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Showing 61–70 of 87 articles for “Art. 1125”
No clinical investigation may be carried out on a person without his free and informed consent, obtained in writing under the conditions laid down in paragraph 1 of Article 63 of Regulation (EU) 2017/…
Pursuant to Articles 62,70,74,75 and 82 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, before carrying out a clinical investigation, the sponsor shall submi…
At the time of giving informed consent, the investigator may ask the person undergoing clinical investigation to agree to his/her data being used in subsequent research for scientific purposes only. T…
When an unmarried couple or woman undergoing medically assisted procreation is asked to take part in research involving the human person carried out in the context of medically assisted procreation, t…
The sponsor shall report to the Agence nationale de sécurité du médicament et des produits de santé any suspected serious unexpected adverse reactions and any serious incidents occurring in France and…
For the purposes of this sub-section, the following definitions shall apply1° Adverse event: any harmful manifestation occurring in a donor, in a person who takes part in research involving the human…
The time limit for examining an application for a substantial amendment is set at thirty-five days from receipt of all the information required concerning this application.Where the Director General o…
Research involving the human person carried out in the context of medically assisted procreation means research which complies with the conditions laid down in Title II of Book I of Part One of this C…
When the research project is carried out in the context of medically assisted procreation, the Data Protection Committee shall call upon the expertise of at least one practitioner mentioned in the fif…
The sponsor reports every six months to the Data Protection Committee, in the form of a list accompanied by a summary, any suspected serious unexpected adverse reactions and serious incidents that hav…
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