4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
STAND4Kids – Supporting Pediatrics Trials in Portugal |
|
| Documented adherence to GCP guideline | Yes | All studies adopted by STAND4Kids comply with current GCP regulations and European CT guidance, as well as national legislation. Adherence to GCP and best practices in the design, conduct and reporting of studies are key principles in STAND4Kids mission and values. STAND4Kids’ staff is regularly trained in GCP requirements, provides GCP training at least twice yearly in GCP courses, and focuses on pediatric specific aspects of GCP. These principles align with c4c processes whenever applicable. |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | All studies adopted by STAND4Kids comply with national legislation and guidance on ethics requirements for clinical trials in children (from the National Ethics Committee for Clinical Research). Furthermore, adherence to pediatric-relevant ethical considerations in the design, conduct and reporting of studies are key principles in STAND4Kids mission and values. These principles align with c4c processes whenever applicable. |
| Documented adherence to ethical considerations | Yes | The National Ethics Committee for Clinical Research includes pediatric experts in its Executive Committee responsible for evaluating and approving intervention studies. |
| Availability of Standard Operating Procedures (SOP) | Yes | STAND4Kids has already implemented the following SOPs or related documents: communication internal and external, clinical trials agreements negotiation, feasibility assement, investigator site file management, site initiation, site monitoring, trial master file safety reporting, site closure. |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | STAND4Kids can provide monitoring activities for both academic and industry sponsored trials according to ICH 6 through an academic CRO (CETERA) under the umbrella hosting organization (AIDFM). |
| Capacity to monitor performance of collaborating centres | Yes | STAND4Kids approach aligns with the metric and performance management processes of c4c. SOPs are not publicly available. |
| Quality control and quality assurance, raceability and data safety | No | STAND4Kids is establishing a quality framework with metric aligned with c4c processes. SOPs are not currently accessible. |