Final White Papers produced by the PhUSE Working Groups and Projects

Working Group White Paper Title Version and ID
Data Transparency 

Retrospective vs. Proactive Anonymization of Narratives

Clinical Trials Data Transparency Toolkit 

White Paper: A Global View

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

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Version 1.0 14-Mar-2019 :WP-018




Version 1.0: 11-Dec-2018 Doc ID: WP-014


Educating for the Future Data Processes in Other Industries Version 1.0: 04-Sept-2018 Doc ID: WP-010
  Clinical Trials Data as RDF Version 1:0 03-Jan-19
Emerging Trends & Technologies How Blockchain Can Transform the Pharmaceutical and Healthcare Industries Version 1.0: 17-Apr-18 Doc ID: WP-005
Alternative Transport: Transport for the Next Generation Version 1.1: 20-May-17
State of SCE Version 1.0: 29-Apr-16
Cloud Services: A framework for Adoption in the Regulated Life Sciences Industry Version 3.0: 18-Nov-16
Clinical Development Design Framework: An Information Model to Capture Decision-making for the Medical Product Life Cycle Version 1.0 27-Sept-17
Introduction of Clinical Development Design (CDD) Version 1:0: 01-Nov-16:
Metadata Definitions Document Definitions and examples relating to metadata and master data management.   Version 1.0: 15-Jul-14:
Nonclinical Topics

Investigating Endpoint Modeling: Nonclinical Biomarker Modeling

Application of SEND Data for Analysis 

Version 1:0: 03-Jan-17

Version 0.1: April-15

  Best Practices for Documenting Dataset Metadata: Define-XML Versus Reviewer’s Guide Version 1.0: 04-Apr-19 
Optimizing the Use of Data Standards Pooling WHOB3 Format Version 1.0: 20-Jun-18: Doc-ID: WP-004
Best Practices for Data Standards Implementation, Assigning Visitnum to Unplanned Visits & Assigning EPOCH to Observations Version 1.0: 06-Mar-14:
Study Level Traceability in a Non Linear Data Flow Version 1:0: 01-Oct-14
Traceability: Best Practices for Basic Linear Data Flow Version 1.0: 01-Oct-14
White Paper: Study Traceability in a Non Linear Data Flow Version 1.0: 01-Oct-14
Traceability: Current State Analysis Version 1.0: 21-Aug-13
Preliminary Recommendations for Traceability Documentation Using Define-XML 2.0 Version 1.0: 15-Dec-13
Standard Analyses & Code Sharing Script Metadata for Sharing  Version 1.0 03-Jan-19
Analyses & Displays Associated with Demographics, Disposition, & Medications in Phase 2-4 Clinical Trials & Integrated Summary Documents (PDF) Version 2.0: 02-Mar-18: Doc ID: WP003. Word Version.
Analysis & Displays associated with Adverse Events: Focus on Adverse Events in Phase 2-4 Clinical Trials & Integrated Summary Documents (PDF) Version 1.0: 03-Feb-17. Word  Version
Screen Shots of the Display created using Scripts contributed by the FDA (PDF) Version 1.1: 23-May-17. Word Version
Analyses & Displays associated with Thorough QT/QTc Studies (PDF) Version 1.0: 11-Mar-16. Word Version
Analyses & Displays Associated with Outliers or Shifts from Normal to Abnormal: Focus on Vital Signs, Electrocardiogram, & Laboratory Analyte Measurements in Phase 2-4 Clinical Trials & Integrated Summary Documents (PDF) Version 1.0: 10-Sept-15. Word Version
Analyses & Displays Associated to Non-Compartmental Pharmacokinetics - with a focus on Clinical Trials Version (PDF) Version 1.0: 25-Mar-14.
Analyses & Displays Associated with Measures of Central Tendency - Focus on Vital Sign, Electrocardiogram, & Laboratory Analyte Measurements in Phase 2-4 Clinical Trials & Integrated Submission Documents (PDF) Version 1.0: 10-Oct-13. Word Version

Standard Analyses White Papers

The Analysis and Display White Papers project team has authored multiple White Papers that provide advice on displaying, summarizing, and analyzing various types of data, common across therapeutic areas. The development of standard tables, figures, and listings will lead to improved and harmonized product lifecycle 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. Below is a list of final White Papers and additional White Papers and educational videos are in the pipeline.


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