For Patients
The ileak registry℠
Welcome!
The ileak registry℠ is an online international patient registry designed to collect and analyze data from individuals affected by spinal cerebrospinal fluid (CSF) leak or intracranial hypotension. Sponsored by the Spinal CSF Leak Foundation and hosted by the National Organization for Rare Disorders (NORD®) through their IAMRARE® platform, the ileak registry℠ provides a secure and standardized framework for longitudinal data collection.
Participants (or their authorized representatives) can contribute information related to diagnosis, symptoms, treatment, quality of life, and disease outcomes. As a patient-centered research initiative, the ileak registry℠ enables real-world data generation driven by the spinal CSF leak community, for the spinal CSF leak community. We hope that the ileak registry℠ leads to advances in understanding, improvements in clinical care, and additional collaboration in the field.
What is a Patient Registry?
A patient registry is a collection of standardized information about a group of patients who share a condition. The information may be used for a variety of purposes such as conducting natural history studies and supporting disease-specific clinical trial recruitment.
The ileak registry℠ serves to:
- Support the design of clinical trials that explore new rare disease treatments;
- Describe the people who have spinal CSF leak / intracranial hypotension and better understand the variability and stages of spinal CSF leak / intracranial hypotension;
- Understand how spinal CSF leak / intracranial hypotension changes over a person’s lifetime;
- Learn about clinical practice patterns and variations over the course of treatment;
- Help develop best practices, management guidelines, and treatment recommendations so clinicians can provide the best standard of care and improve quality of life and outcomes for people with spinal CSF leak / intracranial hypotension;
- Identify people with spinal CSF leak / intracranial hypotension who might be willing to take part in other research studies or clinical trials. You will be able to choose whether you want to hear about these other studies.
What types of data will be collected in the ileak registry℠?
The ileak registry℠ collects data on the following topics:
- Socio-demographics
- Diagnosis
- Medical history
- Treatment and care
- Disease progression and review of current symptoms
- Quality of life
Is the data secure?
The ileak registry℠ follows strict government guidelines to assure patient information is protected. The platform is served over HTTPS, which means that the data is encrypted when being sent from the user’s browser to the NORD servers. The data is also kept encrypted in the NORD database. Communications between the registry platform application server and the database are also encrypted. As with any information one provides electronically, there is a very rare chance that privacy could be compromised. However, the registry and the security measures minimize the chance of this occurring.
As with any information provided electronically, there is a very rare chance that privacy could be compromised. However, the registry and its security measures are designed to minimize this risk.
Video links:
Janet Woodcock, Former Director CDER FDA on NORD Registry Program