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Showing 221–230 of 12410 articles for “Art. L112-7”
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…
I.- Before carrying out research involving the human person, the sponsor submits the project for the opinion of a personal data protection committee designated at random from among the available commi…
Research involving the human person 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, wher…
For research, clinical investigations or performance studies covered by national defence confidentiality, the sponsor must notify the competent authority of all relevant information relating to the sa…
The sponsor is responsible for compensating for the harmful consequences of the clinical investigation for the person who takes part in it and for that of his successors, unless he can prove that the…
Notwithstanding article 13 of the law of 16 and 24 August 1790 on the organisation of the judiciary, the judicial court alone has jurisdiction to rule on any action for compensation for damage resulti…
For each type of research involving the human person, the investigator records the adverse events or abnormal analysis results defined in the protocol as decisive for the evaluation of safety, keeps a…
I.- For research, clinical investigations or performance studies involving national defence secrets, the sponsor submits the project for the opinion of a specific committee for the protection of indiv…
In the event of a refusal of validation provided for in paragraph 3 of Article 70 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, a refusal of authorisation…
For each clinical investigation with the exception of that which does not involve any risk or constraint and in which all the procedures are carried out and the products are used in the usual way, the…
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