NORD-FDA Natural History Study Frequently Asked Questions
- What is the NORD Registry Program?
- The NORD Registry Program is a compilation of services that assist member organizations through all the steps of developing, launching and running a Registry.
- What is the NORD Natural History Study Database Project?
- The NORD Natural History Study Database Project is one component of the greater NORD Registry Project. The natural history study database project seeks to enable the collection of disease-specific natural history information for rare diseases. A natural history study is a systematic collection and analysis of comprehensive information from people with a disease intended to advance the understanding of the disease and how it is expressed over time. NORD has developed a platform for designing, deploying, and maintaining natural history studies that is designed to provide a cost-effective and efficient way to conduct disease-specific longitudinal natural history studies. Through a cooperative agreement with the FDA, NORD will be expanding its natural history study database in 2015-2016 to develop and launch 20 new natural history studies on the NORD platform.
- What is a Registry?
- A Registry is an organized online program for collection, storage, retrieval, and dissemination of a clearly defined set of data collected on identifiable individuals for a specific and specified purpose.
- What types of data can be collected in a Registry?
- All types of data can be collected, including data related to the following:
- Natural history data that captures longitudinal information about the disease
- Diagnosis and treatment
- Management of care
- Quality of life
- Clinical testing samples
- Clinician reporting
- Healthcare providers
- What are the uses of having a Registry?
- Data from a patient registry can help to:
- Unite the patient and research community,
- Learn about a disease/condition,
- Improve quality of care,
- Develop treatments,
- Develop research hypotheses, and
- Improve the management of healthcare.
- How are the data collected?
- The data are collected online by users that register and grant consent to enter their own personal data or the data on behalf another participant if he or she is legally authorized to do so.
- Can data be collected worldwide?
- Yes, a registry can be accessed from anywhere in the world, and international participation by the patient community and research collaborations are supported.
- Where are the data stored?
- The data are stored on NORD’s secure Registry Platform that is hosted on an IIS server in concert with a Microsoft SQL Server database.
- Are the data safe?
- Yes, the registry follows strict government guidelines to assure patient information is protected. The Platform is also served over HTTPS, providing encryption of traffic to prevent eavesdropping and prevent man-in-the-middle attacks. Communication between the registry platform application server and the database are also encrypted.
- Who owns the data?
- The identifiable and de-identifiable data are owned by the specific patient organizations. Each organization decides how and with whom to share the data. A subset of the de-identified data collected from registry participants across the Platform is shared with NORD to support research on all rare diseases, including studies comparing diseases.
- How is the Registry maintained?
- Member organizations provide the day-to-day management of their registry, and NORD provides technical support and ongoing periodic releases of new features.
- What do you need to run a Registry?
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- The desire to have a registry
- Patient engagement
- Disease expertise to support the registry
- Resources to fund and manage the Registry