2024 Annual Conference Brochure - Flipbook - Page 7
THURSDAY, SEPTEMBER 26, 2024
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1:00 PM TO 5:15 PM
PRECONFERENCE SEMINARS
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 15 workshops on the following
topics:
CLINICALTRIALS.GOV ADMINISTRATION
Investigator-Initiated Sponsored Research
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
Why conduct investigator-initiated research? This workshop
will discuss the regulatory obligations of an IND/IDE sponsorinvestigator. Dr. Arbit and Dr. Teeple 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, RAC, CCRP, President and
CEO, Arbit Consulting, LLC
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
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. Speakers will discuss the FDA’s regulatory
requirements and the ICH GCP guideline’s standards for IRBs
and current challenges facing IRBs. Speakers will 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.
Presenters: Laura Holtz, MS, PMP, CCRP, Clinical Research
Associate, Yale School of Medicine - YCCI
Jessica Rowe, MA, MS, CIP, CCRP, Director, Quality and
Education, Yale Cancer Center Clinical Trials Office
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.
Presenter: Melissa Markley, JD, CISSP, Attorney / Shareholder,
Hall, Render, Killian, Heath & Lyman, LLP
SOCRA ANNUAL CONFERENCE BROCHURE
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