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 NIH/NCATS Global Rare Diseases Patient Registry Data Repository/GRDR® program supports a resource that maps and integrates coded data from numerous national and international patient registries for rare diseases. Eventually, data will be available for query by investigators to conduct various types of biomedical studies, including clinical trials. Through this program, NCATS also provides tools and information — such as common data elements, a template patient consent form (Word - 40KB), and access to institutional review boards — for organizations that want to establish patient registries in a standardized manner and to facilitate data sharing and interoperability between and among patient registries.
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.