Learn About Registries

Know What Information to Collect

The type of information you’ll want to collect for your registry depends on the registry’s goal(s), the resources available to the registry’s owner(s), and other factors.

Contact and Demographic Information
What is it?
Contact information includes the name, phone number, and email address of the registry participant (usually either the patient or the patient’s parents/guardians). Demographic information usually collected includes the patient’s age, sex, and ethnicity. A registry is usually not required to obtain approval to collect this information, although many registries provide a simple disclaimer.

Why collect it?
Collecting contact and demographic information allows you to find participants living with the rare disease, discover how many people have the disease, build trust, and organize and grow your participant community to support research.

Patient Experience
What is it?
This type of information includes the experiences, perspectives, needs, and priorities of patients. A registry may need to obtain institutional review board (IRB) approval before collected patient experience information can be used for research or publication.

Why collect it?
Collecting this information directly from patients and/or their caregivers allows you to learn more about what it’s like for people living with the rare disease. This information can be shared with researchers to help them understand the direct experiences of people living with the disease.

Clinical Data
What is it?
Clinical data includes information about the patient’s health and their health care. Clinical data may come from electronic health records, administrative records, health insurance claims, health surveys, or clinical trials. This information tends to have stricter data collection requirements for research use and publication; the Health Insurance Portability and Accountability Act of 1996 (HIPAA), IRB, and Federal Information Security Management Act (FISMA) requirements will affect clinical data collection.

Why collect it?
By collecting clinical data, your registry will develop partnerships with clinicians, researchers, and industry to facilitate and encourage natural history studies to track the course of the disease over time. Natural history studies provide a greater understanding of disease development, current management guidelines, and disease treatments.