Enrolment will be open from 10th May 2021 to 30th April 2024
Name of the course: Clinical 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
To enrol in this course, please contact your National Hub who will supply you with the course password.
Your National Hub’s Referent Person for Training and Education will verify your eligibility to enroll to the Course and provide you with the Course’s enrolment password.
Once you receive this Course’s Enrolment Password from your National Hub, please log in on c4c Academy Platform.
If you don’t have an account yet, click on Create new account and follow the instructions.
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 interested into taking part in this course, please contact your country’s National Hub.
Max. number of persons that each national hub can enrol: unrestricted
Bloom’s Taxonomy Level of the Course: 1,2
Paula Pokorna – paula email@example.com
Viviana Giannuzzi – firstname.lastname@example.org
Betty Polikar – email@example.com
Ana Dilo – firstname.lastname@example.org
Mariagrazia Felisi – email@example.com