SOCRA 2023 Annual Conference Brochure - Flipbook - Page 7
THURSDAY, SEPTEMBER 28, 2023
PRECONFERENCE SEMINARS
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
Stacey Arnold, PhD, Results Team Subject Matter
Expert, ICF / National Institutes of Health (NIH)
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.
Presenter: Erin Krohl, MPH, MS, BS, President,
EHKrohl Consulting Inc.
SOCRA ANNUAL CONFERENCE BROCHURE
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 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
Wrenda Teeple, PharmD, Chief Clinical Officer and
Director of Regulatory Affairs, 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. Dr. George
D'Addamio will discuss the FDA’s regulatory
requirements and the ICH GCP guideline’s
standards for IRBs and current challenges facing
IRBs. 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.
Presenters: George D'Addamio, PhD, BS, MS,
President, PharmConsult Inc
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
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