Enrolment will be open from 10th May 2021 – 30th April 2024

Name of the course: Monitoring Paediatric Trials

Edition of the course:  3rd Edition

Starting date: 10 May 2021

Closing date: 30th April 2024

Course Duration: 3 h

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:  

This short course has been developed and focused on Monitoring aspects of clinical trials. It describes the role of the monitor, the site staff responsibilities in clinical trial monitoring, monitoring plan and SOPs.

Programme:

• Module 1:  The role and responsibilities of the Monitor in a Clinical Trial.

• Module 2:  Monitor’s role during the study (routine and close out visits), monitor’s tasks in keeping contacts with sites and remote monitoring.

• Module 3:  Site staff responsibilities in clinical trial monitoring.

• Module 4: SOPs and Monitoring procedures Learning.

• Module 5: Monitoring Plan complying with GCP requirements.

• Module 6:  Safety monitoring.
  

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 the 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

Faculty:

• Loic Notelet – Loic.Notelet@sanofi.com

• Lucie Spatenkova – lucie.spatenkova@crc-cz.com

• Betty Polikar- betty.polikar@opbg.net

• Silvia Pulici – spulici@cvbf.net

• Cristina Manfredi – cmanfredi@cvbf.net