The FPIES Global Patient Registry: An Introduction and Overview

The FPIES Global Patient Registry An Introduction and Overview

Part 1 of 3 in a Registry Series

In November 2013, we at The FPIES Foundation presented the first-of-its-kind FPIES Global Patient Registry, via the Patient Crossroads CONNECT program.

Some Key Terms:

·         Patient Registry: Also referred to as a “disease registry” or “clinical registry,” a Patient Registry is a program that collects and stores data related to health information for a specific purpose and in an organized and uniform manner.

·         De-identified Data: Information that is stripped of any and all identifying characteristics (name, email, etc) so that those viewing the data cannot see any connection to the participant from whom it came

·         Institutional Review Board (IRB): this may also be referred to as an ethics review board. It is put into place in order to approve, monitor and review research that involves people-- it exists in order to protect research participants (http://www.medterms.com/script/main/art.asp?articlekey=22413)

There are two essential parts to the registry:

·         The patient registry, which houses surveys (general questions and FPIES-specific questions) for registered participants to complete.

◦General Surveys will mainly utilize questions from the Patient Crossroads question library, a library of previously IRB-approved questions for use by any of the participating registry programs utilizing the CONNECT platform

◦     FPIES-Specific Surveys will utilize questions engineered by The FPIES Foundation's medical advisory board, with support from the Executive Board. Those questions, once internally approved, will then be sent for approval by an IRB (Institutional Review Board) before being submitted to the Patient Crossroads CONNECT program for final approval and  survey publication on the FPIES Global Patient Registry.

·         The data portal, a newly released component of the CONNECT program, is for use by medical professionals, researchers, and other industry professionals (such as pharmaceutical companies). The portal is free for these professionals to register and allows them to view the de-identified, anonymous information entered into the patient registry by registry participants

How does the FPIES Global Patient Registry work?

The FPIES Global Patient Registry is set up through Patient Crossroads' Connect program-- a program offering platforms for rare disease organizations to create registries for their individual patient populations and data portals to display de-identified information from these registries. Registered participants, as well as registered medical, research and pharmaceutical professionals, can then view the information in a secured location. The registry is intended to present a “big picture” of FPIES and all of the issues that may or may not affect each individual patient. It aims to further research endeavors, examine improved treatments and achieve a better understanding of this diagnosis.

An important privacy feature of a research registry is the collection of data with de-identified information

De-identified information means that when you submit information into any of the surveys or the registration process of the Connect database, the information will not be able to be attached to you or your child's identifying characteristics. The information will be stored by means of a code, accessible only to Patient Crossroads staff. Even if you select the option to allow researchers to contact you, the contacting is done through Patient Crossroads. The researcher contacting you still does not have any identifying information about you, your child or even your contact information. All of those are protected, making this database secure and confidential. In fact, its privacy standards are so high, the Patient Crossroads registry system is utilized by NIH (the National Institute of  Health) to power its Global Rare Diseases Patient Registry and Data Repository (GRDR)!

How can I register today?

1.      Go to the FPIES Foundation's home page (www.fpiesfoundation.org) and click on the blue “Connect” logo on the left side of the page

2.      You will arrive at the home page for The FPIES Foundation Global Registry. Click the blue box that says “Click to Register Now!”

3.      Complete the “Consent and Registration” section. Click “Register” and you are ready to go!

4.      On your dashboard page, you will be able to select surveys to complete at your convenience. View the results as you complete each one and learn more about the FPIES community as you CONNECT!! Be sure to register each member of your family diagnosed with FPIES

5.      For PORTAL Registration, simply go to the patient crossroads homepage at www.patientcrossroads.com and click on the button that says “log in/sign up” and follow the prompts!

6.      For additional support, contact us at contact@thefpiesfoundation.org

	Patient Registry	Data Portal
What information can be viewed?	De-identified data from the FPIES Global Patient Registry	De-identified data from the FPIES Global Patient Registry
Who can register?	Individuals diagnosed with FPIES can be registered by their guardians to be survey participants	Medical professionals, researchers, industry professionals
How is my information protected?	All information submitted by participants is de-identified-- this means that all identifying characteristics (name, contact info, etc) are removed from the information in the registry. In fact, the privacy standards are so high, the Patient Crossroads registry system is utilized by NIH (the National Institute of  Health) to power its Global Rare Diseases Patient Registry and Data Repository (GRDR)!	·         All information submitted by participants is de-identified ·         If data portal participants wish to contact registry participants, Patient Crossroads does not disclose any information to these portal participants, but directs the communication to the registry participant without revealing any identifying info in the process. ·         Once contacted, it is the choice of the participant whether or not to reveal any information to the individual contacting them.
Why would someone contact me?	If you select the option to be contacted (this is part of the registration page-- you may opt in or opt out without your decision impacting your ability to participate in the registry)you may be contacted in regards to participation in clinical trials

For more information and FAQ about the Patient Crossroads CONNECT program, go to: https://connect.patientcrossroads.org/en/home/frequently-asked-questions.html

The FPIES Global Patient Registry

• This registry is operated on the Patient Crossroads CONNECT platform and adheres to the Patient Crossroads privacy policy and terms of use.
• For questions regarding the registry’s privacy policy, terms of use, and/or any other questions regarding the FPIES Global Patient Registry, please email us: contact@thefpiesfoundation.org.

This post was written by the Executive Board of The FPIES Foundation