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Article D1123-36 of the French Public Health Code

The Chairman sets the agenda for the meetings. The Chairman informs the Director General for Health, who may request that new items be added to the agenda. Opinions are adopted by a simple majority of the members present and, in the event of a tied vote, the Chairman has the casting vote. The provisions of article R. 133-10 of the Code des relations entre le public et l’administration are applicable…

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Article R1123-38 of the French Public Health Code

The competent authority shall notify the sponsor of the date of receipt of the dossier and the date on which, in the absence of express authorisation, the research is deemed to have been authorised. If the dossier is not complete, the competent authority will notify the sponsor of a list of the missing documents and set a deadline for submission, after which the sponsor will be deemed to have withdrawn…

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Article R1123-39 of the French Public Health Code

If the research involving the human person has not begun within two years of authorisation, this authorisation lapses. However, if justification is provided before the expiry of this period, it may be extended by decision of the competent authority.

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Article R1123-40 of the French Public Health Code

The sponsor informs the competent authority and the Committee for the Protection of Individuals without delay of the effective date of commencement of the research, corresponding to the date on which the consent is signed by the first person to take part in the research in France.

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