing communications and closeout In house tools that give you the leverage to “build it once, use it lots” • Purpose-built tools that enable secure collaboration of documents and tasks • What I’d do differently next time: Learn from our mistakes.

Learning Objectives:

  • Launch a multi-center study using a lean team.
  • Get buy-in on use of new technologies.
  • Improve GCP through remote oversight.

Speaker(s):
  • Ryan Jones, MBA, CEO, Florence Healthcare
  • Melissa Bolton, MBA, CCRC, Clinical Project Manager, University of Utah, Department of Pediatrics
  • Jessica Rodriguez, PhD, CCRP, Research Program Coordinator at Mount Sinai Health System, Department of Neurosurgery- Mount Sinai Health System
Non Member: $75.00
Members: $15.00

EFS is the new OUS strategy for early-phased medical device clinical trials

Apr 13, 2019 10:15am ‐ Apr 13, 2019 11:15am

Identification: 232

Credits: None available.

This session will provide the participant with several real-world examples of the benefits and risks of conducting early-phased medical device clinical trials, and the strategies involved in optimizing this avenue fo regulatory submissions. The participant will obtain tools to develop successful clinical and regulatory strategies for new devices and indications.

Learning Objectives:

  • Define FDA's Early Feasibility Study (EFS) Program.
  • Outline the risks/benefits of participating in the EFS program for early-phased clinical trials.
  • Outline strategies to leverage EFS protocols for PMA and 510 submissions.

Speaker(s):
  • Christopher Cain, CCRA, RAC, VP, Clinical and Regulatory Affairs, Conformal Medical, Inc.
  • Victor Chen, Director, Clinical Affairs, Align Technology
  • Maureen Dreher, Ph.D, Policy Analyst, Clinical Trials Program, US Food and Drug Administration, Center for Devices & Radiological Health
Members: $15.00
Non Member: $75.00

Post-ICH GCP E6 R2: Institution/Investigator Qualification and Oversight of External Parties in Clinical Trials

Apr 13, 2019 10:15am ‐ Apr 13, 2019 12:15pm

Identification: 243

Credits: None available.

Since the publication and global implementation of ICH GCP E6 R2, Institutions and Investigators are grappling with the appropriate and adequate approaches for qualifying external parties (e.g., testing facilities [clinical laboratories, radiology centers, medical specialists [ophthalmologist]) and implementing oversight of delegated trial-related duties, functions, activities and tasks. This session reviews the requirements and includes a panel discussion with experts in institutional research administration, operations and compliance, GCP compliance and a clinical investigator on how to implement the requirements, and how the sponsor/CRO Study Managers and Site Monitors are to monitor and manage the investigator/site.

Learning Objectives:

  • Evaluate external parties responsibilities and contributions to the study in order to accurately design and implement investigator supervision and oversight of the work performed and data generated for the trial.
  • Discuss the Investigator/Institution ICH GCP E6 R2 requirements for the qualification and oversight of an individual/party (external parties).
  • Analyze healthcare organization qualification standards and approaches for both a facility and medical practitioners to leverage in clinical research for the ICH GCP E6 R2 requirements.

Speaker(s):
  • Liz Wool, F-ACRP, CCRA, CID, CMT, BSN, Chief Learning Strategist, Virtual Training WHIZ, Workforce Development Practice Lead, Wool Consulting Group Inc.
  • Erika Stevens, BA, MA, Principal Consultant, Recherche Transformation Rapide
  • Lionel Lewis, MA, MBBCh, MD, Co-Director of the Clinical Pharmacology Resource, The Geisel School of Medicine at Dartmouth & Dartmouth-Hitchcock Medical Center
Non Member: $75.00
Members: $15.00

Knock, Knock....FDA is here; Be Prepared for a Regulatory Inspection

Apr 13, 2019 10:15am ‐ Apr 13, 2019 11:15am

Identification: 5015

Credits: None available.

What do you do when a regulatory Agency knocks on the door? Turn off the lights? Panic? If you’re prepared, it should be an exercise to ensure your systems are working the way you designed them. We will briefly look at FDA Inspections and how to prepare for the inevitable knock, and discuss resources available to you.

Learning Objectives:

  • Learn how to prepare for a regulatory inspection, before the “knock on the door”.
  • Learn what should be in your quality system to be prepared.
  • Understand what resources are available for you prior to, during, and after regulatory inspections.

Speaker(s):
  • Eric Pittman, MBA, Program Division Director, U.S. Food and Drug Administration
Non Member: $75.00
Members: $15.00

The Missing Links in CRA Training...How Do We Fix the Chain?

Apr 13, 2019 11:30am ‐ Apr 13, 2019 12:30pm

Identification: 111

Credits: None available.

This session will examine the most frequent errors witnessed at a study site due to lack of/poor training on the part of the Clinical Research Associate. Training tips and remediation ideas along with a comprehensive dialogue on how to improve training will be presented. Session participants will be asked to share their viewpoints and experiences as to what they have seen and implemented at their study sites.

Learning Objectives:

  • List the most common oversights encountered at a study site due to a lack of adequate CRA (Clinical Research Associate) training.
  • Identify solutions and training tips for filling in the training gaps to ensure compliance and decrease the ‘slip-ups’.
  • Discuss with session attendees what is currently ‘working’ and what is ‘not working’ on the training forefront at their study sites.

Speaker(s):
  • Annette Bernstein, MBA, CCRA, Senior Training Manager, Johnson & Johnson
  • Sandra Hines, MS, CCRA, Project Manager – Strategic Solutions PRA Health Sciences , Janssen Neuroscience
Non Member: $75.00
Members: $15.00