(refer to submission package and procedure for Experiments)
An experiment is defined as “Every clinical trial, study or research performed on humans, with the intention to gain knowledge inherent to the execution of healthcare professions as defined in Royal Decree n ° 78 of November 10, 1967 on the execution of health professions”.
- Interventional research: every research on humans that deviates from normal standard diagnostics or standard therapeutic care. For example: questionnaires or interviews, extra blood sampling, extra RX, psychotherapy, diet intervention, rehabilitation treatment, …
- Prospective observational research: research in which only healthcare data will be collected in the future, and epidemiological methods are used for the analysis of the results obtained.
For these studies, approval from the Medical Ethics Committee (MEC) is mandatory.
(refer to submission package and procedure for Clinical trials)
A clinical study means any investigation in relation to humans intended:
- to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products; or
- to identify any adverse reactions to one or more medicinal products; or
- to study the absorption, distribution, metabolism and excretion of one or more medicinal products;
with the objective of ascertaining the safety and/or efficacy of those medicinal products.
A clinical trial is a category of a clinical study. A clinical trial means a clinical study which fulfills any of the following conditions:
- the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice of the Member State concerned; or
- the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study; or
- diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects.
For these clinical trials, approval from both the Independent Ethics Committee (IEC) and Competent Authority (CA) (which is the Federal Agency of Medicines and Health Products (FAMHP) for Belgium) is mandatory.