We are pleased to inform you that CVBF coordinated the preparation of the first edition of the Trial Start up and Monitoring online Training Courses in the conect4children (c4c) project. These two courses were launched on 25 May 2020 and were available for all clinical site staff and healthcare professionals involved in the c4c funded clinical trials.
The courses provided general knowledge on activities to start paediatric clinical trials, as well as good-quality monitoring of paediatric clinical trials in the experimental sites. In line with the international and European standards, such as ICH E6 Good Clinical Practice (R2) taking into account the guidelines specific for children (e.g., Ethical considerations for clinical trials on medicinal products conducted with minors and ICH E11 Harmonised tripartite guideline, and clinical investigation of medicinal products in the paediatric population (R1)).
The Trial Start up course provided information on how to plan trial start up, Trial Master File set up, study submission package and administrative procedures. In addition, qualifications and site initiation visits were addressed. In the Monitoring course, the role of the monitor was described, site staff responsibilities in clinical trial monitoring as well as monitoring procedures, monitoring plan and SOPs were outlined.