NYS SOCRA Chapter Summer Program
7:45 a.m. – 3:45 p.m.
The Lodge, 4355 State Street Rd, Skaneateles Falls, NY
Agenda
7:45 a.m. Sign-In, Continental Breakfast and Networking
8:15 a.m. Welcome and Introduction
8:20 – 9:10
What Does the FDA Have to Do with It? Understanding Devices in Human Subject Research
Rebecca Dahl, PhD, CIP, Assistant Vice President Research Compliance, Stony Brook University
This session will explore the various types of device pathways and the Food and Drug Administration regulations as they pertain to the use of devices in human subject research.
9:10 – 10:00
Sponsor Site Selection Criteria and Process
Paul Felckowski, Expert Clinical Research Associate, Novartis
Speaker will discuss the sponsor site selection process – what do they look for and what can set your site apart. Included topics are the focus of feasibility and site selection, who is involved in site selection and what are they looking at. The speaker will also discuss remote data review and risk-based monitoring at a glance.
10:00 – 10:20 Quick Beverage Break
10:20 – 11:20
From the Research Bench to the Universal Infant Immunization Schedule: Step by step from basic science discoveries in 2014 to a safe and effective immunization for the prevention of infant RSV infection in 2023
Joseph Domachowske, MD, FAAP, FPIDS, Professor of Pediatrics, Professor of Microbiology and Immunology, Department of Pediatrics, SUNY Upstate Medical University
This presentation will include an overview of Respiratory Syncytial Virus (RSV). RSV is the leading cause of infant and young childhood hospitalization and the path towards a vaccine to prevent it to include a description of the clinical trials performed to collect evidence to support approval. Dr. Domachowske will also describe expectations going forward to include a complete change in the landscape of infant RSV infection.
11:20 – 12:10
Enrollment and Retention Concerns and Mitigations in Longitudinal Clinical Trials
Scott Wehage, MS, CCRP, Director, Clinical and Rural Health, St. Lawrence Health
We will review enrollment and retention practices, challenges and pitfalls and mitigations for large, multi-site, longitudinal studies. We will review real life mitigation strategies that work!
12:10 – 1:10 Lunch and Networking
1:10 – 2:00
The Virtue Ethics of Informed Consent for Nationwide, Multicenter Clinical Trials
Alexander Montes, PhD, Post-doctoral Associate, University of Rochester
In this presentation, I argue that virtues such as care, respectfulness, and humility are fundamental to the process of obtaining informed consent for clinical trials, particularly with regard to large multicenter clinical trials that recruit from diverse populations across the nation (or across multiple nations). Studies have found that potential participants often misunderstand what they are consenting to, a problem exacerbated by long, jargon filled consent documents. I will argue that virtues ought to play a fundamental role in the informed consent process in order to help mitigate this problem. Virtues are fundamental because virtues provide us with rich descriptions of not only what we should do (respect autonomy) but how to do so (with the virtues of respectfulness, care, humility, etc.). A focus on virtues can correct the short sightedness of a focus solely on following rules, regulations, and guidelines.
2:00 – 2:50
Quality Management
Jessica Rowe, MA, MS, CCRP, CIP, Associate Director, Yale Human Research Protection Program, Office of Research Administration, Yale School of Medicine, Yale Center for Clinical Investigation
During this presentation Ms. Rowe will discuss the essential components of a quality management program. The presentation will focus on quality control and quality assurance strategies for the site. In addition, inspection/audit readiness will be discussed within the context of a strong quality management program.
2:50 – 3:40
Statistical / Data Science Methods in Clinical Research
Thomas T. John, PhD, Assistant Teaching Professor, Department of Mathematics, Syracuse University
This presentation will go through some typical statistical analyses used in scientific research, in particular clinical research, as well as the results of such analyses typically presented in current clinical/medical journals. Using some actual health related datasets, analyses examples will be carried out live, including graphical visualization of the data. Along with the interpretations of the analyses, the discussion will include some of the related nuances that researchers collecting and recording data should keep in mind.
3:40 – 3:45 Final Comments
The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area.
This program will provide 6.17 hours of continuing education hours. Program is in-person attendance only. This program will not be recorded.
Please send completed On-site Registration Form by July 4 to: durdonk@upstate.edu
As SOCRA Chapters are not allowed to accept any funds/payments, all catering fees must be paid directly to the catering vendor:
- Payment of the $ 43.00 catering fee is expected the day of the program. Please plan to pay by credit card or check. If paying by check – make checks payable to “Eurest Dining Services.”
- If you need to send your check in advance, checks payable to “Eurest Dining Services” can be mailed to: The Lodge Skaneateles, 4355 State Street Rd., Skaneateles Falls, NY 13153, Re: SOCRA Chapter Program.
- The Lodge Skaneateles requests we provide our final guest count at least ten calendar days prior to the date of Event. On-site registration form must be sent by July 4 to: durdonk@upstate.edu.