Definition of Datatype
| Data Level | Definition |
|---|---|
| DATASET | This relates to the direct measurements collected from an experiment or other such observations. |
| Patient Registry | Patient registries are organised systems that use observational methods to collect uniform data on a population defined by a particular disease, condition, or exposure, and that is followed over time. (EMA - Patient registries | European Medicines Agency (europa.eu)) |
| Biobank | A collect and store biological materials that are annotated not only with medical, but often also epidemiological data (e.g., environmental exposures, lifestyle/occupational information). (Biobanks for Europe: A challenge for governance, section 3.1) |
| Guideline | A document providing guidance on the scientific or regulatory aspects of the development of medicines and applications for marketing authorisation. Although guidelines are not legally binding, applicants need to provide justification for any deviations. (Guideline | European Medicines Agency (europa.eu) |
Use Condition Terms Information
| Use Condition Term | Definition | Guidance for Term Parameter |
|---|
Rule Information
| Rule | Definition |
|---|---|
| Forbidden | This strictly prohibits the stated use. |
| Permitted | Indicates that the permission is absolute and universal. |
| Obligated | Indicates that not only is a use permitted but that it MUST be performed in practice. |
| No Stated Rule | No rule specified for this term. |
Term Parameter Information
The term parameter is used to provide specific details about a given Term, for example a country or region for the Geographical area. More general details about the statement as a whole should be entered into the condition parameter.