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Showing 1111–1120 of 3346 articles for “Art. 22 nov. 2017”
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…
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…
…dures applicable to the coordinated assessment procedure described in Article 74 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017; 2° The conditions applicable…
…for this control. They are subject to professional secrecy under the conditions defined by articles 226-13 and 226-14 of the French Penal Code.
With a view to the application of the provisions of the first paragraph of article L. 1126-9 and article L. 1126-10, a national file shall be kept of persons who are free from any disease and who volu…
…oned in article L. 162-1-7 of the same code or hospitalisation services mentioned in article L. 162-22-6 of this code, when they are used as part of a non-commercial performance study authorised under…
In the context of a performance study involving an intervention not justified by the usual management of the participant and entailing risks and constraints that are not minimal, failure by the sponso…
…icles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article 60 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 and persons admitted to a hea…
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