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Showing 7721–7730 of 66237 articles for “Art. III and IV”
…e made to the procedures for carrying out the research or to any document relating to the research, and may suspend or prohibit the research. Except in cases of imminent risk, a modification of the pr…
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.
…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 competence to examine the project…
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…
…nvestigator records the adverse events or abnormal analysis results defined in the protocol as decisive for the evaluation of safety, keeps a documentary record of them and notifies them to the sponso…
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…
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…
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…
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