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Showing 21–30 of 43 articles for “Art. 1124”
…cle L. 1123-7 solely with regard to the requirements mentioned in the third paragraph of Article L. 1124-1.
…with Article L. 1121-4 or without having obtained the single decision mentioned in I of Article L. 1124-1 ; 2° Under conditions contrary to the provisions of article L. 1121-12 ; 3° Whose performance…
I.- Clinical trials of medicinal products are governed by the provisions of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014. The competent authority for carr…
At the request of the Committee for the Protection of Individuals, the sponsor or his representative appointed for this purpose, possibly accompanied by the investigator or, where appropriate, the coo…
The Committees for the Protection of Individuals forward their unfavourable opinions to the National Commission for Research Involving the Human Person for information.
For requests for substantial changes to the list of investigation sites or principal investigators, the Chairman issues the opinion on behalf of the Committee on the proposal of a single rapporteur.
The sponsor of a clinical trial, whose application has been submitted under the conditions provided for in 1 of Article 98 of the above-mentioned Regulation of 16 April 2014, may inform the designated…
The sponsor of a clinical trial which consists of the extension of a previous trial may inform the designated personal data protection committee within twenty-four hours that this trial is linked to a…
When an application for a substantial amendment to an initial clinical trial is submitted, the competent Committee for the Protection of Individuals shall carry out the Part II assessment provided for…
When the Committee for the Protection of Individuals examines an application for a substantial amendment, the Committee may provide the competent authority with ethically-related comments on elements…
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