Determine Patients’ Needs

Building a Registry

It is important that the information in your registry database will be helpful to the stakeholders in the therapy development process. You also want to collect the information using the correct methods so that it can be used by medical researchers, industry partners, and the FDA. Because this process is crucial to laying the foundation for the therapy development process, especially for rare and genetic diseases, the National Center for Advancing Translational Sciences (NCATS) established a website devoted to building your registry

NCATS Rare Diseases Registry Program (RaDaR) includes step by step guidance to help you develop your registry. It is not a registry platform, but rather a collection of best practices, templates, and resources to help you achieve your goal. So if you want to learn more about building a registry or you are ready to begin, we encourage you to explore RaDaR:

Resources

Natural History Study
FAQ Orphan Products Natural History Grants Program U. S. Food and Drug Administration (FDA) (link)
OOPD Grant Application Overview U. S. Food and Drug Administration (FDA) (link)
Building a Registry
Rare Diseases Registry Program (RaDaR) National Center for Advancing Translational Sciences (NCATS) (link)