PhUSE Archived Projects

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Project Title (Alphabetical) 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 Data Collection Instructions This project, in collaboration with CDISC, will provide new CDISC implementers a primer to assist in the creation of standardized data to regulatory authorities. The project will identify needs of new implementers with an additional focus on academia and technology providers. The deliverable format (e.g. Wiki, white paper, slide deck, quickstart guides, etc.) will be made freely available to the public. White Paper 2020
Best Practices for Metadata Documentation: Define XML vs Reviewers Guide Optimizing the use of Data Standards White Paper 2019
Best Practices for Quality Control & Validation Standard Analyses & Code Sharing White Paper 2020
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
CDISC Implementation Primer This project, in collaboration with CDISC, will provide new CDISC implementers a guide to providing study data in standardized format to regulatory authorities. There will be an additional focus on academia and technology providers. The deliverable is a "CDISC Primer" (e.g. Wiki, white paper, slide deck, quickstart guides, etc.) will be developed to address this need and will be made freely available to the public. Primer 2020
Clinical Endpoint predictivity Activities completed NICE: Nonclinical data Interconnectivity for Clinical Endpoint predictivity
Clinical Legacy Plan & Reporting Optimizing the Use of Data Standards Regulatory Deliverables 2019
'''Clinical Trials Data as RDF Emerging Trends & Technologies PhUSE White Paper 2019
Communications, Promotion & Education Standard Analyses & Code Sharing Supported in publication of Working Group deliverables 2020
Data Consistency: Study Reports and SEND Datasets Nonclinical Topics SEND Implementation Wiki Guide 2020
Data Standards for Non-Interventional Studies This project addresses the challenges that programmers face during creation of the analysis datasets and handling of the data for the observational studies. The deliverable is a white paper documenting the challenges and possible solutions. White Paper 2020
Data Visualisations for Clinical Data Emerging Trends and Technologies N/A 2020
Completion Guidelines Optimizing the Use of Data Standards White Paper June 2019
'''Data Validation and Quality Assessment Optimizing the Use of Data Standards Validation Rules 2013
Demystifying Define-XML Codelists for Nonclinical Studies Nonclinical Topics SEND Define FAQ 2020
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
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities This project provides a collaborative, non-competitive forum for industry to share submission experiences including, but not limited to submission planning, interactions with the regulators, test submissions, regulator feedback etc. Additionally, this project will explore the development of best practices for biometrics departments to engage with regulators. The project will examine different communication use cases and make recommendations as to ensure effective exchange of information. White Paper 2020
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 Nonclinical Topics White Paper 2020
Investigating Endpoint Modeling - Biomarkers ADA data and Immunophenotyping NonClinical Topics PhUSE Reference 2017
Key Performance Indicators & Metrics Emerging Trends and Technologies Report (September 2020) 2020
Linked Data & Graph Databases Emerging Trends & Technologies Reformed within ET&T 2017
'''Machine Learning & Artificial Intelligence Emerging Trends and Technologies 2020
'''Metadata Management Emerging Trends & Technologies White Paper 2014
Modelling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies Nonclinical Topics White Paper 2020
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
Stylesheet Recommendations Optimizing the Use of Data Standards Recommendations March 2019
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

Statistical Computing Environments
Future Forum Interoperability & Technology
Introduction to Clinical Development Design (CDD) Framework
Clinical Trials Data as RDF
Data Visualisation as an Enabler for Nonclinical Safety Signal Detection
Use of Data Visualisation for Subject Level Data Review