Enrolment will be open from 10th May 2021 to 30th April 2024
Name of the course: Trial Start Up
Edition of the course: 3rd Edition
Starting date: 10 May 2021
Closing date: 30th Apr 2024
Starting Date Of The Enrolment: 31 December 2021
Ending Date of the Enrolment: until the closing date of the course
Course Duration: 3 hours
The Trial Start Up course provides a general overview on activities to start 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 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. Information on how to plan trial start up, Trial Master File set up, study submission package and administrative procedures will be provided. Moreover, notions on site qualification and site initiation visits will be addressed.
Module 1: Protocol implementation and comprehension of study design.
Module 2: Study Submission package (including CA/EC submission).
Module 3: Site contract from the legal backgrounds to the practical applications.
Module 4: Site qualification and site initiation visits.
Module 5: The Set Up of Trial Master File.
Who is the course for?
Trial managers, study coordinators, monitors, data managers and hospital administrative personnel involved in clinical trials start up and management
**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: unrestricted
Bloom’s Taxonomy Level of the Course: 1,2
- Paula Pokorna – paula firstname.lastname@example.org
- Viviana Giannuzzi – email@example.com
- Betty Polikar – firstname.lastname@example.org
- Ana Dilo – email@example.com
- Mariagrazia Felisi – firstname.lastname@example.org