Event Calendar

Closing Plenary Session

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2018 Agenda

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Sunday, September 30, 8:40 to 9:25

Lessons Learned: A Review of Common GCP Deficiencies and Examination of Warning Letters Issued to Clinical Investigator Sites 

Ms. Wright will review commonly cited deficiencies in clinical investigator inspections, using examples drawn from recent Warning Letters issued to clinical investigators.  The session will focus on lessons learn and allow attendees to learn from others' mistakes. 901

Presenter: Barbara Wright, BGS, Investigator, Food and Drug Administration 


Sunday, September 30, 9:25 to 10:10 

Implementing the Changes to the Common Rule 

Significant revisions to the Common Rule took effect January, 2017. The target audience for this presentation is individuals who are at research sites that conduct federally funded research. There have been several presentations discussing the changes to the Common Rule. This discussion will differ in that Ms. Gates will present actions needed to implement the changes at a research site and institutional review board. 903

Presenter: Cynthia Gates, JD, ADN, Director, IRB Administration, University of California, Davis 


Sunday, September 30, 10:30 to 11:00

Learning Compliance From Living It - What I Discovered When My Husband Died 

This session will cover what I learned from my husband dying in 2017. I learned a great deal from organ donation, donating tissue for research, and being on the receiving end of healthcare. After 30 years in research, I learned what you need to be aware of on the front line, taking into account privacy, HIPAA, and compliance needs when people die during your care. 904

Presenter: Kelly M. Willenberg, DBA, RN, CHRC, CHC, CCRP, CEO, Kelly Willenberg LLC 


Sunday, September 30, 11:00 to 11:30

Clinical Trial Recruiting- A Partnership  

Clinical trials are daunting no matter the age of the subject, but they are critical to advance treatments. How do you communicate that importance? How do you connect with patients that may not see the traditional advertisements? How do you overcome the fear factor? Ms. Lalani will cover these topics and discuss how sponsors can partner with sites, IRBs, advocacy groups and other stakeholders to positively drive patient recruitment. 905

Presenter: Jzaneen Lalani, JD, Chief Operating Officer, Curemark, LLC 


Sunday, September 30, 11:30 to 12:00

eConsent and eSource- The Revolution is Here: Now What? 

Dr. Khan will define eConsent and eSource and review their variations as well as the history of regulatory guidance and adoption challenges over the past 15 years.  Why we are seeing adoption improve with both sponsors and sites will be explored.  The talk will discuss ways to optimize adoption of eConsent while maintaining a focus on compliance. 906 

Presenter: Irfan Khan, MD, FACC, FHRS, Founder, Chief Strategy Officer, Circuit Clinical