Analysis Data Reviewer's Guide

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Analysis Data Reviewer's Guide Final Work Package


Version Release Date Downloadable Work Package Changes from Previous Version
v1.1 26-Jan-2015 ADRG Package v1.1 2015-01-26
  • Added ADSL Header to Section 5.2
  • Improved ADRG Template usability
  • Minor revisions to instructions in ADRG Completion Guidelines
  • ADRG Examples updated to match revised SDRG Template
v1.01 13-May-2014 ADRG Package v1.01 2014-05-13 Initial Version


Project Overview

ADaM “provides a framework that enables analysis of the data, while at the same time allowing reviewers and other recipients of the data to have a clear understanding of the data’s lineage from collection to analysis to results. Although ADaM provides a robust metadata framework, FDA Reviewers benefit from additional, human-readable, documentation of analysis methods, datasets, and programs that cannot be fully explained within the ADaM metadata. The development of an Analysis Data Reviewer’s Guide (ADRG) template will ensure this documentation is provided to the agency in consistent and usable format.

Project Leads

Name Role Organization E-mail
Susan Kenny Industry Co-Lead Independent susankenny (at) maxlikelihodd.com
Gail Stoner Industry Co-Lead Johnson & Johnson GStoner (at) its.jnj.com
Mina Hohlen FDA Liaison FDA mina.hohlen (at) fda.hhs.gov
John Brega Work Package Maintenance PharmaStat JBrega (at) pharmastat.com

Objectives and Timelines

Objective Timeline
Determine the scope of the ADRG (e.g. analysis datasets, programs, overlap with SDRG) Complete during CSS
Develop draft ADRG template and completion instructions 2 months
Vet draft ADRG template and completion instructions 1 month
Finalize draft ADRG template and completion instructions and develop ADRG examples 3 months
Release ADRG work package for public comment 1 month
Finalize ADRG work package and release for use 1.5 months

Project Content and Activities

PhUSE Conference Brussels 2013 Presentation: At the PhUSE conference in October 2013 a presentation was made on the status of the ADRG project. The slides from this presentation are attached: File:CSS Working Group Slides - ADRG.pdf

Meeting Minutes

ADRG Minutes 2013
CSS Meeting March 18-19, 2013

Archived Content