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Showing 251–260 of 43820 articles for “Art. L112-2”
Research organised and carried out on human beings with a view to developing biological or medical knowledge is authorised under the conditions set out in this Book and is hereinafter referred to as "…
No one may impose restrictions on the rights of individuals or on individual and collective freedoms that are not justified by the nature of the task to be performed or that are not proportionate to t…
No one may carry out any research mentioned in 1° of Article L. 1121-1 without authorisation from the competent authority issued within a period set by regulation.If the competent authority informs th…
Clinical investigations may only be carried out in a place that has the human, material and technical resources appropriate to the clinical investigation and compatible with the safety requirements of…
I.-The Data Protection Committee gives its opinion on the conditions for the validity of the clinical investigation, particularly with regard to :the protection of individuals, in particular the prote…
Research may only be carried out in a place that has the human, material and technical resources appropriate to the research and compatible with the safety requirements of the persons undergoing the r…
The competent authority may, at any time, ask the sponsor for additional information about the research. If there is a risk to public health or if the sponsor fails to respond, or if the competent aut…
If the research is to be carried out in one or more public or private establishments, the sponsor must inform the director(s) of these establishments before the research is carried out.
The clinical investigation does not give rise to any direct or indirect financial compensation for the persons who take part in it, apart from the reimbursement of expenses incurred and, where applica…
Research involving the human person and the results thereof, with the exception of those relating to national defence secrets, are entered in a public access register in accordance with rules laid dow…
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