2 - Network organisation and process
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
TEDDY - European Network of Excellence for Paediatric Research |
|
| Existence of an identified contact person for external enquiries | Yes | Enquiries are collected through a contact form published on the Network's website and forwarded to Partners according to the subject of the request. |
| Existence of an internal steering committee | Yes | TEDDY Scientific Coordinating Committee. |
| Existence of an external advisory steering committee directing the reporting party | Yes | TEDDY Strategic Planning Board. |
| Existence of a website | Yes | www.teddynetwork.net |
| Existence of newsletter | Yes | Electronic newsletter |
| Existence of internal databases for disease, condition treatment and/or outcome | Yes | For each study a disease database is created. The number and the disease type of each patient are collected and stored for guiding future trials. Individual patients data are not included. A survey is ongoing to collect more data from existing databases at each TEDDY participating center. Outcome database is also available for Thalassemia patients (Italian multiregional Thalassemia Patients Registry). |
| Provisions to ascertain data protection and data security | Yes | Databases are managed according to the current rules. SOPs are developed to guarantee data protection and data security. e-CRF (electronic Case Report Form), combining technology, simplicity, privacy and data security, in order to comply with the GCP (Good Clinical Practice) and regulations on the protection of people's safety and well-being are developed. |
| 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. For each project requiring data sharing for analysis and study conduct, TEDDY proposes a ‘Data Sharing Agreement’ (DSA) to be signed by all the participants. DSA should include at least details on: - Type of data to be transferred and future use - Data controller responsibilities (data protection and security) - Centre responsibilities (data integrity and anonymisation/no-reidentification allowed). |
| Access to external databases/registries | No | |
| Standardised process to access an external database | No |