2 - Network organisation and process
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
EPLTN - European Paediatric Liver Transplantation Network |
|
| Existence of an identified contact person for external enquiries | Yes | Prof. Ulrich Baumann, baumann.u@mh-hannover.de |
| Existence of an internal steering committee | Yes | The internal steering committee consists of five members. It is elected every two years on the occasion of an investigator meeting. |
| Existence of an external advisory steering committee directing the reporting party | No | |
| Existence of a website | No | A common website is under construction. |
| Existence of newsletter | No | A newsletter is not yet envisaged as such. Regularly updated Information on network activities will be made available to a wider interested public via the ESPGHAN homepage. |
| Existence of internal databases for disease, condition treatment and/or outcome | Yes | A common web-based data-base eCRF using MARVIN has been created for the currently ongoing first study of the research network. (https://hctc-chilsfree-demo.xclinical.net/marvin/admin/home.do?op=home) This eCRF will be linked to the biobank data base (MySamples) to facilitate the planning of future network-based studies. The MARVIN based eCRF and the biobank database (MySamples) are designed to allow future expansion of the network |
| Provisions to ascertain data protection and data security | Yes | Patient data are entered into the common study data base in an anonymised fashion only. Access to the data base is password protected and possible only for members of the research network actively involved in the currend study. Records for patient identification are kept at the respective research sites. Details on data entry and data anonymisation are clarified in the corresponding SOP. The web-based network is protected against unauthorised access in compliance with national and international standards for data protection. |
| Procedures to access the database by third parties | Yes | Data can be shared with third parties following discussion and unanimous consent among network members. Details are clarified in the corresponding SOP |
| Access to external databases/registries | Yes | Links to ELTR/ Eurotransplant databases would be highly appreciated and discussions are currently under way. |
| Standardised process to access an external database | No |