Zdrowie i gospodarka · 17/08/1995
International Conference on Harmonisation; Draft Guideline on Good Clinical Practice; Availability
The Food and Drug Administration (FDA) is publishing a draft guideline entitled ``Good Clinical Practice.'' This guideline was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guideline is intended to define ``Good Clinical Practice'' and to provide a unified standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.