Trial Start Up - Online Course

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


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.



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
  • Viviana Giannuzzi –
  • Betty Polikar –
  • Ana Dilo –
  • Mariagrazia Felisi –