Investigator Brochure Template Ema

7 1 introduction the investigator s brochure ib is a compilation of the clinical and nonclinical data on the investigational product s that are relevant to the study of the product s in human subjects.

Investigator brochure template ema. Although the ib also serves other purposes it is primarily written to enable investigators conducting clinical studies to assess the risks and benefits associated with an investigational product. This document addresses the good clinical practice an international ethical and scientific quality standard for designing conducting recording and reporting trials that involve the participation of human subjects. Good clinical practice e6 r1. The investigator s brochure ib is a multidisciplinary document that summarises the main elements of an entire development programme to date.

Investigator s brochure guideline 10 july 2002 3 introduction the investigator s brochure ib is a compilation of all relevant nonclinical and clinical data for a drug undergoing clinical investigation. The investigator s brochure is a compilation of non clinical and clinical data relevant to the study of the medicine in humans it is the single most comprehensive document summarising the information on an investigational medicinal product. In the absence of detailed guidance or a template for the content of the investigator s brochure ib for advanced therapeutic medicinal product atmp development quality this document has been created as an authoring guide. Is based on the ema guideline.