PhUSE Working Group References

Working Group References Produced   
Data Transparency 

PhUSE Data Transparency Working Group’s Comments on Canada’s Gazette, Part 1 of 9.: December 2017

PhUSE Data Transparency Working Group’s Comments on Health Canada’s Draft Guidance for the Implementation of the Public Release of Clinical Information of 10 April 2018.

Educating for the Future Clinical Data Scientist Job Description : Published April 2018:    
Emerging Trends & Technologies

CDISC Foundational Standards in RDF Final Version: 30-AUG-15: CDISC has officially taken this on


Use of HL7 FHIR as eSource to Pre-populate CDASH Case Report Forms using a CDISC ODM API 

 Develops and demonstrates the use of new extensions to the CDISC ODM and CDASH standards metadata to enable information systems to retrieve and apply FHIR resource content to serve a variety of eSource and RWE use cases. 





Nonclinical Topics

Define-XML Codelist Recommendations: 27-03-19: The Demystifying Define-XML project have provided recommendations for specific problems/questions encountered, when fulfilling the define.xml codelist section for nonclinical studies. 

Investigating Endpoint Modeling Biomarkers, ADA Data & Immunophenotyping  Version 1.0: 03-Jan-17: The Investigating Endpoint Modeling PhUSE project team embarked on an investigation in 2015-2016, to determine suitable ways to model endpoints, which are not modelled in the SEND Implementation Guide (SENDIG V 3.0) and develop a methodology for the inclusion of data such as biomarker, anti-drug antibody (ADA) and immunophenotyping results. This paper describes recommendations for a methodology to include data such as biomarkers into a SEND dataset and the decision making process utilised. The paper presents possible best practices for inclusion of unmodeled endpoints with a consistent methodology.


Journal Article : Graphical display of histopathology data from toxicology studies for drug discovery and development: An Industry Perspective: Histopathology data comprise a critical component of toxicology studies and are typically presented as organ-specific incidence counts, tabulated in study reports. Various software applications are available to convert histopathology data into graphical displays for visual presentation. This article was published in the Journal: Regulatory Toxicology & Pharmacology, Volume 82, December 2016, Pages 167-172


Visualisation of Group Related Differences in Histopathology Data: Deliverables from the project team included 3 posters presented at FDA PhUSE CSS meetings and one publication. It is the project team's intent to place HistoGraphic on a publicly assessed site for downloading.

Data Consistency: SEND Datasets and Study Report: The Data Consistency: SEND Datasets and the Study Report Working Group formed at PhUSE CSS 2016 and was tasked with identifying and addressing potential inconsistencies between the study report and SEND v3.0 datasets. Team members identified scenarios which could lead to inherent differences between SEND datasets and study reports. The team created a listing of potential inconsistencies identified and associated recommendations, which are provided in this paper.


Journal Article: Interconnectivity of Disparate Nonclinical Data Silos for Drug Discovery and Development 22-Apr-14: Pharmaceutical research and development generates enormous amounts of nonclinical and clinical data related to safety and efficacy and the ability to manage and utilze these data is critical for discovering and developing new drugs. Information systems exist that store and analyze relationships among seemingly disparate data sets (i.e, data silos); however, to fully utilize the potential of these informatics systems, it is necessary to define basic parameters about the data and to develop concepts regarding 'interconnectivity' or relationships among disparate data sets. This article was published in the Therapeutic Innovation & Regulatory Science, DIA Scientific Journal, 2014.

Roadmap for Nonclinical Data Standards and Elements to Improve Data Access: Identifies points to consider when implementing Nonclinical Standards, sets priorities for Nonclinical data types and considerations for future Nonclinical Standards development. 

SEND Implementation Wiki: Knowledge base for SEND implementers including reference articles, links, modelling basics and FAQ's.

The Handling of SEND References in Study Documentation: Recommendations for handling references to SEND in study documentation (e.g. Protocol, Contracts, etc)

Optimizing the Use of Data Standards

Define XML 2.0 Stylesheet Recommendations - 07-Dec-18

Best Practices for Data Sizing: Provides recommendations managing the length of character variables in a submission, handling SAS transport files that exceed the maximum allowable size and documenting split domains in Define-XML


Standardizing Data within the Inspection Site Selection Process Final Version: 26-MAY-16: "Guidance for Industry: Providing submissions in electronic format.

Traceability References: Summarises and interprets traceability references found in the public domain (e.g. Conference Papers, CDER Common Data Standards issue document etc)

Standard Analyses & Code Sharing

Script Metadata for Sharing: Hanming Tu, Frontage 


Test Data Factory: TDF_ADaM: ADaMIG v1.1 Test Datasets, 07-Dec-18. ADaM Zip File 


Topics for Pooling Data from multiple studies: Brenda Crowe, Lilly 


Test Data Factory: TDF_SDTM: SDTMIG v3.2 Test Datasets, 07-Dec-18. SDTM Zip File 



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