Fundamentals of Clinical Studies: GCP & beyond
This face-to-face 5-day course provides the fundamental knowledge, understanding and tools you need to participate in and/or coordinate clinical studies.
Deadline: 30 april 2023
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.
This face-to-face 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;
• plan a clinical study project from preparation to closure;
• apply Good Clinical Laboratory Practice principles within a clinical research laboratory;
• understand aspects related to Research Integrity & Data Protection;
• 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.