Brochure de l'investigateur-- Prüferinformation (zum Prüfpräparat)
A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.36; sec 7
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, art. 2 g;