Preconference Workshop Seminars
Thursday, September 26 from 1:00 p.m. to 5:15 p.m.
The annual conference offers 14 Preconference workshops for those looking for in-depth education. The 2019 conference will offer 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
- The Ins and Outs of Publishing and Presenting Research Results with Pizzazz
- 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
Preconference Workshop Overviews
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 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 audit; Specific examples of FDA-483 observations; FDA inspection strategy.
Erin Krohl, MPH, MS, BS
EHKrohl Consulting Inc.
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.
Harvey Arbit, PharmD, MBA, CCRP
Arbit Consulting, LLC
Wrenda Teeple, PharmD
Senior Regulatory Affairs Specialist
Arbit Consulting, LLC
IRBs and the Informed Consent Process
Initial and continuing ethical review by institutional review boards (IRBs) or independent ethics committees (IECs) and the informed consent process are the cornerstones for protecting the human research subject. Regulations establish requirements clinical research professionals must follow, and the International Conference on Harmonization Good Clinical Practice Guideline provides guidance on complying with national or regional regulations. This session will review the regulatory requirements for IRBs and the informed consent process, challenges in obtaining informed consent, and challenges in keeping pace with technologically-evolving clinical research. Lessons learned from past experiences and regulatory enforcement actions taken to strengthen the systems for protecting the research subject will be discussed.
George D'Addamio, PhD
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.
Sheila Sokolowski, JD, BA
Hogan Marren Babbo & Rose, Ltd
Robyn Shapiro, JD
Attorney & Founder
Health Sciences Law Group
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.
Lisa Benson, BS, CCRP, CRCP
Senior Vice President Clinical Research Operations, Quality & Education
Institute of Advanced Clinical Trials for Children
Bryan Soronson, MPA, FACMPE, CRA
University of Maryland Deptartment of Neurology
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.
Sandhya Patel, BScN, BSc
Clinical Research Consultant
The Ins and Outs of Publishing and Presenting Research Results with Pizzazz
You (and your team) have worked hard. You have completed important research and are ready to share your results! But how can you share these facts in a clear and compelling manner? How do you figure out where to publish your work? How should the abstract be prepared to communicate succinctly and clearly, and successfully be published? How should a poster be formatted to visually grab the attention and interest of the viewer yet accurately convey results? And finally, how do you effectively and confidently present your research findings orally in an easy to understand confident manner at a seminar or similar forum? This workshop will answer these questions and furnish you with the tools, examples, and facts needed to accomplish these goals in a fun hands-on workshop format. Come learn with us!
Jason Jones, MS, BS, RAC, CCRP
VP North America, Clinical & Scientific Affairs
John Petrich, MS, RPh
Investigational Drug Service Manager
Cleveland Clinic Foundation
Richard Sloane, MS
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.
Janelle Allen, MS, BS, CCRP
Director, Clinical Research Operations, Quality & Education
Institute for Advanced Clinical Trials for Children
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.
Joanne Malia, BS, MS
Patricia Beers Block, MDEd, BS, BS, CCRP
Rutgers the State University of New Jersey
Device Research Regulatory Basics
This engaging workshop is all about medical devices – we may talk a little about pharmaceuticals, but only when comparing differences. Who should attend this workshop? If you are new to conducting medical device studies, or maybe you work for a startup company and need to know how to get your product cleared or approved for market – you might want to attend this workshop. Or you work in a clinical research, regulatory or quality affairs department – you might want to attend this workshop. You could be a study coordinator, study monitor, research nurse, statistician, data manager or principal investigator and have an interest in medical device research – you might want to attend this workshop. You may want a refresher on topics specific to medical device to include compliance with Good Clinical Practice (GCP) regulations, non-significant risk and significant risk studies, risk management, investigator initiated studies, monitoring process, human factors engineering integration and usability testing – you might want to attend this workshop. We’ll generate active discussion in challenging areas, promote examples through case studies, and provide a comprehensive overview of medical device research and regulations.
Kathi Durdon, BA, MA, CCRP
CNY Biotech Accelerator, SUNY Upstate Medical University
Angela Rock, MBA, CCRP
Senior Manager, CRA Group
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.
Radhika Sivaramakrishna, PhD, PMP, CSSBB, CCRP
Executive Director, Clinical Operations and Project Management
SOP Development and Implementation
This workshop will discuss fundamental concepts and current issues in the development and implementation of an effective Standard Operating Procedure (SOP) program for clinical sites. Basic principles, as well as challenges, will be introduced through lecture, discussion and “hands-on” exercises. Critical information will be presented and discussed including investigational site best business practices, the necessity for SOPs, SOP development, prioritizing SOPs, and implementing SOPs at the investigational site. Techniques for writing effective SOPs will be discussed and participants will develop a relevant investigational site SOP. Additionally strategies for SOP approval processes, tracking SOPs, and development of a training program and continuous process improvement plan will be presented.
Donna Headlee, RN, BSN, CCRP
The contents of this presentation are my own, and do not necessarily reflect the views and/or politics of the FDA or its staff. The FDA will not be bound by any of the comments in this presentation.
Statistics in Clinical Research: Understanding Protocols and Statistical References
Do you skip over the statistical section of protocols? Does the thought of having to explain why certain analyses are going to be performed on your study make you wish you could crawl into a hole? If so, you are not alone. This very practical section is designed to be a low-stress, non-intimidating, entertaining, and fun (yes fun!) way to understand what the statistical terms in a protocol really mean. No equations and no math! This course is designed simply to understand the basic concepts. This session will aid participants in understanding statistical references used in various protocols, reviewing how statistics are used to determine clinical trial outcomes, and will discuss how what is entered (or not entered) on a CRF can change the outcome of a clinical trial.
Mark Krailo, PhD
Professor, Department of Preventive Medicine
University of Southern California
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.
Stacey Arnold, PhD
Results Team Subject Matter Expert
Cristina Ferrazzano Yaussy, MPH, CCRP
Vice President of Professional Services
Dartmouth-Hitchcock Medical Center