06/24/2015
Date: August 10, 2015
Time: 1pm - 2:30pm EDT
Duration: 90 Minutes - Online
To sign-up follow this link: http://www.lifesciencetraininginstitute.com/doc/electronic-informed-consent-new-guidance-0001 to Life Science Training Institute (LSTI)
Course Description:
- For those that manage clinical trials, collecting informed consent through traditional paper-based methods is quickly becoming outdated. Electronic media offers many advantages for both patients and the advancement of scientific research.
- FDA recently released a draft information sheet on electronic informed consent (eICFs) that has significant implications for industry. Following this, the Office for Human Research Protections (OHRP) has released a request for comment which asks researchers whether the guidance should be applicable to both FDA and OHRP regulated trials. Understanding what these updates mean for your current procedures will allow your team to adjust operations according to the changing landscape.
- This course will address the implementation logistics of the questions answered by the FDA in the guidance, to allow you to develop an implementation plan for the short and long term. Come to this session to learn how to take the FDA recommendations into specific industry settings including sites, sponsors and IRBs.
- Questions to be addressed include:
- Who pays for the eICF services?
- Who initiates the use of an eICF for a trial?
- How to prepare for an audit
- How does this change source documentation and monitoring?
- Will the site now be audited for 21 CFR Part 11?
- What are the risks and mitigation strategy?