ADaM Metadata Submission Guidelines v1.0

Published Date:

Version 1.0 of the Analysis Data Model Metadata Submission Guidelines (ADaM-MSG): Human Clinical Trials provides guidance for preparing the components of the International Conference on Harmonisation (ICH) electronic Common Technical Document (eCTD) Module 5 (M5) Clinical Study Reports "adam" folder. This document and the associated example submission package illustrate the components recommended for electronic submission of ADaM data for an individual study, but can be used as a template for integrated studies as well.

Public Review Comments

CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.