Trial Monitoring - Online Course

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

Name of the course: Trial Monitoring

Edition of the course:  3rd Edition

Starting date: 10 May 2021

Closing date: 30th April 2024

Course Duration: 3 h

 

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  procedures,  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 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

 

 

 

 

 

 

 

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