Date: February 22, 2017
Time: 1pm - 2:30pm EST
Duration: 90 Minutes - Online
Sponsored by Life Science Training Institute
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 firstname.lastname@example.org.
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-The Clinical pathways team