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.


General Description:  

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.


Programme:

  • 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

BLOOM’S TAXONOMY LEVEL OF THE COURSE: 1, 2

Faculty:

  • Paula Pokorna – paula pokornakarlov@seznam.cz

  • Viviana Giannuzzi – vg@benzifoundation.org

  • Betty Polikar – betty.polikar@opbg.net

  • Ana Dilo – adilo@cvbf.net

  • Mariagrazia Felisi – mgfelisi@cvbf.net