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Orphanet Standard Operating Procedures
Inclusion of diseases
The list of diseases which are included in Orphanet is defined as any condition, no matter its origin, which has a prevalence lower than 1 in 2,000 in the European population. Each disease is described by a name, synonyms and key-words using the MESH terminology. Each disease is classified by medical specialty and placed under the responsibility of a scientific editor who is a recognised expert at the international level. There is at least one editor per medical speciality at the European level. The European experts form the European editorial board which is in charge of the Encyclopaedia. There is also one expert per speciality at the country level. These experts form the National scientific advisory board which validates the data on services.
Textual information on each disease
Each disease is associated with a text summarising the main characteristics of the disease, its prevalence, cause, prognosis and treatment. Every text is signed and dated. The texts are updated every two year, and more often if new relevant scientific facts are published. The texts are written in an English which is understandable by any non-specialist healthcare professional. All the texts are written in English. The summaries are systematically translated into French. Translation of the summaries in other languages is done, depending on available funding in corresponding countries.
Research projects
The research projects are identified using all the sources of information on research projects financed after a competitive process and a scientific evaluation. At the European level, the projects are those financed by the European Commission.
The researchers are then approached to give their consent to be listed in the database and to specify the list of diseases which applies to their programme. The list of research projects is updated once a year.Clinical laboratories
Clinical laboratories performing tests to diagnose rare diseases (by whatever methods) are identified using all sources of information such as lists of the Ministry of Health, national centres of expertise, lists of professional organisations, lists established by patient support groups, lists suggested by the scientific editors. A questionnaire is sent to these laboratories to specify the type of activity, the methods used, the list of diseases which are diagnosed and obtain the formal consent of the responsible person. All the data are validated by the national scientific expert of the relevant speciality before being released. The data are updated once a year.
Centres of expertise
Types of centres of expertise which are relevant for each disease are defined by the experts. Lists of centres of expertise of each type are established using all possible sources. A questionnaire is sent to potential clinicians to specify the type of their activity, and obtain their formal consent. For highly specialised centres of expertise, the clinicians responsible have to provide evidence of their expertise (list of publications, total number of patients, number of new patients per year). All lists are submitted to a national expert. These lists are updated once a year. Only comprehensive lists of centres of expertise can be released (as a matter of fairness).
Clinical trials
The on-going clinical trials for rare diseases are identified using all possible sources of information. Both the sponsors and the principal investigators have to be approached to give their consent to be listed in the database and to specify the disease which applies to their trial.
The list of clinical trials is updated at least once a year and automatically with the closing date.Registries/ databases of patients
Registries/ databases of patients are identified using all the sources of information. At the European level, the projects are those financed by the European Commission. Those in charge are then approached to give their consent to be listed in the database and to specify the diseases which apply to their registry. The list of registries is updated once a year.
Networks
Networks of professionals organised around a rare disease or a group of diseases are identified using the sources of information. Only networks which are funded or administratively identifiable are put in the database. At the European level, the projects are those financed by the European Commission. The persons in charge are then approached to give their consent to be listed in the database and to specify the diseases which apply to their network. The list of networks is updated once a year.
Support groups
Support groups are identified using all relevant ways including a web search and a partnership with Eurordis. The presidents are contacted to get their permission and establish the scope of diseases attached to their activity.
Orphan drugs
All orphan approved (in the US, Japan, Europe) drugs or non-orphan approved drugs with a specific indication for a rare disease are put in the database. The lists are established using the information available at the relevant governmental agencies.
Web sites
Each disease is linked to other relevant web sites. Each web site is evaluated for its relevance, consistency and credibility. The URL addresses are re-checked once a month. The web sites are listed with a comment on the language used and a description of the type of information which may be expected. Only sites run under the responsibility of a public agency or a non-profit organisation are listed.
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