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Showing 231–240 of 12410 articles for “Art. L112-7”
No clinical investigation may be carried out on a deceased person, in a state of brain death, without his or her consent expressed during his or her lifetime or through the testimony of his or her fam…
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 Minister for Health approves one or, as required, several personal protection committees for a fixed period. Their members are appointed by the Director General of the Regional Health Agency for t…
The members of the Committees, the persons called upon to collaborate in their work, and the agents covered by the general statute of civil servants or the general statute of military personnel who ar…
When the authority designated in article L. 1123-12 or in II of articles L. 1125-1 and L. 1126-1 does not have agents with the level of clearance required for national defence confidentiality, given t…
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…
Research may only be carried out under the following conditions:- under the direction and supervision of a doctor with appropriate experience ;- in material and technical conditions appropriate to the…
After the start of the research, any substantial modification of the research on the initiative of the sponsor must obtain a favourable opinion from the Committee prior to its implementation and, in t…
Subject to the provisions of this chapter, the provisions of chapters III, V and VI of this title apply respectively to research involving the human person, clinical investigations and performance stu…
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