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Showing 231–240 of 52251 articles for “Art. L112-1”
Subject to the provisions of this chapter, the provisions of chapters III, V and VI of this title apply respectively to research involving the human person, clinical investigations and performance stu…
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…
Where research is carried out at the Institution nationale des invalides or in a health establishment or army hospital with an in-house pharmacy, failure by the sponsor to notify the pharmacist in cha…
Failure to comply with Articles 37, 42, 43 and 93 of European Parliament Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products regarding the communication of informatio…
The works or service concession contracts and defence or security concession contracts defined in this Title are subject to the provisions of Part Three.
No research mentioned in 1° of Article L. 1121-1 may be carried out on a person without their free and informed consent, obtained in writing, after they have been given the information provided for in…
I.-For the duration of the research referred to in 1° of article L. 1121-1, the sponsor provides free of charge the investigational medicinal products and, where applicable, the ancillary medicinal pr…
I. - A National Commission for Research Involving the Human Person, responsible for coordinating, harmonising and evaluating the practices of the Committees for the Protection of Individuals, has been…
In the case of research involving the human person mentioned in 2° of Article L. 1121-1 , the methodological requirements of which are not compatible with obtaining consent under the conditions provid…
Persons who are not affiliated to a social security scheme or who are beneficiaries of such a scheme may be asked to take part in non-interventional research. By way of derogation, the Personal Data P…
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