ENS@T: European network of researchers, which provides clinical annotations together with biomaterial from patients with adrenal tumors as a service to the scientific community conducting research on adrenal diseases.
ENS@T full members: An individual who has been accepted by the ENS@T steering committee upon application and who is in good standing. An ENS@T full member can have dual roles as “provider” and “requester”
ENS@T registry: Clinical registry, which provides a means of connecting the data from the specialist centres across Europe within a single Virtual Research Environment (www.ensat.org/registries.htm).
ENS@T working group: Group of full ENS@T members dedicated to specific aspects of adrenal tumor research.
ENS@T working group scientific board: Group of members of an ENS@T working group which have been elected by the members of the working group. Reflecting the size of the respective working group the number of the scientific board members should range between 3 and 8 persons. Members of the scientific board should preferably be “providers”. Members of an ENS@T working group scientific board are appointed for the duration of 3 years, which may be extended for one further term.
“Provider”: Clinician who cares for patients and has access to original clinical annotations and biomaterial or researcher who has access to biomaterial. The “provider” has to be full ENS@T member.
“Requester”: Researcher who aims at performing investigations on clinical annotations and/or biomaterial from patients with adrenal tumors. The “requester” has to be full ENS@T member.
2. Acquisition of clinical annotations and biomaterial:
Clinical centers that have applied and have been approved by their local ethical committee to participate in the “Registry and Biobank of the European Network for the Study of Adrenal Tumours (ENS@T)” can enrol eligible patients.
Patients who have given written informed consent to participate in the study may provide clinical annotations and biomaterial as appropriate. Biomaterial may be stored in the local clinical centre.
Clinicians (“provider”) can enter the patient’s clinical annotations in a pseudonymised fashion into the ENS@T registry (www.ensat.org/registries.htm).
3. Access and usage of clinical annotations and biomaterial:
Upon request, clinical annotations may be accessed by full ENS@T members (“requester”) under the terms and conditions of this Agreement. Adherence to the Regulations of intellectual properties and material transfer agreement is mandatory.
An investigator (“requester”) may present the outline of a specific study (according to Appendix B) via the head of the appropriate ENS@T working group to the working group’s scientific board.
If required, the requesting investigator secures funding and ethical approval for a specific study (if not covered by the “Registry and Biobank of the European Network for the Study of Adrenal Tumours (ENS@T)”)
The scientific board reviews and prioritizes presented study outlines and informs the ENS@T steering committee and the members of the appropriate working group.
The ENS@T steering committee ensure compatibility of the study outline with other working groups and can veto studies which affect other working groups.
Individual working group members (“providers”) may disallow usage of clinical annotations of their patient cohort for the presented study within 14 days of information (“opting out”).
Upon acceptance of the study outline the requesting investigator may search the ENS@T registry for information on patients (according to the appropriate level of written informed consent). The ENS@T registry verifies level of consent and provides appropriate level of access to non-identifiable data.
The Requester may contact providing clinician/researcher with eligible cases and initiate exchange of biomaterial in accordance with individual Material Exchange Forms (Appendix C).