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Showing 7351–7360 of 17465 articles for “Art. Form 2044 spéciale”
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…
…of 5 April 2017 and persons admitted to a health or social establishment for purposes other than performance studies may be asked to take part in performance studies which do not involve any risk or c…
…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 which all the procedures are car…
…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 (EU) 2016/679 of t…
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…
I.-Natural persons guilty of the offence referred to in article L. 1126-20 shall also be liable to the following penalties: 1° Disqualification from civic, civil and family rights, in accordance with…
…U) 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 project for the opinion of a personal data protection c…
For each study of performance, with the exception of that which does not involve any risk or constraint and in which all the procedures are carried out and the products are used in the usual way, the…
The competent authority may, at any time, request additional information on the performance study from the developer. Where the competent authority considers that the requirements set out in Regulatio…
…ined the favourable opinion of a committee for the protection of individuals and, in the case of performance studies mentioned in the second to fifth paragraphs of II of Article L. 1126-1, the authori…
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