New York State SOCRA Chapter Clinical Research Program
Open to the Public (Registration Required/Catering Fee)
The Lodge Skaneateles, 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 – 9:20 Real World Evidence: Being Creative & Innovative in Submissions (FDA acceptance and uses for submissions)
Eric J. Fernandez, MD, Global Clinical Research Lead, Healthcare Systems & Technology (HST), Worldwide Medical, Baxter Healthcare Corporation
9:20 – 10:20 Developing a Training Program for Study Team Members
Erinn McDowell, MS, CCRP, Cancer Center Clinical Trials Manager Upstate Medical University
10:20 – 10:40 Quick Beverage Break
10:40 – 11:20 Biobanking Project
Andrew Brindle, Executive Vice President, Research and Development, Quadrant Biosciences
11:20 – 12:00 Research Registries and Repositories
Nikki Mason, MS, CIP, Chief Compliance Officer for Research, HRPP Director, Upstate Medical University
12:00 – 1:00 Lunch and Networking
1:00 – 1:45 Innovate Upstate: Re-Imagining an Academic Medical Center as a Regional Asset for Innovation and Entrepreneurship
David Amberg, Vice President for Research, Upstate Medical University
1:45 – 3:00 Networking Session
Session Moderators: Kylie Sands, Nikki Mason, Emily Spinner
1) In the next 15 minutes your task is to meet someone who has done the following:
• Pediatric Research that involves a Minor Increase Over Minimal Risk
• Exception from Informed Consent for Emergency Research
• Expanded Access and/or Compassionate Care Treatment Protocol
• Consenting process that involves a Legally Authorized Representative
2) Brief discussion about the above topics from a regulatory and operational perspective.
3) What is one thing your site/company/team does super well you are proud of?
4) What is one area you are interested in but don’t know who to seek out for Information?
5) Research Study Enrollment Demographics
• FDA Draft Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products
• Does your organization track demographic information as it relates to enrollment and if so, how is this accomplished?
• Do you have an internal or sponsor-driven application?
• Do you use any sources of truth to verify, such as an electronic health record?
3:00 – 3:15 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 5.7 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 March 5th to: kylie.sands@rochesterregional.org
As SOCRA Chapters are not allowed to accept any funds/payments, all catering fees must be paid directly to the catering vendor: