Upstate Medical University

Clinical Research Program, The Lodge, Skaneateles Falls, NY

New York State SOCRA Chapter Clinical Research Program
Open to the Public
Friday, October 14, 7:45 a.m. – 3:30 p.m.

The Lodge Skaneateles, 4355 State Street Rd, Skaneateles Falls, NY

In Person Attendance:  Send On-site Registration Form to:  durdonk@upstate.edu

Virtual Attendance:  https://upstate.zoom.us/meeting/register/tJAsc-2tqz0oE91ZS9HWZhJ5U1U5CXVJMOe5

 

7:45 a.m.                    Sign-In, Continental Breakfast and Networking

8:15 a.m.                    Welcome and Introduction

8:20 – 9:10                
Choosing the Right Outcomes for Clinical Research
Katie Piston, PhD, Manager, Medical Affairs, Baxter
When designing and executing clinical research, choosing the correct outcomes is critical.  In this talk we will discuss the importance of designing that tests the correct outcome and implications it has on the study timeline, generalizability, significance and budget.

9:10 – 10:00              
Pre-clinical Research to Evaluate Therapeutics, Drugs and Vaccines against Emerging Infections in a Biosafety Level-3 (BSL-3) Laboratory
Saravanan Thangamani, PhD, 
Professor, Department of Microbiology and Immunology; Director, SUNY Center for Vector-Borne Diseases; Director, Vector Biocontainment Laboratories; Institute for Global Health & Translational Sciences, SUNY Upstate Medical University
The Vector Biocontainment Laboratory [VBL] at Upstate Medical University facilitates research on infectious diseases that are classified as significant public health threats, such as COVID-19, Lyme disease, West Nile encephalitis, zika virus disease, chikungunya virus disease, dengue fever, malaria, Powassan encephalitis and other emerging infectious diseases at different biocontainment levels (BSL-2, ABSL-2, ACL-2, BSL-3, ACL-3, and ABSL-3). In this presentation, I will discuss our pre-clinical research capacity to evaluate therapeutics, drugs, and vaccines against emerging infections.

10:00 – 10:20            Quick Beverage Break                                             

10:20 – 11:05           
Recruiting Patients and Community Members into Clinical Research: Utilization of MyChart and Facebook
Carrie Dykes, Director of Research Services, Clinical Translational Science Institute, University of Rochester
The University of Rochester Clinical and Translational Science Institute provides participant recruitment and retention consultations to investigators.  Recently the UR CTSI implemented the utilization of MyChart messaging for research and Facebook advertising to recruit from the community.  The presenter will provide information that should be considered by organizations who want to develop these services and will provide information on how they have performed.

11:05 – 12:00           
Using Metrics in a Research Quality Program
Kathleen Wessman, RN, MPA, RQAP-GCP, CCRC, Director, Research Quality Improvement; Jennifer Dolan, MS, LMT, CCRC, Specialist, Research Quality Improvement; Elizabeth Lyda, BS, RRT, Specialist, Research Quality Improvement, Office for Human Subject Protection, University of Rochester
As research monitoring and compliance paradigms evolve, human subject research teams are challenged to ensure quality in research maintains or exceeds expectations and standards. In this session, participants will be able to:

  • Observe the REDCap program in a research compliance program
  • Assess, evaluate, and analyze high-risk findings in human subject research
  • Identify metrics to support compliance throughout the human research protection program

12:00 – 1:00              
The Lodge Lunch and Networking 

1:00 – 1:50                
Human Subject Recruitment
Amanda Goodhines, Test Engineer II, Baxter
Presenter will identify obstacles to recruiting for human subject testing, discuss why they exist and review the opportunities to overcome these obstacles.

1:50 – 2:40                
Memorial Sloan Kettering Virtual Monitoring and Auditing Digitization in Decentralized Clinical Trials: System Scheduling, Source Document Verification, and Real Time Protocol Performance Feedback (Virtual Presentation)
Karima Yataghene, M.D., Director, Clinical Research Quality Assurance (CRQA) and Mike Buckley, Clinical Research IT Enterprise Innovation, Memorial Sloan Kettering Cancer Center
Onsite source document verification (SDV) of site clinical trial data is resource intense and inefficient. Our primary objectives were to show return on investment (ROI) for: 1) implementing virtual monitoring and auditing (VMA) versus onsite SDV, 2) assessing monitor satisfaction with Memorial Sloan Kettering Cancer Center’s (MSK) VMA system performance, and 3) using a real time digital feedback Monitoring Visit Form (MVF) to improve clinical research (CR) protocol audit readiness.  Speakers will discuss how VMA decreased both data review latency and query resolution and allowed for more efficient use of staff time and effort. Establishing virtual monitoring in 2011 enabled rapid scaling to a completely virtual model during the COVID19 pandemic. Real time digital MVF feedback lets teams focus efforts on specific areas of protocol compliance, increase data quality, and ensure inspection readiness.

2:40 – 3:30                
Critical Communication in the Trenches – Skills Learned During a Pandemic, With a 
Team of 30, Across 3 Sites, While Enrolling 500 Subjects in a Pivotal Study, With the FDA on their way and the Whole World Watching!
Terrence Howell, MBA, Director of Quality Affairs and Michelle Klick, LPN, CCRP, Clinical Research Manager, Institute for Global Health and Translational Science, SUNY Upstate Medical University
Clinical research is by nature, made up of 1,000 tiny details that come together to answer a scientific question. What happens when you communicate 999 of those details? This presentation will be an interactive discussion on effective communication tools that are used to successfully manage a clinical trial. Come ready to laugh, and cry and say AMEN! as we discuss all the ways Research Professionals communicate.

3:30 – 3:35                
Final Comments

You can attend in person or via conference Zoom access.  This program will not be recorded.

In Person Attendance:  Please send completed On-site Registration Form 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: 

  • Attending in Person: 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 October 3 to:  durdonk@upstate.edu.
  • If you are attending virtually via Zoom, there is no charge to attend. Registration is required to receive Zoom access instructions.  Virtual registration:  https://upstate.zoom.us/meeting/register/tJAsc-2tqz0oE91ZS9HWZhJ5U1U5CXVJMOe5

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 hours of continuing education hours.