2 - Network organisation and process
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
STAND4Kids – Supporting Pediatrics Trials in Portugal |
|
| Existence of an identified contact person for external enquiries | Yes | The network has a dedicated e-mail stand4kids@medicina.ulisboa.pt with restrictive access that is checked every day by the Project manager, who answers queries from all stakeholders. In case of absence, the e-mail is managed by another member of the network from the operational team. |
| Existence of an internal steering committee | No | The governance structure is currently being operationalised; planned for the transition post-conect4children support. |
| Existence of an external advisory steering committee directing the reporting party | No | The governance structure is currently being operationalised; planned for the transition post-conect4children support. |
| Existence of a website | Yes | www.stand4kids.pt |
| Existence of newsletter | Yes | Electronic newsletter, publicly available through our website and distributed to a contact list including key stakeholders and participating sites (a membership option is planned shortly) . First Newsletter can be accessed here (local language only): http://stand4kids.pt/news-events/ |
| Existence of internal databases for disease, condition treatment and/or outcome | Yes | STAND4Kids contributes to the database structure and procedures established by c4c focused on site clinical and operational capacities. STAND4Kids also holds an internal database with restricted access, managed by STAND4Kids; it does not include individual patient or investigator data. |
| Provisions to ascertain data protection and data security | No | Currently the network does not hold any individual patient data. |
| Procedures to access the database by third parties | No | The database is currently not directly available to third parties. It is used by STAND4Kids in selecting preferential sites and supporting site feasibility assessments or Investigators aiming to develop their investigator-driven studies. |
| Access to external databases/registries | No | STAND4Kids is collaborating closely with the competent authority and the national ethics committee to monitor pediatric trial activity in Portugal. |
| Standardised process to access an external database | No |