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Showing 261–270 of 14565 articles for “Art. L112-6”
Any substantial modification at the initiative of the sponsor of a research project, clinical investigation or performance study covered by national defence confidentiality must obtain, prior to its i…
The investigator may ask the person taking part in a performance study, at the time he or she gives informed consent, to agree to his or her data being used in subsequent research exclusively for scie…
Notwithstanding article 13 of the law of 16 and 24 August 1790 on the organisation of the judiciary, the judicial court has sole jurisdiction to rule on any action for compensation for damage resultin…
The promoter is responsible for compensating for the harmful consequences of the performance study for the person taking part in it and their dependants, unless it can prove that the damage is not att…
Where a performance study is conducted at the Institution nationale des invalides or in a health establishment or army hospital with an in-house pharmacy, failure by the promoter to communicate in adv…
It is punishable by one year's imprisonment and a fine of 15,000 euros to carry out or cause to be carried out research involving the human person: 1° Without having obtained a favourable opinion from…
Failure by the sponsor to provide the investigators of chemical, pharmaceutical, biological, pharmacological or toxicological tests with the information required by law relating to the test, the medic…
The performance study does not give rise to any direct or indirect financial compensation for the persons taking part, apart from the reimbursement of expenses incurred and, where applicable, compensa…
The procedures for applying the provisions of this chapter shall be determined by decree in the Conseil d'Etat and in particular: 1° The procedures applicable to the coordinated assessment procedure d…
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…
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