How Gustave Roussy Verifies Informed Consents Remotely with Agatha when including patients in a clinical study
Company Name: Gustave Roussy
Industry: Hospital & Healthcare
Gustave Roussy is a global expertise center fully focusing on the care of patients diagnosed with cancer. The institute treats all cancers at every stage of life and is internationally renowned for its expertise in treating rare and complex tumors.
The institute treats all cancers at every stage of life and is internationally renowned for its expertise in treating rare and complex tumors. With 3,200 professionals, Gustave Roussy focuses on cancer research and development and sponsors around 100 clinical studies, including 55 opened cohort studies. The institute collaborates with approximately 250 clinical sites across Europe.
The Need for electronic Informed Consent
Gustave Roussy promotes and manages an important domestic and international research program.
One of the activities that a study sponsor is responsible for is verifying the “Informed Consent” forms of the patients participating in a study. The informed consent form informs the patient of their participation in the study, and with their signature, the patient indicates their acceptance to participate. These forms are systematically verified during audits and inspections. The patient signature is mandatory for patient participation in a study.
In an effort to facilitate this verification and ensure the closest control from the inclusion of a patient to a clinical study, Gustave Roussy decided it needed an application that would enable the review of patient Informed Consent forms remotely, limiting the onsite travel of site monitors to the participating studies.
The Agatha eConsent application has been selected because it fulfilled all of the requirements outlined by Gustave Roussy.
“The Agatha application fulfills our expectations. The easy-to-use interface, and the ability to review and annotate Informed Consent forms directly in the application, will help our CRAs ensure that informed consents are confirmed with a very short delay, greatly limiting their onsite travel to clinical sites.”
“When we saw how Agatha’s eConsent application worked, we were impressed with how easy it was to use and how close Agatha’s standard processes to gather and review Informed Consent forms was to our expectations.”
There were a few reasons Gustave Roussy selected Agatha’s eConsent application. First and foremost is the simple ease of use of Agatha’s application which includes the ability to preview and annotate consent documents directly in the application. In addition, this application is compliant with European GDPR requirements.
The Agatha team was also able to demonstrate a partially configured informed consent process during the selection process that closely aligned with their expectations.
About the Project
The Agatha team worked closely with Gustave Roussy’s team, taking an iterative approach to adapting Agatha’s standard eConsent application to the institute’s exact requirements.
Busy with their daily jobs managing clinical trials and clinical sites, the institute’s team could focus on the setup of Agatha; however, it was key for Agatha to provide a flexible implementation schedule. The combined project team met for three sessions to outline the requirements and set up needed. Agatha’s team configured the application accordingly between sessions, spending roughly 5-10 days total to get the eConsent application ready, train Gustave Roussy’s team, and go live.
“Our team is very busy working on clinical trials, and the flexibility of Agatha allowed us to quickly ramp up on their application for the targeted studies.” – Thibaud MOTREFF, CRA Team Manager and Clinical promotion team coordinator, Gustave Roussy
Gustave Roussy’s primary users of the eConsent application have completed training, and the institute is rolling out the application to the targeted clinical sites.