Susan Brink
Instructor Susan Brink
Product Id 601103
Duration 60 Minutes  
Version Recorded
Original Price $300
Special Offer Price $15
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Electronic Informed Consent for Clinical Trials: Why, What and How

Overview:

This webinar will present an exploration of trends that are leading to adoption of e-consent; options are available for e-consent, what is involved in implementing e-consent. A live demonstration of an e-consent will set the stage for implementation questions.

Why Should You Attend : Why are you considering e-consent:

  • Lack of patient interest in trial participation
  • Need for greater patient involvement during trial
  • Need to explain complex terms and protocol
  • Need to implement remote monitoring
What concerns you the most:
  • Reaction of the IRB
  • FDA non-acceptance of the consents
  • Patient inability to use technology
  • Lack of acceptance by clinical staff
  • Cost
  • Timelines

Areas Covered in the Session
  • Using an e-consent to assist low literacy patient populations understand your trial
  • Using e-consent to assist patients in understanding their role in a complex clinical trial.
  • Working with an IRB in the review of a e-consent
  • Understanding the cost drivers of an e-consent process
  • Features of an e-consent. Deciding what is important to your trial.

Who Will Benefit:
  • Clinical trial Innovation teams
  • VP, Clinical trials
  • Clinical Operations (VP, Senior Managers, Trial Managers)
  • IT innovation leads
  • Managers, VPs Research Portfolios

Speaker Profile
Dr. Brink co-founded ConsentSolutions, Inc. in 2006 to further the development of media-based approaches to informed consent for clinical trials. She is the CEO and President. The company grew out of Phase II SBIR NCI funding for the development of an online informed consent process for clinical trials, on which she was the PI. Dr. Brink has authored articles in peer-reviewed publications discussing the effect of media on the patient experience, the need for e-consent, and the pathways to implementation of electronic informed consent in clinical trials. She has conducted research and reported on patient decision-making processes, and patient knowledge outcomes when using e-consent compared to a paper-based consent. Dr. Brink has presented on electronic informed consent at DIA, DIACanada, PRIMR, ACRP, NIH and SoCRA, focusing on the benefits for patients, clinical sites and sponsors.

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