JackAnswered on May 10, 2023 11:10 PM
Clinical studies is a great use case for Jotform as I can attest. We are currently using Jotform in a fully decentralized pilot study for a Class II medical device. We are using Jotform to pre-screen potential participants; we use it for a daily study diary that participants complete, we use it to build eCase Report Forms for all of the online meetings between study participants and the clinical coordinators and to document and evaluate adverse events using Jotform workflow.
Our next step will be to conduct a pivotal study that would be submitted to the FDA for approval. However, we are concerned about using Jotform in the pivotal study because we can't find any information on whether Jotform is 21 CFF Part 11 compliant.
Is there somebody at Jotform we could speak to about your plans to validate and verify your platform to ensure it aligns with FDA regulations?
Vanessa JotForm SupportAnswered on May 11, 2023 03:21 AM
Thanks for contacting Jotform Support. Regardless of which plan you have, all of your forms are served across a protected 256-bit Secure Socket Layer (SSL) connection that uses a SHA256 Certificate. It's industry-standard protection. For encrypted forms, submissions are encrypted with high-grade RSA 2048 on our user's computers and then transferred and stored securely on our servers.
Please note that Jotform is loaded with powerful features to help you collect and manage sensitive patient information. Please check the Jotform HIPAA compliance page and let us know if you have any questions.
For pricing page information, please visit this link and let us know if you have any questions.
Let us know if there’s anything else we can do for you.