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.

The 2024 conference will offer 14 workshops on the following topics:

Preparing for the FDA Clinical Investigator Site Inspection
IRBs and the Informed Consent Process
Legal Issues Involving Researchers, Including Fraud and Misconduct
Clinical Research Administration, Budgeting, Contract Negotiation and Finance: A Site’s Perspective
GCP 101: A Workshop for the New Study Coordinator
Statistics in Clinical Research: Understanding Protocols and Statistical References
Device Research Regulatory Basics
Project Management & Process Standardization in Clinical Trials
Risk-Based Management - Principles and Practices for Successful Management of Clinical Research
SOP Development and Implementation
Investigator-Initiated Sponsored Research (IISR)
Optimal Study Start-Up Through Protocol Assessment
ClinicalTrials.gov Administration
Quality Management *NEW*

Preconference Workshop Overviews

ClinicalTrials.gov Administration

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.

Presenters:

Cristina Ferrazzano Yaussy, MPH, CCRP, Research Regulatory Affairs Specialist, Dartmouth-Hitchcock Medical Center

Preparing for the FDA Clinical Investigator 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 inspection. This workshop will educate the attendee in Good Clinical Practice (GCP) requirements and FDA inspection expectations, in order to aid in preparation for an FDA GCP inspection. 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 investigator? What makes FDA suspicious? Common FDA inspection findings at the clinical site; Specific examples of FDA-483 observations; FDA inspection strategy.

Presenter:

Jeannie Farnsworth, MS, BS, MRQA, CCRP, Regional Clinical Scientist, ICON

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.

Presenter:

Harvey Arbit, PharmD, MBA, RAC, CCRP, President and CEO, Arbit Consulting, LLC

IRBs and the Informed Consent Process

Initial and continuing ethical review by institutional review boards (IRBs), also referred to as independent ethics committees (IECs), and the informed consent process are the cornerstone for the protection of the human research subject. FDA regulations establish rules that clinical research professionals must follow during the clinical research process. The International Council on Harmonization (ICH) Good Clinical Practice (GCP) Guideline is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Laura Holtz and Jessica Rowe will discuss and explain the elements of a quality informed consent process under FDA regulations and ICH standards, and will also consider emerging challenges in obtaining informed consent. Lessons learned from experience and case studies will be presented for discussion.

Presenter:

Laura Holtz, MS, PMP, CCRP, Clinical Research Associate, Yale School of Medicine - YCCI
Jessica Rowe, MA, MS, CIP, CCRP, Associate Director, HRPP/YCCI, RCQ, Yale School of Medicine

Legal Issues Involving Researchers, Including Fraud and Misconduct

Traditionally research has been the one area in medicine where, other than the regulatory process, there has been little interaction with the legal system. However, in recent years this has changed. Within the U.S. and internationally there has been an increase in civil and criminal actions against researchers. This session will provide an overview of recent problem areas, as well as insight on how to avoid them.

Presenters:

Melissa Markey, JD, CISSP, Attorney / Shareholder, Hall Render
Carolina Wirth, JD, Counsel, Hall, Render, Killian, Heath & Lyman, PC

Clinical Research Administration, Budgeting, Contract Negotiation and Finance: A Site’s Perspective

This session will discuss the elements of a clinical trial protocol, budgeting and contracting, and the impact of these elements on the conduct of a trial. The administrative and financial aspects of the trial will be covered with special emphasis on the study administration, effective budget development and management and contract negotiations. This session will be interactive with participation from attendees to include developing and negotiating the study budget.

Presenters:

Bryan Soronson, MPA, FACMPE, Retired Senior Administrator, University of Maryland Department of Neurology
Lisa Benson, BS, CRCP, President, Pediatric Clinical Research Consulting, LLC

GCP 101: A Workshop for the New Study Coordinator

In an effort to enhance quality assurance at academic institutions, private practices or government-supported sites, SOCRA is offering a workshop for research personnel who are new to the field, or for those coordinators who want to refresh their understanding of GCP in the ever changing world of clinical research. This four-hour interactive workshop will include presentations, group discussion, and Q&A. The workshop will provide essential tools for coordinating and managing a research project. The material will range from understanding terminology to tackling a new project.

Presenter:

Tammy Neseth, MA, CCRP, Monitor

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

Risk-Based Management: Principles and Practices for Successful Management of Clinical Research

This workshop will introduce basic risk management principles and provide attendees the opportunity to understand how to use these principles for the successful management of clinical research. Typical research scenarios will be discussed, and attendees are invited to bring their own scenarios for group discussion.

Presenter:

Patricia Beers Block, MEd, BS, BS, Independent eClinical Consultant

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

We hope you will join us for this interactive program.

Presenters:

Kathi Durdon, BA, MA, CCRP, Executive Director, Central New York Biotech Accelerator
Angie Rock, MBA, CCRP, Director, Clinical Operations, BIOTRONIK, Inc

Project Management & Process Standardization in Clinical Trials

In the last few years, it has become more and more important to use solid project management principles in clinical trials. Process standardization is also important to ensure that clinical trials are run in the most efficient way possible with as much consistency used across similar studies as possible. This workshop will introduce users to an overview of project management principles following PMI guidelines, as well as an overview of basic process standardization techniques (using six sigma methodology) that will be relevant in clinical trials. Situational examples will be provided where possible.

Presenter:

Radhika Sivaramakrishna, PhD, PMP, CSSBB , CCRP, Consultant, Senior VP, Clinical Operations and Compliance at Quantum Leap Healthcare Collaborative

Quality Management * NEW

Quality management is a critical component of clinical trial operations. Effectively incorporating quality by design practices into research elevates the operational proficiently, compliance with the governing requirements, and protection of the participants. This pre-conference will illustrate the foundational components of quality management systems and focus on how to build and maintain a strategically designed quality assurance program.

Presenter:

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

Quality Improvement through Standard Operating Procedures (SOPs)

Standard Operating Procedures (SOPs) can be an effective tool to assist in the conduct of high quality clinical trials. This session will introduce, explain, and discuss fundamental concepts and current issues in the development and implementation of effective SOPs for the investigational site. Participants will discuss basic principles and current challenges regarding development, writing, and implementation of SOPs. This workshop consists of lectures, discussions, and interactive group exercises.

Presenter:

Donna Headlee, RN, BSN, CCRP, FDA Retired Branch Chief, PPB

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:

Jay Mandrekar, PhD, Professor of Biostatistics and Neurology, Mayo Clinic

senter: Stacey Arnold, PhD, Results Team Subject Matter Expert, ICF/NIH

Preconference Workshops

Thursday, 1:00 p.m. to 5:15 p.m.

Preconference Workshop Overviews

ClinicalTrials.gov Administration

Presenters:

Preparing for the FDA Clinical Investigator Site Inspection

Presenter:

Investigator-Initiated Sponsored Research (IISR)

Presenter:

IRBs and the Informed Consent Process

Presenter:

Legal Issues Involving Researchers, Including Fraud and Misconduct

Presenters:

Clinical Research Administration, Budgeting, Contract Negotiation and Finance: A Site’s Perspective

Presenters:

GCP 101: A Workshop for the New Study Coordinator

Presenter:

Optimal Study Start-Up Through Protocol Assessment

Presenter:

Risk-Based Management: Principles and Practices for Successful Management of Clinical Research

Presenter:

Device Research Regulatory Basics

Presenters:

Project Management & Process Standardization in Clinical Trials

Quality Management * NEW

Quality Improvement through Standard Operating Procedures (SOPs)

Presenter:

Statistics in Clinical Research: Understanding the Basic Concepts

Annual Conference