FAQ

Medical registries are systematic, anonymized or pseudonymized collections of data on specific diseases. 

Alongside clinical trials, registries are among the most important tools to research new therapies as well as to improve and evaluate established treatment methods. Patient registries and the knowledge they provide are particularly significant for rare diseases, where there are often only very few patients in Germany. 

The National Registry for Rare Diseases (NARSE) aims to increase the knowledge about the prevalence and distribution of rare diseases in Germany. In addition, it aims to improve networking, knowledge exchange, and access to care, including new therapies. NARSE thus provides an important foundation for research efforts and the development of new treatment methods.

NARSE is operated b Berlin Institute of Health

Berlin Institute of Health at Charité (BIH)
Charité – Universitätsmedizin Berlin
Anna‐Louisa‐Karsch‐Str. 2
10178 Berlin 

In collaboration with university hospitals and Centers for Rare Diseases (ZSE) in Germany, NARSE is to be further developed so that, in the future, all rare diseases will be included. From the outset, registration has been possible for all rare diseases (prevalence less than 1 in 2,000).

The few registries currently existing in Germany vary considerably in terms of their quality, the organizations responsible for them, and the data they collect. Only very few registries, such as the Cystic Fibrosis Registry (Mukoviszidose-Register), are continuously maintained through significant civil society engagement in a way that ensures the majority of these patients in Germany are actually recorded and that the registry data constitutes a usable resource for research. Numerous other registries, however, could not be continued due to a lack of financing after the initial funding phase with public funds had ended. Cross-border European registries face similar challenges and therefore cannot replace national efforts. In the future, NARSE will also be able to incorporate data from other registries with the consent of the patients.

By participating in the registry, physicians gain an epidemiological overview of rare diseases. This enables them to expand their knowledge of these diseases, make evidence-based decisions, stay up to date on current developments, and exchange ideas with other specialists.

By participating in the registry, patients can benefit from improved medical care through evidence-based treatment plans. 

Information on research projects and clinical trials can provide access to innovative therapies, treatments, and medications that may improve quality of life. Additionally, there is the potential for networking and exchanging experiences with other patients. To this end, patients can register their interest in networking with the registry operator. 

In a process overseen by the NARSE Data Access Committee, people with similar symptoms are informed of this interest in networking, allowing contact groups to be formed. Further information can be found in the consent documents.  

Please contact your treating physician, who can complete the registration along with you. At a later date, patients will also be able to register on their own.

Under the “Register access” menu item, you will find information about the registration process. Once your access has been confirmed by the registry operator, you can log in directly to the NARSE login page using your personal username and password. You will receive the necessary information via email as part of the registration process.

Yes. The legal basis for the collection and use of data in NARSE is the informed consent provided by the patients themselves or their legal representatives. For more information, please refer to the privacy policy, which you can download here.

Consent to participate in NARSE is voluntary and may be withdrawn by patients at any time, even without providing a reason and without any direct disadvantage to you. The withdrawal must be submitted as a clear statement of intent directly to the Independent Trust Agency (Unabhängige Treuhandstelle, UTHS) or to the treating physician, who will forward it to the UTHS. Further information on withdrawing consent can be found in the consent documents, which you can download here. The contact information for the Trust Agency can be found under the menu item Contact.

If you agree to “further contact (erneute Kotaktaufnahme)” in the consent form, your physician may contact you again, for example with information about new research projects, new treatment options, or if other patients with the same condition have been found who wish to be in contact with others affected by the same condition. You can decide for yourself whether you would like to make contact. This will take place without further involvement from NARSE.

Broad consent (e.g., as used by the Medical Informatics Initiative (Medizininformatik-Initiative)) is a general authorization to use treatment data for various research purposes within a hospital network or research infrastructure. It is typically site-specific and allows for the secondary use of routine clinical data. 

NARSE, on the other hand, pursues a different goal and uses its own registry-specific data, which is specifically collected for the epidemiological recording of rare diseases. 

Therefore, a separate, specific consent is required that precisely describes: 

• what data is collected,
• for what purpose (establishment of a national, cross-disease registry),
• and how this data may be processed and shared in compliance with data protection regulations. 

