Month: March 2018

ACUTA, ARCS, ARIM, ARIM Publisher, FDA, Software Release, Validator

Getting your STF in order

In 2003, ICH introduced the Study Tagging File (STF) in the electronic Common Technical Document (eCTD) format for electronic submissions to facilitate a way to associate all the documents and data files for a study. Initially the specification included two possible approaches for versioning the study‚Äôs items: Cumulative: A complete cumulative STF would be provided …