Table 3 Criterion type CCE terms with further elaboration.
CCE Term | Rule | Scope |
|---|---|---|
Further parameters | ||
Commercial Entity | Permitted | Part of Resource |
Permitted only if it has been authorised in the informed consent. | ||
Clinical Care Use | Permitted | Part of Resource |
Use for diagnosis purpose, only if a specific authorisation in the informed consent is present. | ||
Clinical Research Use | Permitted | Part of Resource |
Use for research purposes, including research to improve diagnosis and treatment, in the field of the disease for which the biological materials have been biobanked. Specific authorisation in the informed consent is mandatory. | ||
Disease Specific Use | Obligated | Whole of Resource |
Participants can choose if samples may be used ONLY for research projects on the participant’s disease or for other research projects on other diseases, too. | ||
Geographical Area | Permitted | Whole of Resource |
The use, in countries not covered by GDPR, requires specific authorisation included in the informed consent. | ||
Profit Motivated Use | Permitted | Part of Resource |
Depending on consent of the participant. | ||
Regulatory Jurisdiction | Obligated | Whole of Resource |
Use of data is only allowed where the EU General Data Protection Regulation applies. | ||
Research Use | Obligated | Whole of Resource |
Use for research purposes in the field of the disease for which the biological materials have been stored in the biobank. Most represented diseases are rare metabolic disorders, chromosome disorders, neurological diseases and overgrowth disorders. | ||
Use As Control | Obligated | Whole of Resource |
Where the proposed use is relating to the field of the disease for which the biological materials have been biobanked. | ||