NARSE collects a minimum data set on rare diseases based on the “Set of Common Data Elements” from the EU-RD Platform (European Platform for the Registration of Rare Diseases). 

Three entry forms are used to collect the following information: formal criteria, personal and family background, medical history and diagnosis. Various catalogs (terminologies, ontologies) are provided in NARSE to facilitate and standardize data entry. The entry process should generally take no more than 15 minutes. Further information on data entry can be found in the User Guide and the consent documents, which you can download here. 

To access NARSE, you need a PC or tablet with an active internet connection. Access to NARSE can be gained via a web browser that is as up-to-date as possible (we recommend using Mozilla Firefox, Google Chrome, Microsoft Edge, or Safari). No version of Microsoft Internet Explorer is supported.

Data is entered using forms, and data entry can be paused between individual forms. Within a single form, we recommend that you do not pause data entry for an extended period, as the forms currently cannot be saved temporarily if required fields are missing. If there is no activity for more than 60 minutes, a timeout occurs, during which users are automatically logged out and any changes made up to that point are lost.

If there are changes regarding formal criteria, personal and family history, medical history or diagnosis, the entry should be updated accordingly by the physician who made the entry. However, no longitudinal data is collected that would require regular entries or updates. 

Patients registered in NARSE have the right to be informed about whether and what data about them is stored in the registry, and to view or have this data corrected (data subject rights under the GDPR). Upon written request for information or modification submitted to the NARSE Trust Office, a human-readable printout of the data will be generated and provided to the registered individual. Further information on this can be found in the data protection policy and in the patient information, which you can download here. Changes will then be made by the registering physician after consultation.

Please contact the registry operator's technical support via email: support@narse.de

As long as a form has the status “Open,” the medical data entered can be updated or corrected at any time in the same way as during the initial data entry. Using the icons in the “functions (Funktionen)” column of the patient list, the personal data of the individuals concerned can be viewed, corrected, and deleted, provided the appropriate permissions are in place. Certain details (e.g., a patient’s location) can only be corrected directly in the database; for this, you must contact the technical support at support@narse.de. 

Yes, the data protection policy is available here.

Access permissions are assigned on a role-based basis so that each person can view only the data assigned and relevant to them. Each user has one or more roles corresponding to their function, which are used for login. To define access rights, data is classified according to its assignment to the data-collecting location and to the professional groups or functions involved. A detailed list of roles in NARSE, their descriptions, and the associated permissions can be found in the data protection policy, which you can download here. The attending physician and other authorized staff at the respective site have access to medical data for their own patients and, depending on their role, may also have access to identifying data.   

All data collected in the central components of NARSE is stored locally in databases on virtual servers. Only the administrators of the respective server have access to the data. All servers are located in data centers in Germany that use access control via smart cards or similarly secure tokens for authorized personnel. In addition, the medical data on the server is stored in a state-of-the-art encrypted container. The decryption password is known only to the administrators. 

Identifying data is not stored in the registry itself, but on a separate server operated by the trustee in a certified data center with data storage in Germany (Center for Information Services and High-Performance Computing (Zentrum für Informationsdienste und Hochleistungsrechnen - ZIH) at TU Dresden)). Information on data storage and security measures can be found in the data protection policy. You can find it here. 

The NARSE is intended to operate long-term, with no set end date. An internal process regularly reviews whether the registry should continue to operate or whether registry activities should be discontinued. All data will be stored until further notice: 

• until consent is withdrawn
• up to 10 years after all registry activities have been discontinued (Good Scientific Practice). 

Communication between components, as well as communication between a user’s browser and the OSSE EDC (Open-Source Registry System for Rare Diseases) or the Mainzelliste pseudonymization service at UTHS Dresden, always takes place via encrypted connections (HTTPS). The keys and certificates used for this purpose comply with currently recognized requirements. These can be found in the IT- Grundschutz catalogs of the Bundesamtes für Sicherheit in der Informationstechnik. Firewalls ensure that the servers on which the central components run are accessible only via those protocols and ports that are necessary for communication with users or other components. Administrative access is restricted to the operator’s intranet.

No, unfortunately, compensation is not available.

You can find the appropriate contact persons for technical and content-related questions under the menu item Contact.