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Showing 261–270 of 12410 articles for “Art. L112-7”
I.-The competent authority for the research involving the human person provided for in article L. 1121-1 is the Agence nationale de sécurité du médicament et des produits de santé (French National Age…
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…
Carrying out or causing to be carried out a performance study in breach of Articles 59 to 62 of Regulation (EU) No 2017/746 of the European Parliament and of the Council of 5 April 2017 and Article L.…
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…
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…
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…
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