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Showing 21–30 of 151 articles for “Art. 1123”
Any change concerning the information mentioned inarticle R. 1123-1 is communicated by the Chairman of the Committee to the Director General of the Regional Health Agency.
The Committee gives its opinion under the conditions set out in Article R. 1123-23. If the Committee's opinion is unfavourable, the sponsor may not implement the modification to the research.
…entation and the content of the request for modification of the research provided for in article L. 1123-9 , the clinical investigation provided for in article L. 1125-3 or the performance study provi…
…estigator(s). These records shall be transmitted to the competent authority mentioned in Article L. 1123-12, at its request.
In application of the third paragraph of article L. 1123-11, except in the case of imminent risk, the sponsor has a period of one week in which to submit its observations from receipt of the request t…
…l of the Regional Health Agency will replace the member under the conditions laid down inarticle R. 1123-8.
For the research mentioned in 1° of Article L. 1121-1 other than that mentioned in Articles R. 1123-54 to R. 1123-58, the sponsor must report to the competent authority any suspected serious unexpecte…
The competent authority defined in Article L. 1123-12 implements the vigilance system relating to research involving the human person. Where necessary, it shall take appropriate measures to ensure the…
…the human person :1° The protocol for research involving the human person referred to in Article R. 1123-20 ; 2° Where applicable, the pharmaceutical form, batch number(s) and expiry date of the medic…
…form, content and procedures for reporting adverse reactions and new facts as defined in Article L. 1123-10 and, where applicable, the procedures for lifting the blind shall be laid down by decision o…
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