Electronic Informed Consent (eIC): "How The New FDA/OHRP Final Guidance Affects You" - Attend the Feb 22nd WEB Session


Date: February 22, 2017

Time: 1pm - 2:30pm EST

Duration: 90 Minutes - Online

Sponsored by Life Science Training Institute

To Sign-up: https://www.lifesciencetraininginstitute.com/doc/electronic-informed-consent-eic-fda-ohrp-final-guidance-training-0001


An Electronic Informed Consent (eIC) solution needs to be flexible to support very simple to complex projects, as well as from high-risk treatment to non-interventional studies. The newly FDA and OHRP guidance “Use of Electronic Informed Consent – Questions and Answers” reflects the current regulatory thinking on eIC particularly since it is seen as a partner to the paper process instead having to be an either or proposition. This session also addresses 2 of the most important updates in regards to research stakeholders interested in using eIC and the IRB process and approach to eIC.

This session will focus on guidance highlights including:

  • Discuss key activities to ensure the best approach to eIC integration (e.g., a hybrid model)
  • Understanding continuous consent where a subject can get information sent to them between visits to better support being informed throughout the trial
  • Identifying how eIC should support interactivity and facilitate the subject’s comprehension of the information presented during the eIC process
  • Clarifying methods for eIC supporting rapid information communication between stakeholders (investigator and subjects, investigator and sponsor, etc.).
  • Formulating a plan for when FDA / OHRP audit the records and reports for eICs.

For more information, contact SAM at samsather@clinicalpathwaysresearch.com.

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Thank you

-The Clinical pathways team