SOCIAL QUESTIONS|health|medical science
- bróisiúr imscrúdaitheora Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- Information für den Prüfer
- de
- Nóta Term defined --
- IB | investigator's brochure
- en
- Sainmhíniú compilation of the clinical and non-clinical data on the investigational medicinal product or products which provides the investigators and others involved in the trial with information to facilitate their understanding of the rationale for, and their compliance with, key features of the protocol, such as the dose, dose frequency/interval, methods of administration, and safety monitoring procedures Tagairt COM-EN, based on:Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, CELEX:32014R0536/EN
- brochure pour l'investigateur
- fr
- Nóta Term defined --