By Raymond Nomizu, JD, CEO & Co-founder at CRIO
There is a common problem with most eConsent solutions: they don’t solve the “Re-consent Problem." In the majority of clinical trials, sponsors make mid-study amendments to the protocol, which necessitate a new version of the Informed Consent Form (ICF). ICH-GCP principles require that the investigator execute the new version of the ICF with an enrolled patient prior to performing any procedures under the new amendment – this re-consent is usually done at the outset of the patient’s next visit.
While a stand-alone eConsent solution can track versioning across subjects, it does not “know” when a patient is performing their next visit. Therefore, it's easy for site staff to forget to perform the re-consent - especially given that most sites are quite busy, and the fact that coordinators are often juggling multiple studies at a time.