The sponsor shall keep detailed records of all adverse events notified to it by the investigator(s). These records shall be transmitted to the competent authority mentioned in Article L. 1123-12, at its request.
The sponsor shall keep detailed records of all adverse events notified to it by the investigator(s). These records shall be transmitted to the competent authority mentioned in Article L. 1123-12, at its request.
Le promoteur tient des registres détaillés de tous les événements indésirables qui lui sont notifiés par le ou les investigateurs. Ces registres sont transmis à l’autorité compétente mentionnée à l’article L. 1123-12, à sa demande.
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is a Registered Trademark of
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182, rue de Rivoli
75001, Paris France
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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