AIMED ENROLL©
GenAI-Driven Remote Verbal Consent
The GenAI component allow real-time answers to any questions related to the study procedures, possible risks and benefits.
The Investigator informs the patient about the possibility of a new trial participation for which the consent could be given via a remote verbal procedure avoiding his/her physical presence at site.
Patient receives via SMS a link to download the complete informed consent form for a preliminary reading. He/She will also receive the ID code to enter during the phone call and a link to start the phone call and the remote verbal consent procedure whenever possible or preferred.
After the patient verbally consents to participate in the study, a PDF document is generated that includes a transcript of the conversation, along with the exact date and time. This document is then sent to the research doctor for an electronic signature and subsequently provided to the patient as a record of their consent.
The remote verbal consent is particularly recommended in studies where a physical or electronic signature cannot be feasibly obtained such as:
- Retrospective and prospective non-interventional studies.
- Pre-study screening through analyses of biospecimens taken previously and stored at sites.
- The study that could not practicably be carried out without such approach.
- Low intervention and minimal risk studies enrolling subjects who for many reasons (age, culture standards, education….) are not familiar with the electronic or digital signature
- Emergency medicine studies where the voice interaction and verbal approval allows for a faster consent procedure.
- Reconsenting in case of minimal risk protocol amendment.
Here below the summary Features AI-MED ENROLL©
Flexible, fast and easy to use by users of any age, cultural standards and education.
Customized verbal communication and workflows.
Independent investigator and patient consent procedure but with the possibility of direct verbal interaction between parties.
Any language supported.
Very fast implementation.
GenAI-Driven Chatbot that answers in real-time any patient questions related to the study’s procedures and objectives.
Entire remote audio consent procedure recorded and after electronic signature by investigator transcribed on a final PDF document, PW protected and delivered to both patient and investigator.
Encryption and Audit trail of all audio interactions and transactions.
GCPs & GDPR Compliant and 21 CFR part 11 validated.
All Our Services
GenAI-Driven Synthetic Control Arm
GenAI-Driven RWD Acquisition & Analysis
Target Trial Emulation for Drug Repurposing
Realistic and Privacy-guarantees Synthetic Patient Data
Clinical Trial Simulation in Silico
Patient’s Data De-Identifier
GenAI-Driven Remote Verbal Consent
CONTACT DETAILS
info@aimedtrial.com
+39 3482630229