DefinitionInNationalLaw object

Definition in national law

Provided is not an official definition of interventional trials in France but an explanation:
Regulatory rules are similar for all categories of studies, excepted for observational studies. Studies are considered as observational only when participants are just observed. If there is any exam performed, such as blood or urine sampling, body composition or energy expenditure measurement, which is not included in the usual management, the study is considered as interventional (even without any nutritional or pharmaceutical intervention).

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