Duration
Part I: First meeting class and reminder of basic principles adapted to the theme of clinical trials : 22h Th
Part II: Designing a clinical trial : 38h Th
Part III: Methodology of clinical trials : 16h Th
Part IV: Publishing results and Evidence Based Medicine : 6h Th
Part V: Translational research, pharmaco-epidemiology, biobanks and data management : 2h Th
Number of credits
| University certificate in clinical test (next session in 2023-2024) | 10 crédits |
Lecturer
Part I: First meeting class and reminder of basic principles adapted to the theme of clinical trials :
Part II: Designing a clinical trial :
Part III: Methodology of clinical trials :
Part IV: Publishing results and Evidence Based Medicine :
Part V: Translational research, pharmaco-epidemiology, biobanks and data management :
Coordinator
Language(s) of instruction
French language
Organisation and examination
All year long
Schedule
Units courses prerequisite and corequisite
Prerequisite or corequisite units are presented within each program
Learning unit contents
This is a certificate in clinical trials. A certificate meets the access conditions according to the decree. The subject taught concerns basic reminders in - preclinical research -general pharmacology - medical biology analyzes -toxicology -statistics -GMP -GCP. The certificate also addresses the methodology of clinical trials (interventional and observational), the implementation of a protocol from the start to the marketing of a drug as well as the concepts of translational research and biobanking. The ethical and legal matters surrounding clinical trials will not be forgotten Finally, the Luxembourg Health Institute will share its experience through its teachers. Finally the evidence based medicine (EBM) based on the publications of the results of clinical trials will be discussed. Given the Covid pandemic, the program could be modified according to the measures taken by the authorities.
Part I: First meeting class and reminder of basic principles adapted to the theme of clinical trials
Visible on the continuing education website with schedule, course title and location The rest is available on the slides of the first meeting class available on this site. For the rest please refer to the educational commitments of the whole module.
Part II: Designing a clinical trial
Visible on the continuing education website with schedule, course title and location The rest is available on the slides of the first meeting class available on this site. For the rest please refer to the educational commitments of the whole module.
Part III: Methodology of clinical trials
Visible on the continuing education website with schedule, course title and location The rest is available on the slides of the first meeting class available on this site. For the rest please refer to the educational commitments of the whole module.
Part IV: Publishing results and Evidence Based Medicine
Visible on the continuing education website with schedule, course title and location The rest is available on the slides of the first meeting class available on this site. For the rest please refer to the educational commitments of the whole module.
Part V: Translational research, pharmaco-epidemiology, biobanks and data management
Visible on the continuing education website with schedule, course title and location The rest is available on the slides of the first meeting class available on this site. For the rest please refer to the educational commitments of the whole module.
Learning outcomes of the learning unit
At the end of this certificate, the student must be able to understand, analyze and criticize a clinical trial. The expected learning is that of being able to be part of a clinical research team depending on the student's initial training and his professional experience acquired previously.
Prerequisite knowledge and skills
The prerequisites are those of the access conditions mentioned on the ULiege continuing education website
Planned learning activities and teaching methods
The learning will be done through lessons on site with a maximum of interactivity. Reference documents will be made available. Unit visits will be organized (subject to pandemic) and expert readings given. The lessons will be made available through the class delegate.
Mode of delivery (face to face, distance learning, hybrid learning)
Faca to face (modifications due to Covid can occur)
Recommended or required readings
Reference documents (scientific articles) will be given to students through the delegate.
Assessment methods and criteria
The course evaluation will be done by a written knowledge assessment. The internship will be evaluated by the internship supervisor and the TFE by a Jury. At least 50% reduction in each item required.
Work placement(s)
40-hour internship (5 consecutive days or 10 consecutive half-days / except experimental conditions that do not allow it. Internship project of the internship supervisor and commitment on the honor of the student to get involved must be previously validated by the promoter . All this is detailed during the first meeting class.
Organizational remarks
Due to the Covid pandemic, any modification is possible and students will be notified. It is not certain in this context that all unit visits (LIH, Janssen, ATC) are possible.
Contacts
Promoteur: regis.radermecker@chuliege.be
JRéférent LIH: Jonathan.Cimino@lih.lu