Glossary

For further reference, this page introduces and defines several concepts and terms that users of the OSSE registry software should be familiar with.

• Registry refers to an instance of the OSSE software. It will be configured with a selection of data entry forms for basic or longitudinal data.
• The central OSSE components (MDR, OSSE.FormEditor, ...) are shared between multiple registry instances and are hosted by the Institute of Medical Informatics, Johann Wolfgang Goethe-University Frankfurt.
• The Metadata Repository (MDR) allows the precise definition of the data elements which will be captured in a registry. Each registry receives its own namespace, containing the defined data elements.
• Data elements represent variables or parameters to be captured in a registry. They are identified by a unique URN (urn:<namespace>:dataelement:<ID>:<version>). With each revision (i.e. editing information of a data element) the version number increases by 1.
• Data elements can be arranged in records as major units to be used as clusters in forms, e.g. to create tables.
• The OSSE.FormEditor allows the creation of data entry forms from selected data elements defined in the MDR namespace linked to the registry.
• Data elements or records can be marked as Repeatable which will allow the corresponding item to be completed an unlimited number of times when entering data.
• The OSSE.EDC (Electronic Data Capture) is the central OSSE component for building, managing, and using a registry. It is the main component for data management, i.e., the recording and storage of medical data (MDAT).
• MDAT refers to the medical data recorded and stored in a registry in the OSSE.EDC.
• A registry administrator is a registry user assigned the role Global Admin who is responsible for configuring and managing a registry. This includes the registry's setup A registry administrator generally does not have access to the data stored in the registry.
• Locations are centres, hospitals, clinical departments, or medical practices, who share a registry. Each location may have a location administrator who is appointed by the registry administrator.
• Roles and permissions: Permissions are defined on data classes (e.g. forms or types of data), while roles are collections of permissions. Roles are required to assign the appropriate permissions to registry users according to their tasks, access rights, and location.
• A user can log on to a registry and has one or more roles that provide him with the required permissions to perform their tasks in a registry.
• To prevent the re-identification of patients, medical data is pseudonymized using the Mainzelliste pseudonymization software and _identity management**. Ideally, this should be operated by a trusted third party.
• IDAT refers to a patient's identifying (or personal) data such as first and last name, date of birth, place of birth, or address. In accordance with data protections recommendations and informational separation of powers, IDAT is stored separately from MDAT in the registry's identity management.
• In the OSSE.EDC, a patient is represented by a pseudonym generated by the Mainzelliste called PID. Depending on the Permissions, Users from other locations are able to see entered medical data without accessing the patient’s identifying data.