Analysis Data Reviewer's Guide
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.
|Susan Kenny||Industry Co-Lead||Amgen||susan.kenny (at) amgen.com|
|Gail Stoner||Industry Co-Lead||Johnson & Johnson||GStoner (at) its.jnj.com|
|Mina Hohlen||FDA Observer||FDA||mina.hohlen (at) fda.hhs.gov|
Provide project updates in this section.
Objectives and Timelines
|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