PhUSE Archived Projects

Project Title	Working Group	Final Deliverable	Concluded
Alternative Transport for the Next Generation	Emerging Trends & Technologies	PhUSE White Paper	2017
Application of SEND Data for Analysis	Nonclinical Topics	PhUSE White Paper	2015
Best Practices for Metadata Documentation: Define XML vs Reviewers Guide	Optimizing the use of Data Standards	White Paper	2019
Biomarkers	Poster and white paper	Investigating Endpoint Modeling - Biomarkers
Challenges of Integrating and Converting Data across Studies	Optimizing the Use of Data Standards	Short Version of Integration	2012
Clinical Endpoint predictivity	Activities completed	NICE: Nonclinical data Interconnectivity for Clinical Endpoint predictivity
Clinical Trials Data as RDF	Emerging Trends & Technologies	PhUSE White Paper	2019
Data Validation and Quality Assessment	Optimizing the Use of Data Standards	Validation Rules	2013
Development of Standard Scripts for Analysis and Programming	Standard Analyses & Code Sharing	Reformed the Working Group	2013
Emerging Technologies	IG search tool (to add link)	Emerging Technologies Collaboration
Future Forum Interoperability & Technology	Emerging Trends & Technologies	N/A	2017
Histopathology Visualization	Deliverables	Visualization of Group Related Differences in Histopatholgy Data
Historical Controls	Completed tasks	Nonclinical Historical Controls
Industry Discussion	See project page for comments accumulated	Nonclinical Working Group Industry Discussion Group
Interorganizational SEND	Accomplishments	Interorganizational SEND
Introduction to Clinical Development Design (CDD) Framework	Emerging Trends and Technologies	2018 DIA Poster: The Clinical Development Design (CDD) Framework-Assisting and Improving Decision-Making for Product Development	2018
Introduction to Clinical Development Design (CDD) Framework	Emerging Trends and Technologies	2017 ACT Paper: Barriers and Solutions to Smart Clinical Program Designs	2017
Introduction to Clinical Development Design (CDD) Framework	Emerging Trends and Technologies	2016 PhUSE White Paper: Introduction to the Clinical Development Design (CDD) Framework	2016
Investigating Endpoint Modeling - Biomarkers ADA data and Immunophenotyping	NonClinical Topics	PhUSE Reference	2017
Linked Data & Graph Databases	Emerging Trends & Technologies	Reformed within ET&T	2017
Metadata Management	Emerging Trends & Technologies	White Paper	2014
Nonclinical Standardization Roadmap Team	Nonclinical Topics	The Roadmap for Nonclinical Data Standards and Elements to Improve Data Access	2013
Pooling WHO Drug B3 Format	Optimizing the Use of Data Standards	PhUSE White Paper	2018
Roadmap	Accomplishments	Nonclinical Standardization Roadmap Team
SEND Data for Analysis	Annotated examples	Application of SEND Data for Analysis
Standardizing data within the Inspection Site Selection Process	Optimizing the Use of Data Standards	PhUSE References	2016
Standards Implementation Issues with the CDISC Data Models	Optimizing the Use of Data Standards	White Paper	2013
Statistical Computing Environment	Emerging Trends & Technologies	PhUSE White Paper	2016
Study Data Standardization Plan (SDSP)	Optimizing the Use of Data Standards	Regulatory Referenced	2018
Test Submission Forum	See page for discussion	Test Submission Forum Group
Test Submission Forum Group	Nonclinical Topics	Poll & Wish List	2015

Concluded Projects

Metadata Management

• Metadata Definition Project: File:ET-project-template-metadata-definitions.doc
• Metadata Management Project: File:ET-project-Template - User Guide for E2E meta data management.doc

Statistical Computing Environments

Future Forum Interoperability & Technology

Introduction to Clinical Development Design (CDD) Framework
Clinical Trials Data as RDF