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.

Semester
1st semester
Enrollment based on exam contract
Impossible
Grading method
Grading (scale from 0 to 20)
Can retake in second session
Yes
Enrollment Requirements
Om een inschrijving te kunnen nemen voor 'Good Clinical Practice en klinische studies' moet men geslaagd zijn voor 'Kwaliteitsmanagement'. Studenten die instromen uit het verkort BMLT traject, gelieve de trajectbegeleider te contracteren voor de registratie voor dit opleidingsonderdeel : https://studenten.vub.ac.be/studietrajectbegeleiders.
Taught in
Dutch
Faculty
Faculteit Geneeskunde en Farmacie
Department
Basis (bio-) medische wetensch
Educational team
Catherine De Greef (course titular)
Activities and contact hours
24 contact hours Lecture
8 contact hours Seminar, Exercises or Practicals
20 contact hours Independent or External Form of Study
Course Content
  • Ethical and legal framework for clinical scientific research

Types of studies and their specific regulations

Liability in clinical studies

Conflict of interest

  • Role of ethics committee and regulatory authorities (FAMHP)

Changes in the regulatory landscape

  • Preparation of a clinical study: documents, tasks and responsibilities

Protocol_ design and development of clinical studies in healthy volunteers and patients

Informed Consent documents and procedures

Investigator’s Brochure

(Clinical Trial) Agreements, etc ...

  • Conducting a clinical study: tasks, responsibilities, delegation and documents

                       Researcher

                       Study nurse

                       Monitor

                       Pharmacist

                       (Sponsor)

  • Documents and archive: documents, tasks and responsibilities

Trial Master File / Investigator’s Site File

Source documents and eCRF

  • Reporting: what - to whom – when

Pharmacovigilance, DSUR, protocol deviations, CAPA, etc…

  • Audits and inspections, accreditations
  • Multicenter research - sponsor responsibilities
  • GCP training leading with GCP certificate (UZ Clinical Trial Center)

The principles of ICH-GCP

The responsibilities in a clinical study

  • Clinical research at the UZ Brussel / at the VUB
Course material
Digital course material (Required) : Powerpoint presentatie, Canvas
Additional info

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

Learning Outcomes

Algemene competenties

  • The student has knowledge of the regulations regarding clinical research and insight into the practical preparation and execution of clinical studies.
  • The student has an understanding of the ethical aspects in the context of clinical research.
  • The student understands the content of a study protocol and can translate this into a Case Report Form.
  • The student has obtained a valid GCP certificate.

Grading

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:

  • schriftelijk examen with a relative weight of 60 which comprises 60% of the final mark.

Within the PRAC Practical Assignment category, the following assignments need to be completed:

  • WPO with a relative weight of 10 which comprises 10% of the final mark.

Within the SELF Practical Assignment category, the following assignments need to be completed:

  • 2 zelfstudies with a relative weight of 20 which comprises 20% of the final mark.

Within the Other category, the following assignments need to be completed:

  • GCP-test with a relative weight of 10 which comprises 10% of the final mark.

Additional info regarding evaluation

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.

Allowed unsatisfactory mark
The supplementary Teaching and Examination Regulations of your faculty stipulate whether an allowed unsatisfactory mark for this programme unit is permitted.

Academic context

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)