Enrolment to the course will be open from 27th April – 18th May
Name of the course: Trial Start Up
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 on activities to start 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)). Information on how to plan a trial start up, trial master file set up, study submission package and administrative procedures will be provided. In addition, qualifications and site initiation visits will be addressed.
- Teachers’ presentations and voice over will be provided to deliver the following modules:
- Trial start-up and protocol implementation
- Study Submission package (including CA/EC submission)
- Site contract and administrative authorisation
- Site qualification and site initiation visits
- The Set Up of a Trial Master File
- Paula Pokorna
- Viviana Giannuzzi
- Betty Polikar
- Ana Dilo
- Mariagrazia Felisi