SOCRA 2023 Annual Conference Brochure - Flipbook - Page 19
SATURDAY, SEPTEMBER 30, 2023
BREAKOUT SESSIONS
TRACK 4: QUALITY
MANAGEMENT
Time:3:45 to 4:30
Track: Quality Management
Analysis of Quality Challenges in Phase I and II in
Cellular and Gene Therapies
Dr. Soans will compare quality challenges seen in FDA
approved cellular and gene therapies in the market to
early phase development products at St. Jude. We will
look at how we have responded to FDA Information
requests on quality and time taken from pre-IND stages
to IND submissions and what have been the limitations..
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Presenter: Eroica Soans, PhD, CCRA, Senior Medical
Writer, St Jude Children's Research Hospital
TRACK 5: SITE MANAGEMENT
Time: 8:30 to 9:15
Track: Site Management
How to Build a Robust Student Research Training
Program
Ms. Jones will initiate a discussion that goes step by step
into how to build a volunteer student research training
program from recruitment, curriculum, and support to
research projects. We will discuss how to set up
mentorship and support for a mutually beneficial
experience as a direct feed into positions at your
institution and to support studies with limited financial
resources. 517
Presenter: Laura Jones, BA, CCRP, IRB Principal Analyst,
UC San Diego
Time: 9:20 to 10:05
Track: Site Management
What is it Really Like Switching from Paper to
eRegulatory.
How does the transformation work? How long does it
take? What can you do to make it most effective as a
tool? What are the positives and pitfalls? In the end, is
it really worth the cost and effort? 519
Presenter: Mark Sulik, PharmD, CCRP, Director of Clinical
Research, Rocky Mountain Diabetes Center
Time: 10:50 to 11:35
Track: Site Management
Leading with Purpose - How to Build and Maintain a
Resilient Clinical Research Team
Ms. Wentzel has been leading a multi-dimensional
clinical research team for over 25 years. She will share
lessons learned as well as strategies and tactics for
interviewing, team-cohesiveness and, most importantly,
retention. 521
Presenter: Grace Wentzel, BA, CCRP, CHRC, Executive
Director, Site Operations, Javara Research
SOCRA ANNUAL CONFERENCE BROCHURE
TRACK 5: SITE MANAGEMENT
Time: 11:40 to 12:25
Track: Site Management
Good Clinical Practice in an Electronic-Based Records
System
Good clinical practice (GCP) is an international ethical
and scientific quality standard for designing, recording,
and reporting trials that involve the participation of
human subjects. GCP principles help assure the safety,
integrity, and quality of clinical trials by addressing
elements related to the design, conduct, and reporting
of clinical trials.
Electronic-Based records systems are being increasingly
used in the conduct of clinical research. They enable the
capability to streamline data transfer, remote
enrollment capabilities, greater transparency of the trial
conduct, improved research documentation, clearer
audit trails and to solve the challenges of physical
document storage constraints at trial sites.
From a monitoring perspective, Ms. Wright will discuss
the basics of GCP in an electronic-based records
system, highlight the importance of a culture of total
quality, how to identify challenges, as well as offer
solutions for good recordkeeping practices. Examples
will be provided. 523
Presenter: Alicia Wright, MS, CCRP, Clinical Research
Associate III, Vanderbilt University Medical Center
TRACK 5: STUDY START UP
Time: 1:40 to 2:25
Track: Study Start-up
Compliance in Regulatory Start Up: Tips and Tricks to
Expedite Study Start Up (from a site perspective)
Everyone wants study start up to be both accurate and
speedy. Ms. Gruetzmacher will go over essential areas
of study start up from a site perspective, and how to
quickly and accurately get trials ready for enrollment.
Some of the items to be discussed include what needs to
go on a 1572, which documents to ask staff for, tips and
tricks gleaned from HHS emails/FAQs, delegation logs,
what trainings are needed and how to document
training, what is needed for an IRB submission, what
should be submitted, scheduling site initiation visits,
investigator meetings, and so much more. 525
Presenter: Crystal Gruetzmacher, CCRC, CHRC, Clinical
Research Coordinator, Monument Health Clinical
Research
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