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Showing 121–130 of 151 articles for “Art. 1123”
For all research involving humans, the sponsor must pass on to the investigators concerned any information likely to affect the safety of individuals.
The investigator notifies the sponsor without delay from the day on which he becomes aware of all serious adverse events and all adverse reactions and serious incidents occurring in the course of rese…
For research involving medicinal products, the Director General of the Agence nationale de sécurité du médicament et des produits de santé ensures that all suspected serious unexpected adverse reactio…
With the exception of research requiring express authorisation, if the competent authority does not respond to a request for substantial modification from the sponsor, this will be deemed to constitut…
Within one year of the end of the research involving the human person or its interruption, a final report is drawn up and signed by the sponsor and the investigator, and in the case of multicentre res…
The provisions of this section apply without prejudice to the provisions of articles R. 1221-22 to R. 1221-52 relating to haemovigilance.
Within ninety days of the end of the research involving human subjects, the sponsor must inform the competent authority and the relevant data protection committee of the effective date of the end of t…
When research involving the human person is conducted in a health establishment, the sponsor must inform the director of the establishment in advance of the research, for information purposes:1° The t…
The competent authority shall inform without delay the Committee for the Protection of Individuals and the National Commission for Research Involving the Human Person and, for the research mentioned i…
The documents and data relating to the research are kept by the sponsor and the investigator for a period set by order of the Minister for Health issued on a proposal from the Director General of the…
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