Enrolment to the course will be open from 27th April – 18th May
Name of the course: Monitoring
Edition of the course: 1st Edition
Starting date: 25/05/2020
Closing date: 25/07/2020
Who is the course for?
Trial managers, study coordinators, monitors, data managers and hospital administrative personnel involved in clinical trials start up and management, invited and selected by NHs
**if you are part of a PoV Team and you are interested into taking part in the Course, please contact your Country’s National Hub. The person resonsible for Training and Education will be your point of contact as participant in a c4c Academy Course.
Max. number of persons that each national hub can enrol: 10
Bloom’s Taxonomy Level of the Course: Understanding and Applying
The course requires 3 study hours for a general knowledge for good quality monitoring of paediatric clinical trials in the experimental sites, in line with International and European 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 role of monitor will be described, site staff responsibilities in clinical trial monitoring, monitoring procedures, monitoring plan and SOPs will all be covered. Information on safety monitoring will also be provided.
- Teachers’ presentations and voice over will be provided to deliver the following modules:
- The role and responsibilities of the Monitor in a Clinical Trial.
- Monitor’s role during the study (routine and close out visits), monitor’s tasks in keeping contacts with sites and remote monitoring
- Site staff responsibilities in clinical trial monitoring
- Monitoring procedures and SOPs. Monitoring Plan complying with GCP
- Safety monitoring
- Loic Notelet
- Betty Polikar
- Lucie Spatenkova
- Silvia Pulici
- Cristina Manfredi