Why ClinOne’s eConsent is a Game-Changer for Clinical Trial Management
DENVER, June 27, 2018 /PRNewswire/ — Patient consent is a critical process that has historically been highly inefficient and prone to error. Consequences for failing to properly consent patients can be as severe as an FDA 483 issuance to clinical trial investigators. That’s why ClinOne, a mobile clinical trial management solution, created an additional level of security for study participants and clinical trial sites by adding electronic consent capabilities to its platform.
“We are pleased to announce a technology that is critical to clinical trial stakeholders which will eliminate any violations related to Information Assurance and Privacy (ICF) compliance,” said ClinOne CEO Rob Bohacs. “Our eConsent technology will eliminate hundreds of man-hours at research sites which can instead be used to devote to patient care and eliminate significant risk.”
Improved clinical trial workflow for patient consent
ClinOne has mastered the optimum workflow for the consenting process, where patient and coordinators complete an electronic signature on an iPad Pro. The technology utilizes DocuSign where the principal investigator (PI) can sign remotely from his or her mobile device. As soon as the research coordinator completes the ICF with the patient, ClinOne sends a text message to the PI to prompt them to complete the ICF. Once the ICF is complete, the coordinator is notified and the investigational procedures can begin. The workflow is reduced from hours and even days to minutes.
ClinOne also allows patients to remotely consent in non-critical studies or procedures. When consenting a patient, the technology can utilize DocuSign’s FDA compliant remote consenting feature, where a patient or caregiver or co-parent can complete an ICF remotely, or across multiple locations from a research institution.
Real-time compliance tracking for re-consents
The greatest value is the real-time tracking of patient ICF’s and required re-consents, which has historically caused 85 percent of the challenges around incomplete ICF’s. The technology tracks ICF versions and recognizes active patients that require re-consents, notifying the PI, coordinator and patients.
“Perhaps even more important than a workflow, is real-time vigilance and oversight for compliance,” Bohacs says. “Our eConsent system provides weekly automated reports of completed consents and flags issues immediately.”
Automated consent logs
The system automatically generates consent notes and logs, which is mandated by the FDA for certain studies. An automatic log is created for log for all activities around a patient consent, time each step takes, notes who was present and what questions the patient had on which section of the ICF. Then a PDF is created and attached to the completed ICF, ready for an inspection.
The ClinOne solution and its suite of products were created to improve access to mission-critical clinical trial details through the web and mobile devices. The company’s sole mission is to allow important trial details to be at the fingertips of participating researchers. Currently, more than 2,600 active clinical trials in 50 countries rely on ClinOne’s technology. Visit www.clinone.com for more information.
SOURCE ClinOne, Inc.