Module 12 2019

What are Document Standards?

Supports standard content ● ICH section headings

RA as Instructors

– Documents follow CTD section – Granularity ● ICH guidance text

– Module 2 summaries – Module 3 documents

– Module 4 study reports – Module 5 study reports ● May include “Boiler-plate text

The Organisation for Professionals in Regulatory Affairs