Time: 12-1 pm
To Sign-up: Link to ACRP eConsent Webinar
Registration Deadline: February 27, 2017
In this webinar Sandra “SAM” Sather, VP, Clinical Pathways, Regulatory & Quality lead for eConsent, CRF Health Trial Consent and Michael Conde, is the Senior Director of Technical Solutions at CRF Health discuss how eConsent (eIC) improves investigator, sponsor and IRB oversight for informed consent and decreases risks. This session addresses how the newly released FDA and OHRP joint guidance “Use of Electronic Informed Consent – Questions and Answers” reflects the current regulatory thinking on eIC particularly since it is seen as either a partner to improve the paper process or replace paper completely. This session also addresses two of the most important updates in regards to research stakeholders interested in using eIC, and the IRB process and approach to electronic informed consent.
This session will focus on:
- 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.
- View examples of eConsent approaches.
- Discuss the importance of collaboration between the ethics committees, sponsors, and sites related to eConsent implementation and monitoring.
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- The Clinical Pathways Team