2 - Network organisation and process
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
EPTRI (AISBL) - European Paediatric Translational Research Infrastructure (Association Internationale Sans But Lucrative) |
|
| Existence of an identified contact person for external enquiries | Yes | Enquiries can be made through the EPTRI website via the "Contact us" section. Here, there is the option to reach out by emailing info@eptri.eu or by completing and submitting the form. |
| Existence of an internal steering committee | Yes | The executive level of EPTRI is represented by the Board of Directors (BoD), which provides strategic leadership and direct activities. It is responsible for building the EPTRI community and for directing and coordinating operational bodies and activities. |
| Existence of an external advisory steering committee directing the reporting party | Yes | The Clinical Experts Committee (CEC) provides advice through ad hoc focus groups on clinical matters (related to the relevance and the conceptualization of the starting idea and/or the development of the clinical evaluation plan). The Patient Experts Committee (PEC) composed by representatives of the Young Persons Advisory Group (YPAG) provides advice on the identification of overall unmet needs and ethical, social and regulatory advice and finally age-tailored material co-developed with the support of national and international young advisory groups (YPAGs). |
| Existence of a website | Yes | https://eptri.eu/ |
| Existence of newsletter | Yes | Electronic newsletter is sent to EPTRI members, partners, patients' organisations, and other relevant Stakeholders every two months. Subscription form is available at https://eptri.eu/media/newsletter/ |
| Existence of internal databases for disease, condition treatment and/or outcome | Yes | -Regulatory database of relevant regulatory documents released by the competent authorities at national, European, and international level, periodically updated. -Central repository of projects and needs submitted by researchers for matching activities with potential manufacturers (SMEs and companies). - Electronic Research Services Database: a catalogue of the services and facilities provided by the more than 200 Research Units composing EPTRI organised at Platform level. It includes also contact details of related reference persons, main publications. - Internal Experts database, identified by disease area. Managed by EPTRI's Central Management Office. |
| Provisions to ascertain data protection and data security | Yes | The EPTRI Data Management Plan (DMP) is developed according to the European Commission proposed template and in compliance with the obligations deriving from the European General Data Protection Regulation Reg. (EU) 2016/679. It describes the data management life cycle for all data handled by EPTRI detailing what data will be collected, processed or generated and following what methodology and standards, whether and how data will be shared and/or made open, and how data will be curated and preserved. EPTRI has documented information security policies in place to ensure the confidentiality, integrity, and availability of information. Furthermore, EPTRI has a formal policy and supporting practices for classifying information within its organisation. The DMP is regularly updated including suggestions coming from the stakeholders on the adopted Data Access Policy. |
| Procedures to access the database by third parties | Yes | Databases are not accessible by third parties outside the Data Controller disposition. Access to personal data is not allowed. If a request of services is considered feasible the Service Manager acknowledges the taking in charge to the user’s request and asks the user to sign a Confidential Disclosure Agreement (CDA) and Framework Agreement. |
| Access to external databases/registries | Yes | Access to external databases is ensured through collaboration with networks and infrastructures like EOSC and Elixir. |
| Standardised process to access an external database | Yes | The EPTRI DMP includes, for each collected/generated data, the following information: - Data summary - Purpose of the data collection/generation - Types and formats of data and related origin - Specify if existing data is being re-used (if any) - Expected size of the data (if known) - Findable [FAIR] - Metadata provided (specifying standards adopted for creation) - Identifiability of data and use of persistent / unique identifiers (e.g. Digital Object Identifiers) - Naming conventions used - Versioning - Openly accessible [FAIR] - Indication of which data are openly available and how, including methods or software tools needed to access the data - Where the data (and associated metadata, documentation and code) are deposited - How access is provided in case there are any restrictions - Interoperable [FAIR] - Indication of what data and metadata vocabularies, standards or methodologies have been adopted to facilitate interoperability - Re-use [FAIR] - How the data will be licenced to permit the widest reuse possible - When the data will be made available for re-use specifying, where applicable, why and for what period a data embargo is needed - Data quality assurance - Length of time for which the data will remain re-usable - Data security - Ethical aspects |