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 has established links with the competent authority and the national ethics committee. |
| Capacity to provide competent consultation to regulatory authorities | Yes | STAND4Kids has links 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 and the broader pediatric community on general aspects of pediatric clinical trials as well as specific trial-focused training (with F2F and online meetings for specific trials). These activities align with c4c training activities whenever applicable. Examples of meetings include sessions during annual STAND4Kids meetings, sessions during Get Together sessions with sites, and sessions with our Third Party Portuguese Society of Pediatrics (all showcased here:https://www.stand4kids.pt/news-events/) |
| 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 following educational offer: -part of the Scientific and Coordination Committees of the Masters in Clinical Research at the Faculdade de Medicina, Universidade de Lisboa (https://www.medicina.ulisboa.pt/en/clinical-research), and coodinators of content focused on pediatric clinical trials as well as other topics; STAND4Kids also hosts master students for internships and research projects (4 students since its inception); -Clinical Research courses (not pediatrics specific) led by its partner academic CRO CETERA 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 (https://aidfm-cetera.com/category/formacao/short-courses-de-investigacao-clinica/?lang=pt-pt) -contributor to postgraduate courses and other educational initiatives from other portuguese institutions (including Lisboa - Biomedical Engineering and Porto https://sigarra.up.pt/fmup/en/ucurr_geral.ficha_uc_view?pv_ocorrencia_id=550722) with topics on pediatric trials and clinical networks. -host for internships from Clinical Pharmacology residency, Biomedical Engineering course, Data Scientist course STAND4Kids is also formally linked with the academic unit Laboratory of Clinical Pharmacology at Faculdade de Medicina, Universidade de Lisboa (https://www.medicina.ulisboa.pt/en/laboratory-clinical-pharmacology-and-therapeutics). |
| Training courses received over the last 2 years | Yes | STAND4Kids team members undergo certified GCP training, and a core c4c training academy course offer. Staff members have been trained on GDPR and CTR/CTIS. |
| Promotion of participation in clinical trials in countries with limited resources | No | |
| List of Countries |