Preconference Workshops
Thursday, 1:00 p.m. to 5:15 p.m.
Maximize your conference experience by registering to attend a half day preconference workshop prior to the main conference. Subject-matter experts will delve into project management, GCP 101, risk management, budgeting and more.
To register for a pre-con workshop only CLICK HERE
Preconference Workshop Overviews
ClinicalTrials.gov: What Administrators Need to Know
Are you involved in the registration, management, and results entry of studies in the Protocol Registration and Results System (PRS)? Are you struggling with how to start and where to go for help? The workshop will review PRS Administrator responsibilities, lessons learned from moving an existing program toward a positive direction, and provide guidance for managing trials, in addition to reviewing the registration and results entry process. Best practices and helpful tips for both Administrators and users will be provided. Attendees are invited to bring their own scenarios for group discussion and should leave the workshop with skills to successfully manage trials within ClinicalTrials.gov.
Presenter:
Cristina Ferrazzano Yaussy, MPH, CCRP, Research Regulatory Affairs Specialist, Dartmouth-Hitchcock Medical Center
Investigator-Initiated Sponsored Research (IISR)
Why conduct investigator-initiated research? This workshop will discuss the regulatory obligations of an IND/IDE sponsor-investigator. Dr. Arbit will describe the resources needed to support and the risks associated with conducting investigator-initiated clinical trials. The participants will learn how to determine if a sponsor-investigator IND or IDE is needed. There will be ample opportunity for discussion and Q&A.
Presenters:
Harvey Arbit, PharmD, MBA, RAC, CCRP, Founder and Consulting Partner, Arbit Consulting, LLC
Wrenda Teeple, PharmD, MBA, RAC, CCRP, President, Arbit Consulting, LLC
Budgeting, Contract Negotiation, and Finance
This budgeting workshop will focus on effective budgeting strategies to ensure success in increasing your bottom line by aligning best practices and tactics. Participants will learn how to identify internal costs, justify their budget requests, allocate resources efficiently, ensure concise contract language, and prioritize funding while making informed financial decisions to support research goals; all while improving financial transparency and adhering to compliance requirements.
Presenters:
Dawn Pittinger, DBA, MBA-HA, CHRC, CCP, CHC, CHA, Director of Research Compliance, Nemours Children's Health
Candida Barlow, Director of Clinical Research and Assistant Professor of Nursing, Oklahoma State University
Optimal Study Start-Up Through Protocol Assessment
This workshop, for coordinators, research nurses, clinical research managers, and program managers - with more than 5 years of experience, will demonstrate how to dissect a protocol to determine protocol requirements and to illuminate protocol needs. Once the protocol has been thoroughly analyzed, we will demonstrate methods and tools that will prepare the site for clinical trial success. Discussions will pertain to necessary considerations prior to study start-up. Attendees should leave the workshop with skills to ideally organize their sites for continued success in clinical trials.
Presenter:
Janelle Allen, MS, BS, CCRP, Professional Consultant & Corporate Trainer, Faculty at Miami University
Device Research Regulatory Basics
This engaging workshop is all about medical devices – we may talk a little about pharmaceuticals, but only when comparing differences. All interested in medical device research and regulations are welcome.
