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
