Article L1125-26
In the context of a clinical investigation involving an intervention that is not justified by the patient's usual care and that involves risks and constraints that are not minimal, failure by the spon…
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Showing 5061–5070 of 60177 articles for “Art. L. 145-16-2 + Cass. 3e civ.”
In the context of a clinical investigation involving an intervention that is not justified by the patient's usual care and that involves risks and constraints that are not minimal, failure by the spon…
The competent authority may, at any time, request additional information on the clinical investigation from the sponsor. Where the competent authority considers that the requirements set out in Regula…
No research involving the human person may be carried out :- if it is not based on the latest scientific knowledge and on sufficient pre-clinical experimentation ;- if the foreseeable risk incurred by…
In the context of a performance study involving an intervention not justified by the usual management of the participant and entailing risks and constraints that are not minimal, failure by the sponso…
The provisions of Section 3 of Chapter III of Title II of Law No. 78-17 of 6 January 1978, as amended, relating to information technology, files and freedoms, as well as the provisions of Regulation (…
The profession of genetic counsellor may be practised by, and bear the title of, persons who hold evidence of formal qualifications appearing on a list drawn up by order of the Minister for Health. By…
As stated in Article 226-26 of the French Criminal Code, reproduced below: "The act of diverting information gathered on a person by means of an examination of their genetic characteristics from their…
The victim, or his heirs, has the right to take legal action against the Office if no offer has been made to him or if he has not accepted the offer made to him. The action for compensation is brought…
Accidents in everyday life are defined as all unintentional injuries, with the exception of road traffic accidents and accidents at work.
Therapeutic patient education programmes comply with national specifications, the content of which is defined by order of the Minister for Health, based on the recommendations and guidelines drawn up…
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