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Showing 9891–9900 of 63870 articles for “Art. L 3332-14 and L 3332-26”
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.
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…
The committees are composed in such a way as to guarantee their independence and the diversity of their expertise in the field of research involving the human person and with regard to ethical, social…
The Minister for Health may withdraw the approval of a committee if the conditions of independence, composition or operation required to carry out its mission in the best possible conditions are no lo…
I.-The competent authority for the research involving the human person provided for in article L. 1121-1 is the Agence nationale de sécurité du médicament et des produits de santé (French National Age…
With a view to studying the risks associated with healthcare as part of their duties, the authorities, establishments and bodies on a list established by decree shall have access, at their request, to…
An observatory of medical risks is attached to the Office national d'indemnisation des accidents médicaux, des affections iatrogènes et des infections nosocomiales, the purpose of which is to analyse…
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