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Showing 1911–1920 of 68978 articles for “Art. s. L. 145-1 to L. 145-60 + R. 145-1 to R. 145-38”
…that require immediate coffining in a sealed coffin, meeting the characteristics defined in Article R. 2213-27, and its closure; b) The list of transmissible infections that require immediate coffinin…
The investigator may ask the person taking part in a performance study, at the time he or she gives informed consent, to agree to his or her data being used in subsequent research exclusively for scie…
…its opinion on the conditions for the validity of the performance study, in particular with regard to : the protection of individuals, in particular the protection of participants; -the adequacy, com…
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…
…ion on the patient which is not justified by the patient's usual care and which exposes the patient to risks and constraints which are not minimal, the sponsor provides the in vitro diagnostic medical…
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…
…ll the procedures are carried out and the products are used in the usual way, the dossier submitted to the Committee for the Protection of Individuals and to the competent authority shall determine wh…
…uthority 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 Regulation (EU) No 2017/…
…ay only be carried out in a place which has the human, material and technical resources appropriate to the performance study and compatible with the safety requirements of the persons undergoing it. T…
…this consent shall be expressed by each of the holders of parental authority. If it is not possible to consult one of the holders of parental authority, the performance study may be carried out provid…
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