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Showing 9491–9500 of 18228 articles for “Art. 5° ter”
…s and constraints involved in performance studies, that the persons taking part should also be registered in this file.
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…
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…
Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Art…
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…
The provisions of Section 3 of Chapter III of Title II of Law No. 78-17 of 6 January 1978, as amended, relating to information technology, files and freedoms, as well as the provisions of Regulation (…
Before a performance study is carried out, information is given to the person taking part by the investigator or by a doctor representing him. Where the investigator is a qualified person, this inform…
…the offence defined in article L. 1126-20 shall incur, in addition to a fine in accordance with the terms and conditions set out inarticle 131-38 of the French Criminal Code, the penalties set out in…
Pursuant to Articles 58,66 and 70 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017, before carrying out a performance study, the sponsor shall submit the proje…
…submitted to the Committee for the Protection of Individuals and to the competent authority shall determine whether it is necessary for the person not to be able to participate simultaneously in any o…
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