Starting a registry can seem like a huge undertaking, but you don’t have to tackle all the steps at once. This page provides an overview about registries and the major milestones that you help you build a successful registry.
Registries Come in a Variety of Shapes and Sizes
Registries can be classified based on the type of data collected, who is providing the data, and its goals. For example, contact registries collect only participant contact information, whereas research and natural history registries collect more detailed health and medical information.
Participant Provided Contact Information
- Data provided by participants.
- Collects only contact information.
- Often created and operated by one or more patients/parents.
- No approvals needed to collect data (e.g., may only require a simple disclaimer).
- Used to organize and grow the participant community.
- Helps participants learn about research studies.
Participant Provided Background History
- Data provided by participants.
- Collects patient-reported health and medical information.
- Often created and operated by patient advocacy groups (PAGs) or researchers.
- Has stricter data collection requirements for research use and publication (e.g., likely requires institutional review board (IRB) approval and compliance with the Federal Information Security Management Act (FISMA)).
- May have multiple objectives (e.g., to develop treatment or research hypotheses).
Clinician Provided Medical Data
Natural History Registry
- Data provided by clinician.
- Collects measurable clinical information and outcomes.
- Often created and operated by PAGs or researchers.
- Has stricter data collection requirements for research use and publication (e.g., Health Insurance Portability and Accountability Act of 1996 (HIPAA), IRB, FISMA).
- Observes clinical practice and patient experience but does not introduce any intervention.
Roadmap for Building a Successful Registry
The roadmap below includes the major milestones that can help guide you to develop and manage a successful registry.
Organize Your Community with a Contact Registry
Learn about your disease, find patients and caregivers willing to participant in your registry, build their trust, and grow and organize your participant community to support research. Collect participant contact information to start a registry for your rare disease.
Build Your Research Registry
Connect with researchers to understand the data they need to support their study goals. By using data standards and best practices, following the rules and regulations established, and obtaining the required approvals to collect participant information in an organized, systematic, and comprehensive way, you will be able to expand your registry to collect more detailed participant medical information to share with researchers.
Create Partnerships to Develop a Natural History Registry
Develop partnerships with clinicians, researchers, and industry to facilitate and encourage natural history studies to track the course of the disease over time.
Does a registry already exist for your rare disease?
The first step is to find out whether your rare disease already has a registry by searching the internet, reaching out to existing patient advocacy groups, and contacting rare diseases “umbrella” organizations. Umbrella organizations refer to nonprofit patient advocacy groups that cover the entire rare diseases community. Having one registry for a rare disease allows for the pooling of resources, reduces duplication of efforts, and avoids sources of competition. When you are certain that a registry for your rare disease doesn’t exist, you can use the information, tools, and resources provides on this website to create one.
Create your registry!
RaDaR gives you step-by-step guidance and tools to create a registry for your rare disease. It is important to use registry standards so that the information you collect can be used by the medical and research communities to find treatments and cures for your rare disease.
Already have a registry?
RaDaR offers ideas on how to engage with your participants and find researchers to use your data. Our Manage Your Registry steps provide information, resources, and tools to continuously update, assess, and improve your registry using best practices.