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Showing 1231–1240 of 12461 articles for “Art. legal committee”
…composition and conditions of approval, financing, operation and appointment of the members of the Committees for the Protection of Individuals, as well as the nature of the information that must be…
…r has been given the opportunity to present its observations. The sponsor must inform the competent Committee for the Protection of Individuals and the competent authority referred to in Article L. 11…
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.
…ing the human person, the sponsor submits the project for the opinion of a personal data protection committee designated at random from among the available committees and having the necessary competen…
…earch project involving a medicinal product which has been granted a marketing authorisation to the Committee for the Protection of Individuals for an opinion, it shall give the opinion referred to in…
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…
…fication of the research on the initiative of the sponsor must obtain a favourable opinion from the Committee prior to its implementation and, in the case of research mentioned in 1° of Article L. 112…
I.- The committee gives its opinion on the conditions for the validity of the research, particularly with regard to :-the protection of individuals, in particular the protection of participants ;the a…
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