ERN CRANIO registry

BACKGROUND INFORMATION

AIM OF THE REGISTRY

To understand the course of a disease and investigate diagnostic procedures and treatments, we need a database (also known as a registry) to store collected information for research. This registry will be used to compare (long-term) results from a large number of patients from different countries and different health care providers. Based on these results we aim to identify the best treatment and follow-up protocols to optimise and standardise healthcare for patients with rare craniofacial and ENT disorders across Europe.

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To support the goals of ERN CRANIO, to pool together disease-specific expertise, knowledge and resources from across Europe, a European-wide registry is being developed for patients with rare and complex craniofacial anomalies, and ENT disorders. This registry allows for secure collection of patient data from across Europe, which will improve the understanding and treatment of these conditions. It will also facilitate research and lead to better care for these patients. 

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WHAT DOES THE REGISTRY ENTAIL?

The registry covers a wide range of rare craniofacial anomalies and ENT disorders, including craniosynostosis, cleft lip and palate, rare genetic deafness, craniofacial microsomia, and orodental anomalies. For each diagnosis, a group of European specialists worked together to reach consensus on relevant outcome measures and treatment endpoints. This will allow for comparison of care on a level not previously seen, which will greatly increase opportunities for improvement. 

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HOW WAS IT DEVELOPED?

The registry was built and is hosted in collaboration with MOLGENIS, a company that specializes in registry development and support. The platform is user-friendly and provides the highest levels of patient data security. Additionally, it supports FAIR interfaces for data exchange. 

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HOW IS PATIENT DATA USED?

Only the data required for such research will be recorded and may be shared with users as outlined below. Such data may include age, sex, the signs and symptoms of the disease, results of diagnostic procedures (e.g., laboratory test results, genetic information, imaging studies), as well as therapeutic interventions (e.g. surgery) and their (long-term) outcomes. The patient’s data privacy will be secured as described below in this form. Only the healthcare providers of your child/the patient will be able to link your child/the patient to your child/the patient. Therefore, the risk of re-identification by unauthorized persons is minimal.

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The data collected in this registry is used to improve the delivery of healthcare, including the diagnosis, treatment and prognosis of patients with rare and/or complex craniofacial anomalies and ear, nose and throat (ENT) disorders. Only users authorised by the ERN CRANIO Scientific Committee can use the data. This Committee is composed of qualified health professionals and patients' representatives from the ERN CRANIO member hospitals. The Scientific Committee ensures requests to access the registry data are in line with the procedures described in the data access policies. The Scientific Committee may provide data access to clinical researchers from within ERN CRANIO, to develop projects, policies or studies aimed to improve the delivery of healthcare for rare diseases. Also, registry data will be made public via annual reports and may be shared with health authorities, policy makers and regulators to inform their decisions on rare disease health policy and approval of medicines. The data will not be used for commercial purposes.

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DATA TRANSFERS OUTSIDE THE EU

Data without any personally identifiable information may also be provided to researchers working in countries outside the EU, where the General Data Protection Regulation (GDPR) does not apply. In this case, a written agreement will be set up to ensure that the data is processed in compliance with the GDPR. You may choose if you want to allow the transfer of the data of your child/the patient to non-EU countries to contribute to projects directly aligned with the aims of this registry within a framework compliant with GDPR.

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WHAT ARE THE BENEFITS?

While there is no direct benefit from participating in this registry, the knowledge about the disease will be improved. This may benefit your child/the patient and other patients suffering from the same disease. The participants may benefit by facilitated access to clinical studies aimed to prevent and treat the disease.