SOCRA 2023 Annual Conference Brochure - Flipbook - Page 10
FRIDAY, SEPTEMBER 29, 2023
BREAKOUT SESSIONS
TRACK 1: BEHAVIORAL
HEALTH
1:15 to 2:00
Track: Behavioral Health
Managing, Measuring, Motivating Millennials and
Personnel To Promote Accountability and Personal
Satisfaction in Clinical Research Management
Clinical Research Personnel Management involves meeting
objectives and milestones while maintaining a productive
and motivated workforce. Ms. Wintering will discuss a
leadership approach that promotes personal performance
objectives that are aligned with the project objectives.
The speaker has learned much from working with
Millennials and Gen Z. Managing a multigenerational
workforce requires adaptation and flexibility which she
will share with the attendees.
There is an implicit expectation that work and interaction
in the workplace will be fulfilling. The importance of
learning and development in the context of enhancing
skills and professional development is key to retain
motivated staff. Topics to be presented will be developing
cross-training, promoting self-regulation and personal
accountability and strategies toward adapting the work
culture that can meet and measure performance while
supporting personal satisfaction with less demand for
managers. 109
Presenter: Nancy Wintering, MSW, LCSW, CCRP, Assistant
Director of Research, Thomas Jefferson University
2:05 to 2:50
Track: Behavioral Health
Statistical Model Considerations in Behavioral Health
Research
Mr. Gepty will address issues to consider when formulating
study designs and selecting appropriate statistical
models. Topics to be discussed include identifying
analytical approaches and models to match your
hypotheses, considerations of sample size, and choosing
the right statistical software. This talk will highlight
modern statistical methods to answer inferential questions
and will include intensive longitudinal models, multilevel
models, and handling missing data. 111
Presenter: Andrew Gepty, BA, MA, Doctoral Candidate,
George Washington University
9
TRACK 1:GCP + AUDIT
PREPAREDNESS
Time: 3:25 to 4:10
Track: GCP
Proper Documentation of a Clinical Trial: What are all
these forms and how do I complete them?
From Case Report Forms to Adverse Event, Deviation,
Screening-Enrollment, Delegation of Authority and IP
Accountability Logs, there is A LOT of information to be
recorded when documenting a clinical trial. Both new
and experienced study team members often have many
questions on ‘Best Research Practice’ when it comes to
filling out essential forms. When the regulations are
silent, IRBs, institutions, sponsors, CROs, and investigators
are free to develop their own procedures and practices
as long as applicable regulatory requirements are met.
However, certain elements should be taken into
consideration when determining how to record data with
integrity (reliable, accurate, complete, consistent,
trustworthy, in context). This talk will present background
information on WHY the forms are needed and guidance
on HOW best to complete them to comply with
regulations.“ 113
Presenter: Laura Adkins, MAP, CCRP, CCRA, CRS, AdvCRS,
Director, UAMS Office of Research Regulatory Affairs
Time: 4:15 to 5:00
Track: GCP
Informed Consent in Clinical Research: Getting it Right!
Ms. McAvoy will introduce Informed Consent in Clinical
Research starting with a brief historical overview of why
informed consent is important using examples (e.g.,
Nuremberg Trials). The speaker will describe what the
consenting process is, how to document it correctly,
special considerations, plus common errors and audit
findings related to the informed consent process.
Research Ethics Board requirements in the form of
templates and checklists will be covered, plus additional
topics such as assent, alterations/waivers to consent,
consent for secondary use of identifiable information,
and how email plays into the informed consent process.
Finally, Ms. McAvoy will provide some tips for writing
patient-centered informed consent forms. 115
Presenter: Elizabeth McAvoy, MA, CCRP, Associate
Director, Kingston General Health Research Institute