PhUSE Working Groups References

Data Transparency

Educating for the Future

Emerging Trends & Technologies 

Comments on Canada’s Gazette, Part 1 of 9: December 2017 Clinical Data Scientist Job Description: April 2018   CDISC Foundational Standards in RDF Final: 20-Aug-2015. CDISC has officially taken this on
Comments on Health Canada’s Draft Guidance for the Implementation of the Public Release of Clinical Information: 10-Apr-2018   Use of HL7 FHIR as eSource to Pre-populate CDASH Case Report Forms Using a CDISC ODM API: 03-Jun-2018

 

Nonclinical Topics

Optimizing the Use of Data Standards

Standard Analyses & Code Sharing

Define-XML Codelist Recommendations: 27-Mar-2019 Define-XML v2.0 Stylesheet Recommendations: 07-Dec-2018 Script Metadata for Sharing: 27-Apr-2018
Data Consistency: SEND Datasets and Study Report Data Sizing Best Practices Recommendation Test Dataset Factory: TDF_ADaM: ADaMIG v1.1 Test Datasets, 07-Dec-2018. ADaM zip file 
Handling of SEND in Study Documentation Standardizing Data within the Inspection Site Selection Process Final Version: 26-May-2016 Test Dataset Factory: TDF_SDTM: SDTMIG v3.2 Test Datasets, 07-Dec-2018. SDTM zip file 
Investigating Endpoint Modeling Biomarkers, ADA Data & Immunophenotyping: Version 1.0: 03-Jan-2017 Summary of Traceability References Topics in Pooling Data from Multiple Studies: 02-Nov-2017
Journal Article: 

Graphical display of histopathology data from toxicology studies for drug discovery and development: An industry perspective

Volume 82, December 2016, pages 167–172.
 

Safety Analytics Workshop: CSS 2019

Slide Presentation:

Recording: Slides 1-19, Introduction & Background

Recording: Slides 20-49, Adverse Events

Recording: Slide 50, Adverse Events Q&A

Recording: Slides 51 - 66, Labs

Recording: Slides 68 - 72, Medications & Disposition

Recording: Slides 73 - 74, Summary

Recording: Slide 75, General Q&A

Journal Article: Interconnectivity of Disparate Nonclinical Data Silos for Drug Discovery and Development 22-Apr-2014    
Roadmap for Nonclinical Data Standards and Elements to Improve Data Access    
SEND Implementation Wiki: Knowledge base for SEND implementers    
Visualization of Group-related Differences in Histopathology Data    

 

 

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