Clinical research : The term "research" refers to a category of activities aimed at building or enriching generalizable knowledge. Generalizable knowledge refers to the theories, principles or correlations, or the accumulation of information on which they are based, verifiable by proven scientific methods of observation and deduction. In this context, this term covers both medical and behavioural studies related to human health. Generally, the word "research" is accompanied by the epithet "biomedical" to indicate that these are health-related studies (CIOMS).
Clinical research can also be called "study" or "experimentation".
Sponsor : The Belgian Law of 7 May 2004 on experiments on human beings (as well as the European Directive 2001/20 EC) stipulates that, for each experiment, there must be a sponsor. The sponsor is a person, company, institution or organization responsible for the launch, management and/or financing of an experiment (Law 7 May 2004 Article 2-21°); the sponsor exercises the intellectual property rights on the design of the experiment, its execution and the resulting scientific data. There may be only one sponsor for an experiment. A study sponsor is different from a student dissertation sponsor.
Investigator : A physician or any other person practising a profession covered by Royal Decree No. 78 of 10 November 1967 on the exercise of healthcare professions, qualified to conduct an experiment. The investigator is responsible for conducting the experiment on a site. If, on a given site, the experiment is carried out by a team, the investigator is the director in charge of the team and the latter may be designated as the principal investigator (Law 7 May 2004 on experiments on human beings - Article 2-17°). The principal investigator is responsible for the local organisation of a clinical trial. This responsibility is both medical and legal. It is carried out with regard to the sponsor, institution, participant and ethics committee.
Protocol : A document describing the objective(s), design, methodology, statistical aspects and organization of an experiment. The term protocol covers the original protocol as well as its successive versions and amendments (Law 7 May 2004 and 7 May 2004 Article 2-22°).
DIFFERENT TYPES OF STUDIES
Studies may be interventional prospective, non-interventional prospective, retrospective or on human body material.
To help you determine the type of study for your project, consult the flowchart here below :
Interventional prospective studies : any study for which the risk for the participant is higher than the minimal risk of routine treatment (known as "standard of care" or "SOC").
We talk about an interventional study if:
- Intentional contact with the patient takes place in the context of organised research, even if the data collected are only processed/used in a study and/or subsequent publication (e.g. a questionnaire to be completed at home, telephone follow-up).
- There is a departure from routine practice and additional effort is required from the patient (e. g. additional diagnostic or monitoring procedure, additional blood test or collection of an additional blood tube during a routine test).
Interventional prospective studies may therefore concern a drug clinical trial, a study of a medical device or any other study requiring non-routine treatment or follow-up.
Non-interventional (observational) prospective studies : any study that does not require additional action to routine treatment or follow-up procedures; in this case it is a matter of observing one or more treatments or responses to standard treatments.
Studies involving only questionnaires for participants in a study, completed during routine consultation or follow-up, are considered non-interventional.
Interventional and non-interventional prospective studies fall within the scope of the Law of 7 May 2004 on human experimentation: a participant's consent and no-fault insurance are therefore part of the study's submission to the ethics committee.
Registries: a systematic collection of [health] data of an epidemiological and/or scientific nature, in the form of an organized system of data collected on the basis of defined criteria, relating to the field concerned, allowing a population of persons to be characterized in a longitudinal perspective.
The purpose of the registry is preparatory processing for subsequent research and analysis in the epidemiological and/or scientific field. Data from the registry may be used by duly authorized persons to facilitate recruitment for studies or to carry out retrospective studies with the following objectives: to understand or better treat the disease, to participate in the evolution of the quality of care, treatments, the cost of care for the disease, etc... These studies must be submitted to the Ethics Committee
Retrospective studies : any study for which the analysed data are already available at the time of the ethics committee's approval. These are mainly analyses of patients' medical records. In this case, no other data is acquired prospectively. This type of study does not require insurance and, if the consent of the participant whose data are being processed is too difficult to obtain, an exception to the requirement to obtain consent may be granted by the ethics committee.
Human body material studies : any study for which the analysed data are already available at the time of the ethics committee's approval. These are mainly analyses of patients' medical records. In this case, no other data is acquired prospectively. This type of study does not require insurance and, if the consent of the participant whose data are being processed is too difficult to obtain, an exception to the requirement to obtain consent may be granted by the ethics committee.
Regulatory requirements depend on the type of data collected with human body material:
- If prospective data are associated, the study becomes prospective and requires participant consent and insurance.
- If retrospective data are associated, the study is considered retrospective.
- If only the identification data of the human body material are necessary for the study (age, sex, pathology), the regulatory requirements depend on the law of 19/12/2008 on human body material: in this case neither insurance nor consent (opting out principle, or which does not say consent) is be required but it is mandatory to check the absence of refusal in the medical file before using any the material.
Residual human body material intended for research purposes is recorded in the CUSL biobank. Any transfer of this material to an external entity requires the establishment of an agreement between these two entities (Material Transfer Agreement).
All relevant information about human body material is available via this HBMR link : HBMR.
Student dissertation: the type of acts or analyses carried out defines the type of study.
INITIAL SUBMISSION OF STUDIES BY THE CENTRAL DESKS
Any clinical study requires a sponsor and principal investigator and must be pre-approved by the ethics committee.
In order to facilitate study submissions to the ethics committee, the Clinical Trial Center has central desks, which are the only access points to the ethics committee for the initial submission of clinical studies.
The desk handling the submission file depends on the type of promoter - the diagram below gives access to the page of the central desk concerned. The practical information and documents required for each type of study are detailed by desk in the corresponding pages.
Cliniques universitaires Saint-Luc
|Academic Study UCLouvain
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Update : September 2023