Student
Course
Management

Fundamentals of clinical studies: GCP & beyond (GCP)

The Clinical Trial Unit (CTU) organizes a comprehensive course on how to set-up, conduct and follow-up clinical studies, following Good Clinical Practice (ICH-GCP) guidelines as a reference.
In 2007, the Institute of Tropical Medicine was approved by Belgian authorities as a sponsor of clinical studies and since then the CTU has coordinated numerous non-commercial clinical studies, conducted in Belgium as well as overseas in Africa and Asia.
A dedicated team with expertise in clinical trial project management, monitoring, (bio)statistics, data management, research ethics and regulatory guidelines assures all trials are in line with ICH-GCP guidelines and (inter)national regulations for designing, conducting, recording and reporting trials that involve the participation of human subjects.

Mode of study

This course (component) is organized :
- Face-to-face (Antwerpen)

Learning Objectives

This course aims to give participants the relevant basic knowledge, understanding and tools to confidently and critically participate in and/or coordinate clinical studies.
Specifically, upon completion of this course participants should be able to:
• define the basic concepts of clinical research;
• define and discuss ethical principles in clinical research;
• plan a clinical study project from preparation to closure;
• apply Good Clinical Laboratory Practice principles within a clinical research laboratory;
• comply with safety and pharmacovigilance regulations in a clinical study;
• distinguish among various study designs and interpret statistical sections in study protocols and publications;
• understand and apply all aspects of data management processes in clinical studies.

Content

The course will consist of the following sessions:
Session 1:        Background, classification & definitions of interventional clinical research
Session 2:        Clinical project management: planning & preparation of a clinical study
Session 3:        Clinical project management: conduct & closure of a clinical study
Session 4:        Study design & statistical considerations
Session 5:        Safety & pharmacovigilance in clinical studies
Session 6:        Good Clinical Laboratory Practice
Session 7:        Ethics & Research Integrity in clinical research
Session 8:        Data management in clinical research  
 
Participants are invited to subscribe on-line to the full course (8 sessions, 900 EUR). The fee covers participation to the sessions, coffee breaks, lunch, training materials, course bag, certificate of attendance / GCP certificate (optional).
Pending availability of seats, participation  to a selection of sessions based on personal interest will be optional (200 EUR/session). Please contact the course secretariat (gcp@itg.be) should you be interested in this option.
RIZIV accreditation has been requested.

Teaching and learning methods

Throughout the course, a central theme will be used in each session with real life examples of a mock study which will be discussed as a starting point (case discussion, problem-based approach). In order to fully prepare for the course, all subscribed participants will receive the protocol and associated documents of this mock clinical study one week before the start of the course so they can get acquainted with the content of the mock study.

Assessment

All participants will receive a “certificate of attendance”, with mentioning of the sessions attended.
For participants who wish to obtain a GCP certificate, a formal examination (multiple choice quiz, covering aspects of all course sessions) will be held at the end of the course. In order to receive certification, an overall score of at least 70% should be achieved.

Admission requirements

This course is open to anyone interested to participate in the set-up and conduct of interventional studies in humans. No prior knowledge or experience about the topic is required, however this postgraduate course targets participants with either a bachelor degree, master degree or pre- and post-PhD students with a scientific background e.g. in Medicine, Biomedical Science, Pharmaceutical Science or a related human science degree. This course is especially of interest to clinical site team members (MD, study nurse, study coordinators, data managers, biostatisticians, …) as well as members of clinical trial units or clinical research organisations entering the field of clinical research or aiming to refresh and/or extend their knowledge in clinical research.
The course does NOT provide a technical training on e.g. database development or statistical programming/analysis.
Participants should be proficient in English, written and spoken.

Selection criteria

For organisational purposes, a maximum of 30 students is admitted.  Places are allocated on a "first-come, first-served basis". Participants applying for the full course of 8 sessions will be prioritized and can subscribe on-line using the application button on this page.

Contact

Course Leader: Yven Van Herrewege
Coordinator (s): Bart Smekens
Secretary: Danielle Van Melle
gcp@itg.be
Tel: +32(0)33455634
Fee & schedule >