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Showing 281–290 of 43820 articles for “Art. L112-2”
The provisions of Articles 72, 75, 76, 77, 80, 87, 88, 89 and 90 of the aforementioned Regulation (EU) shall apply to the clinical investigations provided for in paragraph 1 of Article 82 of Regulatio…
At the time of giving informed consent, the investigator may ask the person undergoing clinical investigation to agree to his/her data being used in subsequent research for scientific purposes only. T…
No research may be carried out on a deceased person in a state of brain death without their consent expressed during their lifetime or through the testimony of their family. However, if the deceased p…
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…
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…
I.-The Data Protection Committee will give its opinion on the conditions for the validity of the performance study, in particular with regard to : the protection of individuals, in particular the prot…
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…
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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