MobileConsent System
Aptia Systems' software developers collaborated with
a large medical institution to develop MobileConsent Software System, a fully automated, mobile solution
for obtaining informed consent from patients scheduled for a medical procedure or
enrolling in a clinical trial. The software application and wireless mobile device
enhances education and documentation with photo and audio recording capability.
It also has barcode reading, fingerprint recognition and signature recording capabilities.
This mobile device is a fully functional interactive Tablet PC that is shatter resistant
and can be wiped with a disinfecting solution. Audio and video interfaces ensure
uniform and comprehensive information management and communication.
The use of the Tablet PC allows each patient to hear and see exactly the same information
and description of the proposed study. It also means that the patient responses
are recorded and encrypted on completion of the process.
Features and Benefits of the MobileConsent System
- Streamlines patient recruitment process
- Standardizes digital validation of the informed consent procedure via Bluetooth
- Increases patient comprehension and acceptance of risk factors
- Digitally records patient acceptance and consent
- Barcode capability facilitates management of patient-specific supplies and tracking
- Determined to save 7 to 15 hours of Clinical Investigation staff time each week
- Meets 21CFR, Part 11 technical requirements of a compliant system
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