Module 12 2019

Resources

• in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials -Public consultation finished in July 2017 • International Conference on Harmonisation Good Clinical Practice Guidelines (ICH E6) • United States (US) 21 Code of Federal Regulation (CFR) 312 • European Union (EU) Clinical Trials Directive and GCP Directive (2001/2/0/EC and 2005/28/EC) • EMA/15975/2016 • EMA Recommendation on the content of the Trial Master File and archiving July 2006 • Clinical Trials Regulation (No. 536/2014)

The Organisation for Professionals in Regulatory Affairs