5 -Training and educational capacity to build competencies
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
STAND4Kids – Supporting Pediatrics Trials in Portugal |
|
| Evidence of collaboration with regulatory authorities | No | All studies adopted by STAND4Kids comply with current national and international regulatory requirements and legislation. STAND4Kids is in the process of linking with the competent authority and the national ethics committee on several areas. |
| Capacity to provide competent consultation to regulatory authorities | Yes | STAND4Kids is linking with the competent authority and the national ethics committee on several areas, but for now no formal consultations have been established or requested. |
| Formal meetings for clinical trials | Yes | STAND4Kids provides regular tutorial hands-on training, support and coaching to sites on general aspects of pediatric clinical trials as well as specific trial-focused training (with F2F and online meetings for planned trials). These activities align with c4c training activities whenever applicable. |
| Training courses given over the last 2 years | Yes | Support to training in best practices regarding design, conduct and reporting of pediatric studies are key principles in STAND4Kids mission and values. STAND4KIDS participates in the organization and delivery of Clinical Research courses (not pediatrics specific) with the aim to provide to investigators of all clinical specialties the tools and knowledge needed to successfully achieve quality and high performance in all steps of clinical research, according to ICH 6 Good Clinical Practice Guideline; as well as a Masters in Clinical Research at the Faculty of Medicine University of Lisbon. STAND4Kids is also linked with an academic unit at this university. |
| Training courses received over the last 2 years | Yes | STAND4Kids team members have been trained on GDPR and CTR/CTIS. Other selected trainings include pediatric drug development and consent/assent in pediatrics. |
| Promotion of participation in clinical trials in countries with limited resources | No | |
| List of Countries |