A registry is a systematic collection of standardized data about a group of individuals. Two primary types of registries are relevant to translational science and the mission of NCATS: patient registries and contact registries.
Patient registries contain clinical data about individuals who have a specific condition or type of disease as well as contact and demographic information, such as age and gender. Some registries are defined and led by patient advocacy groups for specific or similar disease diagnoses and to track the course of a condition over time both with and without treatment. Researchers use this information to evaluate specified patient outcomes for a particular disease or condition.
The Rare Diseases Registry (RaDaR) program, formerly known as the Global Rare Diseases Registry Data Repository (GRDR) program, aims to define best practices for patient registries. RaDaR also strives to identify and adopt standards to support high-quality registries for rare diseases therapeutics development. To achieve these aims, RaDaR staff will: identify, develop and validate data standards, data collections and data sharing practices that can be used across the rare disease registry community; develop best practices for building high-quality registries able to support therapeutics development; and make these best practices and standards broadly available and easily accessible to the rare disease community.
A contact registry is a collection of contact information for a group of people who share a common interest, such as a specific disease or health-related topic. As the name implies, this type of registry offers the registry owner or administrator the ability to contact individuals listed to inform them about information of potential interest. For example, NCATS’ Rare Diseases Clinical Research Network (RDCRN) supports a contact registry of patients with rare diseases. These individuals have agreed to be contacted for possible clinical research opportunities and for updates about the progress of research projects.
Setting up a patient registry is significantly more involved and costly than having a contact registry for multiple reasons. For example, the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule mandates the way in which protected health information is used or shared. To enable the flow of health information needed to provide and promote high-quality health care and research while remaining HIPAA compliant, each individual is assigned a unique reference code and all personally identifiable information is removed.