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Digital Technology in Clinical Trials

This event is now offered in a new entirely virtual format.


Session 3 Track 1: Consenting in a Digital World: Opportunities and Challenges

Session Chair(s)

Jules T Mitchel

Jules T Mitchel

  • CEO
  • Target Health LLC, United States
As one of many steps for participation in a clinical trial, the informed consent process is based on a solemn and trusted interaction between a study subject and the clinical research site. Traditionally, the process involves a study subject being invited to participate in a clinical trial based on the study inclusion and exclusion criteria, reading the informed consent document (ICD) at the clinical trial site, and then having a dialogue to clarify matters. Finally, the ICD is signed manually by the study subject and the clinical investigator, and the paper copy is then given to the study subject and a hard copy stored in the subject’s study folder. With the advent of paperless, virtual and remote trials, the paper process as we know it today is a deterrent. Yet, we must be ever diligent not to lose the key purpose of the informed consent process and assure full transparency to clinical trial subjects. The current session will present the challenges and opportunities of using the eICD for domestic and global trials.
Learning Objective :

At the conclusion of this session, participants should be able to:

  • Appreciate the opportunities and challenges when transitioning from paper-based ICD’s to eICD’s
  • Know how to educate the study sites when transitioning from paper-based ICD’s to eICD’s
  • Manage a study where both paper-based and electronic ICD’s are used
  • Manage a study with disparate global regulatory and cultural differences
  • Involve regulators and IRBs/EC’s when using ICD’s

Speaker(s)

Jonathan Solomon Helfgott, MS

Speaker

Jonathan Solomon Helfgott, MS

  • Executive Director, Global Regulatory/Clinical Affairs
  • Stage 2 Innovations, United States
Michelle  Eli

Speaker

Michelle Eli

  • Clinical Project Management Advisor, Chorus
  • Eli Lilly and Company, United States
Susie  Song

Speaker

Susie Song

  • Senior Manager, Informed Consent Management Global Clinical Operations
  • Biogen, United States