The purpose of the Informed consent is to educate patients properly so that they can decide whether or not to take part in the research study. The problem is that when all organizational requirements are packed into the document, the language can become confusing and difficult for patients to understand. Eager to participate some patients may still sign the informed consent form, even if they don’t fully understand what their participation to the study really means. In order to improve both patient’s understanding and later engagement, the informed consent must became electronic.
Genius ENGAGE™ is a mobile App to support patients and investigators in the whole workflow from reviewing the content of the consent form, assessing the understanding through a questionnaire up to signing the ICF.
Genius ENGAGE™ is the industry’s first ever electronic Informed Consent solution whose digital workflow is fully combined with the eTMF, and integrated with the eCRF, admitting data entry only after the patient has digitally signed the consent form.
Genius ENGAGE™ automatically retrieves the latest approved version of any appropriate document or material, such as the Informed Consent Form, videos or other supportive material specific for each site, from the eTMF. This improves the consent process quality and dramatically reduces the risk of findings during inspections, attributed to an error in the consent process.
Genius ENGAGE™ allows for a multi-media and interactive Informed Consent process on a flexible computer tablet based platform, which is compliant with all legal and regulatory requirements. Ultimately Genius ENGAGE™ will enable remote study models, such as patient-centric or site-less clinical trials and potentially sets new quality standards.