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Showing 6511–6520 of 33744 articles for “Art. III”
No one may carry out any research mentioned in 1° of Article L. 1121-1 without authorisation from the competent authority issued within a period set by regulation.If the competent authority informs th…
The procedures for applying the provisions of this chapter are determined by decree in the Conseil d'Etat, and in particular : 1° The composition and conditions of approval, financing, operation and a…
The competent authority may, at any time, ask the sponsor for additional information about the research. If there is a risk to public health or if the sponsor fails to respond, or if the competent aut…
If the research is to be carried out in one or more public or private establishments, the sponsor must inform the director(s) of these establishments before the research is carried out.
When the National Agency for the Safety of Medicines and Health Products, the High Authority for Health, the Minister for Health or the European Medicines Agency refers a non-interventional research p…
For each type of research involving the human person, the investigator records the adverse events or abnormal analysis results defined in the protocol as decisive for the evaluation of safety, keeps a…
The Minister for Health approves one or, as required, several personal protection committees for a fixed period. Their members are appointed by the Director General of the Regional Health Agency for t…
The members of the Committees, the persons called upon to collaborate in their work, and the agents covered by the general statute of civil servants or the general statute of military personnel who ar…
After the start of the research, any substantial modification of the research on the initiative of the sponsor must obtain a favourable opinion from the Committee prior to its implementation and, in t…
…health. The Committee will give its opinion on the basis of the information contained in this file.III. - The protocol submitted by the sponsor of research mentioned in 1° or 2° of Article L. 1121-1…
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