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 | Yes | Given the nature, size and context of our organization, as well as its emergence from a large publicly funded project, our governance structure currently consists of an internal Execute Leadership Team that combines combines strategic oversight with executive decision-making, acting as an internal steering committee. |
| Existence of an external advisory steering committee directing the reporting party | No | Currently external advisory input is sought from our partners (including the Portuguese Society of Pediatrics). The governance structure will transition after the conect4children project and an external advisory is planned. |
| Existence of a website | Yes | www.stand4kids.pt |
| Existence of newsletter | Yes | STAND4Kids has a newsletter entitled “Highlights”, sent out and published quarterly. It is publicly available through our website and our social media (Linkedin and Twitter), and distributed to a contact list including key stakeholders and participating sites. All "Highlights" are available here: https://www.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 (currently the c4c Site Profile). 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 | Yes | S4K does not hold any individual patient data and does not deliver GxP activities. Its partner academic CRO, CETERA, (https://aidfm-cetera.com/at-a-glance/) has all the provisions in place to ensure data protection and safety, through internal SOPs. |
| 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 | |
| Standardised process to access an external database | No |