for Category C clinical trials of medicinal products: the Investigator's Brochure (IB);
5.12.2 The sponsor should update the Investigator's Brochure as significant new information becomes available (see 7.
5.12.2 The sponsor should update the Investigator’s Brochure as significant new information becomes available (see 7.
5.12.2 The sponsor should update the Investigator’s Brochure as significant new information becomes available (see 7.
5.12.2 The sponsor should update the Investigator's Brochure as significant new information becomes available (see 7.
Investigator's Brochure (IB), only concerning changes in the administration of the medicinal product;
8.3.1 Investigator’s brochure updates To document that investigator is informed in a timely manner of relevant information as it becomes available X X
8.2.1 Investigator’S brochure To document that relevant and current scientific information about the investigational product has been provided to the investigator X X
4.4.2 As part of the investigator's/institution’s written application to the IRB/IEC, the investigator/institution should provide the IRB/IEC with a current copy of the Investigator's Brochure.
4.4.2 As part of the investigator’s/institution’s written application to the IRB/IEC, the investigator/institution should provide the IRB/IEC with a current copy of the Investigator’s Brochure.
8.2.1 Investigator’S brochure To document that relevant and current scientific information about the investigational product has been provided to the investigator X X
The first subparagraph shall apply also to any update of the investigator’s brochure.
8.2.1 Investigator’S brochure To document that relevant and current scientific information about the investigational product has been provided to the investigator X X
These requirements shall also apply to any update of the investigator's brochure.
8.3.1 Investigator’s brochure updates To document that investigator is informed in a timely manner of relevant information as it becomes available X X
Requêtes fréquentes français :1-200, -1k, -2k, -3k, -4k, -5k, -7k, -10k, -20k, -40k, -100k, -200k, -500k, -1000k,
Requêtes fréquentes anglais :1-200, -1k, -2k, -3k, -4k, -5k, -7k, -10k, -20k, -40k, -100k, -200k, -500k, -1000k,
Traduction Translation Traducción Übersetzung Tradução Traduzione Traducere Vertaling Tłumaczenie Mετάφραση Oversættelse Översättning Käännös Aistriúchán Traduzzjoni Prevajanje Vertimas Tõlge Preklad Fordítás Tulkojumi Превод Překlad Prijevod 翻訳 번역 翻译 Перевод