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Showing 241–250 of 43820 articles for “Art. L112-2”
Prior to the performance of research involving the human person, information is provided to the person participating in the research by the investigator or by a doctor representing the investigator. W…
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 clinical investigations which do not involve any risk or constraint. B…
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 performance studies which do not involve any risk or constraint and in…
As stated in article 223-8 of the Criminal Code, reproduced below: "The fact of carrying out or having carried out on a person the research mentioned in 1° or 2° of article L. 1121-1 or a clinical tri…
For each type of research involving the human person, the investigator records the adverse events or abnormal analysis results defined in the protocol as decisive for the evaluation of safety, keeps a…
I.- Clinical trials of medicinal products are governed by the provisions of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014. The competent authority for carr…
I.-The clinical investigations of the devices mentioned in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 are governed by the provisions of the afo…
The procedures for applying the provisions of this chapter are determined by decree in the Conseil d'Etat, and in particular : 1° The composition and conditions of approval, financing, operation and a…
I.-For the duration of the clinical investigation involving an intervention on the patient which is not justified by the patient's usual care and which exposes the patient to risks and constraints whi…
I.-For the duration of the performance study involving an intervention on the patient which is not justified by the patient's usual care and which exposes the patient to risks and constraints which ar…
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