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Frequently Asked Questions

The ileak registry℠

FAQ for the ileak registry℠

Thank you for your interest in the ileak registry℠. Please see below some frequently asked questions. If you have additional questions that are not listed, please read the full FAQ document or contact us at registry@spinalcsfleak.org!

What is the purpose of the ileak registry℠?

The primary aim of the ileak registry℠ is to conduct a prospectively planned and efficient natural history study to improve understanding of spinal cerebrospinal fluid (CSF) leak and intracranial hypotension (also referred to as intracranial hypovolemia) and their progression overtime. While protecting participant privacy, the registry is designed to help researchers, clinicians, and industry partners learn more about spinal CSF leak and advance knowledge that can improve diagnosis, treatment, and outcomes.

Other registry objectives include the following:

  • To provide a convenient online platform for participants (or caregivers) to self-report cases of spinal CSF leak / intracranial hypotension.
  • To develop a contact registry within the ileak registry℠ (e.g., to notify participants of research studies and clinical trials).
  • To characterize and describe the population affected by spinal CSF leak / intracranial hypotension as a whole, enhancing the understanding of disease prevalence, phenotype, the progression of signs and symptoms over time, treatment responses, and prognosis.
  • To help the spinal CSF leak / intracranial hypotension community develop recommendations and clinicians understanding of best practice and standards of care.
  • To be a case-finding resource for researchers either retrospectively studying the pathophysiology of spinal CSF leak / intracranial hypotension or intervention outcomes or designing prospective studies, including trials of novel treatments.

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. 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 to advance understanding, improve clinical care, and support future research and treatment efforts.

What is a Natural History Study?

A natural history study is a study designed to track the course of a disease over time. It includes people who have a specific medical condition or disease. It may also include those who are at risk of developing the condition/disease. This type of research identifies demographic, genetic, environmental and other information that may be common within the disease and its outcomes. A natural history study can also show the differences in symptoms and changes over time that are seen in different people with the same disease. Natural history studies often aim to find unknown similarities within the disease population. They have many potential uses such as patient care best practice development and clinical trial recruitment. Data for natural history
studies are often collected via patient registries.

How is the data collected?

Data is collected through IAMRARE®, a secure web-based platform developed and maintained by the National Organization for Rare Disorders, Inc. (NORD®), and accessible by computer, tablet, mobile device, or NORD’s new mobile application. IAMRARE® currently supports more than 70 patient-powered natural history studies representing over 140 rare conditions. Please see the rest of our FAQs for more information about NORD®.

Participants contribute data by answering questions to a series of structured surveys developed according to registry standards and in collaboration with patients, clinicians, and other conditionspecific experts.

What types of data will be collected in the ileak registry℠?

The data collected includes but is not limited to:

  • Socio-demographics
  • Diagnosis
  • Medical history
  • Treatment and care
  • Disease progression and review of current symptoms
  • Quality of life

What is a CRID Number? And how does it help me as a registry participant?

A CRID (Clinical Research ID) is a unique, de-identified code used to securely link your information within and across studies without using personal identifiers. It helps ensure your data remains consistent over time, even if your name changes or if multiple participants have similar names.

The CRID also saves you time by allowing previously provided information to be reused in approved studies or surveys conducted through the registry platform. You won’t have to enter the same information twice.

Participation in the CRID system is optional but highly encouraged. You can learn more and create a CRID number at https://thecrid.org/

What is a Research Study Sponsor?

A Research Study Sponsor is an individual, company, institution, or organization. They are responsible for choosing appropriately trained and experienced researchers to conduct the study. They are also responsible for the initiation and management of a research study. Additionally, the sponsor is responsible for the costs associated with conducting a registry study. They ensure that the study is conducted in a reputable, ethical manner and upholds regulations as they apply to the study. The sponsor of this registry is the Spinal CSF Leak Foundation.