3 ECTS credits
90 h study time
Offer 1 with catalog number 4023148ENR for all students in the 1st semester at a (E) Master - advanced level.
Types of studies and their specific regulations
Liability in clinical studies
Conflict of interest
Changes in the regulatory landscape
Protocol_ design and development of clinical studies in healthy volunteers and patients
Informed Consent documents and procedures
Investigator’s Brochure
(Clinical Trial) Agreements, etc ...
Researcher
Study nurse
Monitor
Pharmacist
(Sponsor)
Trial Master File / Investigator’s Site File
Source documents and eCRF
Pharmacovigilance, DSUR, protocol deviations, CAPA, etc…
The principles of ICH-GCP
The responsibilities in a clinical study
PowerPoint presentations that are made available to the students via the digital learning platform.
Teaching material: Study protocol (s), templates study documents
REDCap: tool for data management will be made available for the self-study assignment
The final grade is composed based on the following categories:
Written Exam determines 60% of the final mark.
PRAC Practical Assignment determines 10% of the final mark.
SELF Practical Assignment determines 20% of the final mark.
Other determines 10% of the final mark.
Within the Written Exam category, the following assignments need to be completed:
Within the PRAC Practical Assignment category, the following assignments need to be completed:
Within the SELF Practical Assignment category, the following assignments need to be completed:
Within the Other category, the following assignments need to be completed:
The written exam (open questions and some multiple choice questions, without guess correction), the WPO, the two self-studies and the GCP-test count for 60, 10, 20 and 10 percent respectively in the final mark. Passing the GCP-test requires a score of at least 80%. The final grade will not be more than 9/20 when the student hasn’t passed the GCP-test. No resit is possible for the WPOs and self-studies.
This offer is part of the following study plans:
Master of Biomedical Sciences: Management and Business (only offered in Dutch)
Master of Biomedical Sciences: Clinical Biomedical Sciences (only offered in Dutch)
Master of Biomedical Research: Standaard traject
Master of Teaching in Health Sciences: standaard traject (120 ECTS, Etterbeek) (only offered in Dutch)
Master of Movement and Sports Sciences: Physical Activity, Fitness and Health Profile Profile Research (only offered in Dutch)