In December 2016, the US Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) finalized their guidance on electronic Informed Consent (eIC) in an effort to improve the patient experience and overall protections for human subjects. Since the paper process alone does not support the complexities of the concepts included in consents – from human rights to scientific procedures and study design – change was necessary. If followed correctly, the new final guidance will improve development and management of informed consents with effective presentation of information, compliance with informed consent regulations for multiple stakeholders, oversight by the investigator, plus many more areas.
Join us for this session which will outline how the new guidance and electronic systems can decrease – or even eliminate – the likelihood of quality gaps seen in the paper approach.
- Learn what’s most important about the new FDA/OHRP guidance
- Identify how the integration of electronic consent better supports subjects and sites during consenting and throughout the trial
- Recognize how eIC improves compliance with informed consent regulatory requirements; as well as allowing for timely remote oversight
- Discuss key activities to ensure the best approach to eIC integration (e.g., a hybrid model)
- Note how eIC fits into a risk-based monitoring approach for all stakeholders
- Formulate a plan for inspection readiness for investigators, ethics committees, and sponsor/CROs
- Receive a review of the new final guidance and how it shapes your future efforts: What affect it has on your current systems, paper and/or electronic
- Dispel misconceptions about eIC – sorting fact from fiction