The transition to EHR involves far more that medical records. Paper based documents and processes such as Informed Consent has also entered the digital age. Along with that change comes other regulatory requirement for Clinical Trials, IRBs. These include changes which include requirements for the FDA.
Course Description:
For those who manage clinical trials, collecting informed consent through traditional paper-based methods is quickly becoming outdated.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.
The next landscape change will occur to reduce duplications, errors and increase the uniformity of informed consent for routine medical procedures including electronic signature verification via secured certification keys. Much like 'Verisign,
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