Electronic Informed Consent Frequently Asked Questions – Florence’s eConsent

In this post, we address common questions about Florence eConsent, a virtual informed consent platform for clinical research. Topics include platform capabilities, compliance, cost, customer support, implementation, and technical specifications. Read on to learn how Florence eConsent can streamline your informed consent process.

eConsent Platform Capabilities Questions

What is Florence eConsent and what problem does it solve?

Florence eConsent is a compliant and easy-to-use virtual informed consent solution. Participants can navigate and sign their informed consent forms from any device, anywhere and access any study they are participating in. Florence eConsent is designed to digitize and improve the flow of paper-based informed consent.

For more details on what eConsent can do for you, review the one-pager here.

What languages does eConsent support?

Florence eConsent currently supports English and Spanish. However, our platform is flexible and can be extended to other languages for customers.

How do I access Florence eConsent?

As a cloud-based web application, Florence eConsent can be accessed from anywhere in the world by both clinical users and participants, ensuring better document quality and inspection readiness. 

Access the clinical user online platform by logging in here.

Access the participant portal by logging in here.

Compliance and Regulatory Questions

Is Florence eConsent 21 CFR Part 11 compliant?

Yes, eConsent is fully 21 CFR Part 11 compliant and is in full compliance with all current rules and regulations. Additionally, Florence eConsent is EU Annex 11 compliant. 

Learn more about Part 11 compliance here and Annex 11 compliance here

To view the most exhaustive and recent compliance list, please reach out to your Florence contact for access to the Compliance Team.

Cost Questions

How much does Florence eConsent cost?
Taking into account your organization’s dynamics and study profiles, Florence eConsent is priced to reflect the ROI of your research platform. 

If you are interested in learning how much Florence may cost for your organization, please contact us here and our sales team will be happy to assist you.

Customer Support and Implementation Questions

How much staff effort is required to transition to an eConsent?

Clients typically identify an internal project owner to facilitate implementation and manage ongoing support, training, and validation tasks. In our experience, this person might be a Clinical Regulatory Manager, Nurse Educator, Clinical Research Nurse, Clinical Trial Associate/Manager, or Clinical Project Manager depending on the organization’s structure.

How long does implementation take for eConsent?

Depending on the number of studies you wish to transition to for your roll out phase Florence eConsent implementation for all new studies takes as little as 4 weeks to a few months. We typically see implementation completed between 6 and 8 weeks based on project team bandwidth and conflicting priorities such as other implementations.  Florence has a designated Implementation team that guides new clients every step of the way with personalized materials, best practice recommendations for use, certification training courses, and tested software processes for optimized final workflows

If you are interested in learning more about how our implementation process works, connect with us here.

How does Florence eConsent ensure adoption?

Having worked with over 12,000 active research teams across Florence products, our dedicated implementation team has developed a flexible process to encourage investigator and study staff adoption of Florence eConsent 

Our team works closely with your organization to drive software adoption and training through our best practice recommendations to encourage positive results. Learn more about technology adoption and implementation here.. 

What support is offered for eConsent after going live?
As a boutique service provider, Florence offers dedicated resources to facilitate clients’ understanding and efficient use of all products. These resources include a help desk, a FAQ page, a community forum, Q&A sessions, video resources and training courses based on user pathway needs.

Our support team is available around the clock to quickly help with software questions as needed. If you are interested in learning more about how our ongoing support process works, talk with a Florence team member here.

eConsent Tech Specs and Integration Questions

Who owns the data input to Florence eConsent?
If you purchase Florence eConsent, data ownership and responsibility stays with you, as well as related metadata. Florence customers have full control over which parties can see and access information and data at any given time. Audit history can be viewed.

How does eConsent connect to eBinders?
The eBinders and eConsent integration is seamless, you don’t even need help from Florence! 

Not only can you use the same account for eBinders and eConsent and easily move from system to system, you can also save all signed forms from eConsent to your eBinders folder in just a few clicks.

Does eConsent integrate with other software?
Yes, eConsent has an open API, which means it can integrate with all other software systems that are open to integrate. We work with all clients to verify that their software processes are seamless across systems and duplicate work is avoided at all costs.

In conclusion, Florence eConsent offers a comprehensive, compliant, and user-friendly solution to the complex world of virtual informed consent. By streamlining the process, integrating with existing software systems, and ensuring regulatory compliance, Florence eConsent empowers clinical research organizations to focus on their core mission of advancing medical knowledge and improving patient outcomes.

We invite you to learn more about how Florence’s eConsent can revolutionize your informed consent management and support your research endeavors. Reach out to our team today for a personalized consultation and discover the difference that a seamless, efficient, and fully compliant eConsent solution can make in your clinical trials.