c4c is excited to launch the first edition of two new online training courses – TRIAL START UP and MONITORING. This training is available to the c4c network’s clinical site staff and healthcare professionals involved in the c4c funded clinical trials.
If you are interested, please get in contact with your National Hub.
Both courses will require x 3 study hours for a general knowledge to start paediatric clinical trials and for good quality monitoring of paediatric clinical trials in the experimental sites, in line with European and International standards such as ICH E6 Good Clinical Practice (R2) taking into particular 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. Clinical investigation of medicinal products in the paediatric population (R1)).
The Trial Start-Up Course will provide information on the following: how to plan a trial start-up, trial master file set up, study submission package and administrative procedures. In addition, qualifications and site initiation visits will also be addressed.
The Monitoring Course will provide information on the following: the role of the monitor, site staff responsibilities in clinical trial monitoring, monitoring procedures, monitoring plan, and SOPs. In addition, details on safety monitoring will be provided.
More courses are to be developed in the future. Stay tuned!