New York State

New York State SOCRA Chapter Spring Program

Date: Friday, March 23, 2018 

 Program Time: 8:15 AM - 3:00 PM (8:00 - 8:15 AM: Sign-in) 

 Location: Welch Allyn Lodge, 4355 State Street Rd, Skaneateles Falls, NY

Speakers: 

Kathi Durdon, MA, CCRP, SOCRA NYS Chapter Chair, Director of Operations, CNY Biotech Accelerator at Upstate Medical University

Jessica Hurley, PharmD, RPh, Hematology Medical Science Liaison
Kelsey Frost, PharmD, RPh, Solid Tumor Medical Science Liaison, Janssen Scientific Affairs, LLC

Irfan A. Khan, MD, FACC, FHRS, Founder, Chief Strategy Officer, Circuit Clinical

Glenda Guest, CCRA, RQAP-GCP, Vice-President and Vice-Chair, Board of Directors, Director of Marketing, Norwich Clinical Research Associates

Liz Kuney, MS, CCRP, Senior Medical Writer, BioTelemetry Research (Cardiocore&VirtualScopics)

Shayla A. Graham, BA, Pediatric GI Research Coordinator, SUNY Upstate Medical University

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 8:00 - 8:25: Sign-In and Networking

8:25 - 8:30: Welcome and Introduction

Kathi Durdon, MA, CCRP, SOCRA NYS Chapter Chair, Director of Operations, CNY Biotech Accelerator at Upstate Medical University

8:30 - 9:30: Multiple Myeloma and Prostate Cancer - Disease State Awareness

Jessica Hurley, PharmD, RPh, Hematology Medical Science Liaison, and

Kelsey Frost, PharmD, RPh, Solid Tumor Medical Science Liaison, Janssen Scientific Affairs, LLC

Multiple myeloma and prostate cancer are both diseases with evolving treatment landscapes. A review of multiple myeloma will include diagnosis and staging, response criteria, and treatment selection considerations, followed by a review of prostate cancer screening, staging, and discussion of the treatment continuum from early stages of disease to metastatic, castration-resistant disease.

 9:30 - 9:50: Break

9:50 - 10:50: eConsent and eSource: the revolution is here, now what?

Irfan A. Khan, MD, FACC, FHRS, Founder, Chief Strategy Officer, Circuit Clinical

This talk will: 

* define eConsent and eSource and their variations

* review the history of the regulatory guidance on electronic consent and electronic source

* review adoption challenges over the past 15 years of attempts to bring eSource and eConsent into clinical research

* explore why we are seeing adoption escalate with both sponsors and sites

* discuss ways to optimize adoption of eConsent while maintaining a focus on compliance

10:50 - 11:50: Quality System Approaches: Case Report Form Mapping to Address

Limitations of Electronic Health Record Systems for Direct Source Document Verification

Glenda Guest, CCRA, RQAP-GCP, Vice-President and Vice-Chair, Board of Directors, Director of Marketing, Norwich Clinical Research Associates

The clinical research industry continues to struggle with verifying source data in electronic health record systems. Many monitors and auditors accept whatever research sites provide as evidence of 'source data' when direct access to the EHR is not appropriate. But how confident can we be that the alternative methods of providing access to source that is housed within an EHR are complete and accurate? CRF Mapping may be an interim solution as the move to direct data transfer from EHR to clinical study databases becomes the norm.

 

11:50 - 12:50: Lunch and Networking

12:50 - 1:50: Imaging Endpoints in Today's Oncology Trials

Liz Kuney, MS, CCRP, Senior Medical Writer, BioTelemetry Research (Cardiocore&VirtualScopics)

Liz Kuney, a seasoned medical writer and clinical research professional, has been involved in developing central review paradigms and writing imaging charters for 14 years, as well as other clinical, regulatory, and published materials for diverse disease indications and investigational therapies. Liz will discuss the influence of medical imaging in designing and conducting oncology trials, an overview of immunomodulatory therapies as they related to imaging, and current response criteria (eg, iRECIST, iRANO) that address the hallmarks of immuno-oncology.

 1:50 - 2:50: How to Turn Conflict into Collaboration

Shayla A. Graham, BA, Pediatric GI Research Coordinator, SUNY Upstate Medical University

We all face varying levels of conflict on a daily basis. When you hear the word conflict what comes to mind for you? Quite often conflict is associated with negative connotation and poor self-control.Within my presentation, I plan to outline the myths and realities of conflict to strengthen partnerships, build shared accountability, and foster collaboration.

 2:50 - 3:00: Program Wrap-Up

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 There is no registration fee for this program. There is a $43.00 fee made directly to the catering vendor to cover continental breakfast, (1) break beverage and lunch. There is no cost for parking.

 Catering Fee: $43.00 Payable to "Eurest Dining Services"*

Send RSVP/Catering Payment to "Eurest Dining Services" by March 17 to:
          The Lodge at Welch Allyn
          4355 State Street Rd., Skaneateles Falls, NY 13153

OR - you can pay by credit card, please call 315-291-3700, thelodge@welchallyn.com

OR - if you are a Welch Allyn employee, provide your department Cost Center Account #

 Program Contact: Kathi Durdon durdonk@upstate.edu

*Please note - the Lodge will not be able to provide reimbursement of catering fee's after March 17 as the food count will go in at that time.      

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SOCRA continuing education approval pending; expected 5.25 hours SOCRA accepts documentation of candidate participation in continuing education programs forre-certification for programs applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.

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