Final White Paper Deliverables & References from Working Groups Projects

Special Projects

 White Papers & References


PHUSE Clinical Data Scientists Guide to Studies in COVID-19: Version 1.0, 16-Sep-2020

PHUSE Clinical Data Scientists Guide to Studies Impacted by COVID-19: Version 1.0, 07-Aug-2020

The Impacts of COVID-19 on Clinical Trial Transparency and Document Disclosure - PHUSE CTT Project - 06-May-2020

PHUSE Executive Pharma and CRO Summits 

 End-to-End Data Flow Today: Current Processes and Challenges: Version 1.0, 11-Feb-2020

 Data Transparency

White Papers & References

Working Group Leads:

Jean-Marc Ferran


Data Anonymisation and Risk Assessment Automation: Version 1.0, 01-Jul-2020 

PHUSE Data Transparency: A Global View of the Clinical Transparency Landscape—Best Practices Guide: Version 1.0, 12-Jun-2020

Clinical Trials Data Transparency Toolkit: Clinical Trial Transparency & Disclosure - A Global View: Version 2.0, 12-Jun-2020

Supporting Documents: CTT Country-level WorksheetGlobal View of Clinical Trial Transparency and Disclosure Events for a Single Study and Product Submissions 

If you wish to provide feedback on the paper or poster, please complete the feedback form

PHUSE Data Transparency Working Group - Recommendations for GDPR Compliancy:Version 1.0, 1-Apr-2020

The Impacts of COVID-19 on Clinical Trial Transparency and Document Disclosure - PHUSE CTT Project - 06-May-2020

PHUSE Data Transparency Group’s Response to NOT-LM-20-003: Request for Information (RFI): Modernization-11-Mar-2020

PHUSE re-start of EMA Policy 0070 Suggestions_20200117.pdf – “PHUSE Data Transparency Working Group’s Suggestions to EMA Policy 0070 Re-start – 17-January-2020” 

PHUSE DT WG - FDA Pilot Review Comments - v1.0.pdf: “PHUSE Data Transparency Working Group’s Comments on FDA’s Clinical Data Summary Report Pilot Program - Federal Register / Vol. 84, No. 124 of Thursday, June 27, 2019”

Protection of Personal Data in Clinical Documents - A Model Approach: Version 1.0, 10-Jun-2019

De-identification and Anonymization of Individual Patient Data in Clinical Studies - A Model Approach: Version 1.0, 10-Jun-2019

Policy 0070 Interpretations: Retrospective vs. Proactive Anonymization of Narratives: Version 1.0, 10-Jun-2019

De-identification Standards 

De-identification Standard for SDTM 3.2: Version 1.0, 15-May-2015


Comments on Canada’s Gazette, Part 1 of 9: December 2017

Comments on Health Canada’s Draft Guidance for the Implementation of the Public Release of Clinical Information: 10-Apr-2018

Educating for the Future

White Papers & References

Working Group Leads:

Ian Fleming

James McDermott

Data Processes in Other Industries: Review of Other Industry Processes: Version 1.0, 04-Sept-2018

Clinical Data Scientist Job Description: April 2018  

Emerging Trends & Technologies

White Papers & References


Working Group Leads:

Andy Richardson

Dhananjay (DJ) Chhatre

KPIs & Metrics Report - Year 2: Version 1.0, 28-Sep-2020

Basic Considerations for the Use of Real World Evidence (RWE) in Support of Regulated Clinical Trial Submissions: Version 1.0, 16-Jul-2020 

Data Visualisation Subject Level Data Review Summary Report: Version 1.0, 24-Jan-2020

Supporting Survey Results

Cloud Adoption – Framework Documents: Version 4.0, 24-Apr-2019 

KPI Metrics Report - Year 1: Version 1.0, Feb-2019 

Clinical Trials Data as RDF: Version 1.0, 03-Jan-2019

Use of HL7 FHIR as eSource to Pre-populate CDASH Case Report Forms Using a CDISC ODM API: 03-Jun-2018

How Blockchain Can Transform the Pharmaceutical and Healthcare Industries: Version 1.0, 17-Apr-2018

CDISC Foundational Standards in RDF Final: 20-Aug-2015

Metadata Management: Metadata Definitions Document: Version 1.0, 06-Jun-2016


Nonclinical Topics

White Papers & References


Working Group Leads:

Sue DeHaven

Patty Brundage

Recommendations for Anti-Drug Antibody (ADA) Modeling in SENDIG v3.0 and v3.1: 29-Feb-2020