What we will cover:
• Medical device terminology
• Medical device regulations including device classification and regulatory submission
• Clinical investigations and the Investigational Device Exemption (IDE)
• Study monitoring for medical device
• Case Study Review
Presenters:
Kathi Durdon, BA, MA, CCRP, Executive Director, Central New York Biotech Accelerator
Angie Rock, MBA, CCRP, Director, Clinical Operations, BIOTRONIK, Inc
Quality Management
Quality management is a critical component of clinical trial operations. Effectively incorporating quality by design (QbD) practices into research elevates the operational proficiently, compliance with the governing requirements, and protection of the participants. This pre-conference, which incorporates the QbD strategies emphasized by the newly published ICH GCP E6 (R3), will illustrate the foundational components of quality management systems and focus on how to build and maintain a strategically designed quality assurance program. By the end of the program, attendees will be able to:
- Discuss the foundational components of risk management and quality management systems in clinical research
- Describe the best practices that support highly effective quality programs
- Provide didactic training, which can be used to acquire specific skills related to clinical trial quality management activities
Presenters:
Abby Statler, PhD, MPH, MA, CCRP, Director, Research Quality & Safety, Dartmouth Health
Alyssa K. Gateman, MPH CCRP, Executive Director, Yale Cancer Center Clinical Trials Office
Statistics in Clinical Research: Understanding the Basic Concepts
An introduction to essential statistical concepts in clinical research will be presented in this workshop. No pre-requisite of extensive statistical background or experience in clinical research is required! The different components of a research protocol and multiple steps required from start to finish of a clinical trial will be presented in an easy-to-understand format. These include designing the study, proposing research aims and outcomes, understanding the importance of various types of randomization schemes, deciding on data collections tools and setting up electronic databases, patient recruitment and engagement, sample size estimation, statistical analysis plan and much more! The concepts will be presented using real life examples of clinical studies from diverse clinical areas.
Presenter:
Mark Krailo, PhD, Senior Statistician Emeritus, Children's Oncology Group and Kenneth Norris Jr Cancer Center and Research Institute, University of Southern California
Clinical Trial Documentation: Best Practices for Compliance and Organization
(Taught in Spanish)
Clinical coordinators and research staff will receive an overview of the organization and management of essential study documentation. Learn about the importance of audit and inspection preparation. Explore options for ensuring the proper retention of documentation in accordance with clinical research standards and regulations.
(Coordinadores clínicos y personal de investigación recibirán una visión general de la organización y gestión de la documentación esencial del estudio. Aprender sobre la importancia de la preparación para auditorías e inspecciones. Explorar opciones para la garantía de la retención adecuada de la documentación de acuerdo con la normativa y regulaciones de investigaciones clínicas.)
Presenters:
Di Pereira, BS, MBA, CCRP, Principal, Alcon
Julissa Alvarez, MD, EdD, CPH, Clinical Research Manager, Envision Healthcare
Foundations of Clinical Research Project Management
Clinical trials are complex, resource-intensive, and highly regulated. Applying structured project management principles and standardizing processes are critical to ensuring efficiency, compliance, and quality. This interactive workshop introduces project management fundamentals following PMI’s methodologies and explores how Six Sigma and Lean Six Sigma concepts can support process standardization in clinical research. Through case-based discussions, team activities, and hands-on practice with real-world templates, participants will gain both conceptual knowledge and practical tools they can immediately implement in their own work.
Presenters:
Jessica Thompson, MS, MBA, PMP, Chief Visionary Officer, Clinical Research Pro
Amy Selegue, BA, BSN, MLS, CCRP, Course Instructor/Consultant, Clinical Research Pro
Preparing for the FDA Clinical Investigation Site Inspection
This workshop will address Food and Drug Administration (FDA) perspectives and the regulations regarding adherence to protocol, records management, patient rights, drug / product management and record keeping, and regulatory issues related to an FDA audit. This workshop will educate the attendee in Good Clinical Practice (GCP) requirements and FDA audit expectations, in order to aid in preparation for an FDA GCP audit. This interactive workshop will provide the following: A brief introduction to the FDA; Overview of clinical research, including the Federal Regulations covering clinical research and clinical investigator obligations; Discussion on Trial Site Roles and Responsibilities; Explanation of the FDA’s Bioresearch Monitoring Program, focusing on the Clinical Investigator inspection; Insight on understanding the FDA GCP inspection: Who is the FDA auditor? What makes FDA suspicious? Common FDA inspection findings at the clinical site, specific examples of FDA-483 observations, and FDA inspection strategy.
Presenter:
Tammy Neseth, MA, CCRP, Senior Manager Site Services for Quantum Leap Healthcare Collaborative