Final White Papers Produced by the PhUSE Working Groups and Projects

Working Group White Paper Title Version and ID
Data Transparency
 
 

 

Protection of Personal Data in Clinical Documents - A Model Approach

 

De-identification and Anonymization of Individual Patient Data in Clinical Studies - A Model Approach

Policy 0070 Interpretations 

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 

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

 

De-identification Standards 

De-identification Standard for SDTM 3.2

Appendices 

 

Version 1.0 10-Jun-2019 :WP-27

 

Version 1.0 10-Jun-2019 :WP-28

 

Version 1.0 14-Mar-2019 :WP-018

 

 

 

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

 

 

 

Version 1.0.1: 15-May-2015

 

Version 1.0: 15-May-2015

Version 2.0: 19-May-2017

Educating for the Future
Data Processes in Other Industries: Review of Other Industry Processes Version 1.0: 04-Sept-2018 Doc ID: WP-010
 

Cloud Adoption – Framework Documents

Version 4:0 24-Apr-19 
  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 the SCE Version 1.0: 29-Apr-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 to the Clinical Development Design (CDD) Framework Version 1:0: 01-Nov-16:
Metadata Management: 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

Version 1:0: 03-Jan-17

 

  Define-XML Version 2.0 Completion Guidelines

Version 1.0: 11-Jun-19

WP-015

  Best Practices for Documenting Dataset Metadata: Define-XML Versus Reviewer’s Guide Version 1.0: 04-Apr-19 
Optimizing the Use of Data Standards
Pooled Submissions with WHODrug B3 Format Data Version 1.0: 20-Jun-18: Doc-ID: WP-004
Best Practices for Data Standards Implementation: Assigning VISITNUM to Unplanned Visits and Assigning EPOCH to Observations Version 1.0: 06-Mar-14:
Study Level Traceability Considerations: Best Practices for Non-Linear Data Flow Version 1:0: 01-Oct-14
Traceability and Data Flow: 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 and Data Flow: Current State Analysis Version 1.0: 21-Aug-13
Preliminary Recommendations for Traceability Documentation Using Define-XML v2.0 Version 1.0: 15-Dec-13
Standard Analyses & Code Sharing
Script Metadata Recommendation for Sharing  Version 1.0 03-Jan-19
Analyses & Displays Associated with Demographics, Disposition, and Medications in Phase 2-4 Clinical Trials and 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 and Integrated Summary Documents (PDF) Version 1.0: 03-Feb-17. Word  Version
Screen Shots of the Displays Created Using Scripts Contributed by the FDA (PDF) Version 1.1: 23-May-17. Word Version
Analyses and Displays Associated with Thorough QT/QTc Studies (PDF) Version 1.0: 11-Mar-16. 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-15. Word Version
Analyses and Displays Associated to Non-Compartmental Pharmacokinetics - with a Focus on Clinical Trials (PDF) Version 1.0: 25-Mar-14.
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-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, 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.

 

Thinking of joining PhUSE?

Already a member but not sure how you can benefit?

PhUSE is an expanding, global society with a membership of more than 9,000 clinical data scientists. It requires a large pool of resources to help with its running, and so there are many opportunities for members to become involved. Whether it's chairing a conference, presenting at an event, leading a working group or contributing to the quarterly online newsletter, we are always keen to hear from volunteers.

Find Out More