Define-XML Codelist Recommendations: 27-Mar-2019

Data Consistency: SEND Datasets and Study Report

Handling of SEND in Study Documentation 

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

Community Opinions on the Collection and Use of Historical Control Data in Nonclinical Toxicity Studies: 22-Jul-2015

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

Optimizing the Use of Data Standards

White Papers & References


Working Group Leads:

Jane Lozano

Janet Low

Integration Strategies in Support of ISS/ISE Submissions: Version 1.0, 27-Oct-2020

CDISC Implementation Primer: Version 1.0, 12-Oct-2020

Data Standards for Non-interventional Studies: Version 1.0, 24-Sep-2020 

Industry Experiences Submitting Standardised Study Data to Regulatory Authorities: Version 1.0, 22-Sep-2020

Best Practices for Submissions of Event Adjudication Data: Version 1.0, 02-Dec-2019

DRG-XML Prototype Package Release: Version 2.0, 26-Nov-2019

Define-XML Version 2.0 Completion Guidelines: Version 1.0, 11-Jun-2019

Best Practices for Documenting Dataset Metadata: Define-XML Versus Reviewers Guide: Version 1.0, 04-Apr-2019

Pooled Submissions with WHODrug B3 Format Data: Version 1.0, 20-Jun-2018

Define-XML v2.0 Stylesheet Recommendations: 07-Dec-2018

Data Sizing Best Practices Recommendation 

Standardizing Data within the Inspection Site Selection Process Final Version: 26-May-2016

Summary of Traceability References

Safety Analytics

White Papers & References

Working Group Leads:

Mary Nilsson

Greg Ball

Please also see the Standard Analyses and Code Sharing section for Safety Related work prior to July 2020.

Planning and Interpreting Safety Analyses for Integrated Summaries Workshop: 21-Sep-2020

Adverse Event Collection and Treatment Emergence: Version 1.0 27-Aug-2020 

Standard Analyses & Code Sharing

White Papers & References


Working Group Leads:

Hanming Tu

Mary Nilsson

General Output Tips and Considerations: Version 1.0, 10-Aug-2020

Best Practices for Quality Control and Validation:Version 1.0, 22-Apr-2020

An R Shiny tool to create simplified TS Domain: 03-Oct-2019

Safety Analytics Workshop: CSS June 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

Script Metadata Recommendation for Sharing: Version 1.0, 03-Jan-2019

Analyses & Displays Associated with Demographics, Disposition, and Medications in Phase 2-4 Clinical Trials and Integrated Summary Documents: (PDF) Version 2.0, 02-Mar-2018. Word Version

Analysis & Displays Associated with Adverse Events: Focus on Adverse Events in Phase 2-4 Clinical Trials and Integrated Summary Documents: (PDF) Version 1.0, 03-Feb-2017. Word Version

Screen Shots of the Displays Created Using Scripts Contributed by the FDA: (PDF) Version 1.1, 23-May-2017. Word Version

Analyses and Displays Associated with Outliers or Shifts from Normal to Abnormal: Focus on Vital Signs, Electrocardiogram, & Laboratory Analyte Measurements in Phase 2-4 Clinical Trials and Integrated Summary Documents: (PDF) Version 1.0, 10-Sept-2015. Word Version

Analyses and Displays Associated with Measures of Central Tendency - Focus on Vital Sign, Electrocardiogram, and Laboratory Analyte Measurements in Phase 2-4 Clinical Trials and Integrated Submission Documents: (PDF) Version 1.0, 10-Oct-2013. Word Version

Script Metadata for Sharing: 27-Apr-2018

Test Dataset Factory: TDF_ADaM: ADaMIG v1.1 Test Datasets ADaM zip file: 07-Dec-2018

Test Dataset Factory: TDF_SDTM: SDTMIG v3.2 Test Datasets SDTM zip file: 07-Dec-2018

Topics in Pooling Data from Multiple Studies: 02-Nov-2017



Standard Analyses White Papers

The Analysis and Display White Papers project team has authored multiple white papers that provide advice on displaying, summarising, and analysing various types of data, common across therapeutic areas. The development of standard tables, figures and listings will lead to improved and harmonised product life cycle management across therapeutic areas by ensuring that reviewers receive clinically relevant and meaningful analyses of patient safety for benefit–risk assessment. While the white papers reflect recommendations that would lead to more consistent displays and analyses, the recommendations should not be interpreted as 'required' by any regulatory agency. Another purpose of the white papers is to improve expertise in safety analytics across the multiple disciplines involved with planning, interpreting, and reporting safety analyses. Educational videos are being created to facilitate the educational goals. Click here for a list of final and additional white papers. Educational videos are in the pipeline.


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