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Showing 781–790 of 3182 articles for “Art. CE 28 Sep 2017 n° 409770”
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…
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…
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.…
…t has sole jurisdiction to rule on any action for compensation for damage resulting from a performance study. This action is time-barred under the conditions set out inarticle 2226 of the Civil Code.
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…
…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 protection…
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…
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…
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