1. PhUSE Working Groups
Welcome Pack

2. Index Welcome to PhUSE PhUSE Working Groups: Structure PhUSE BoD
PhUSE Working Groups BoD: Roles & Responsibilities
PhUSE Working Groups: Office Support
PhUSE Working Groups Office Support: Roles & Responsibilities
PhUSE Steering Committee
Vendor Neutrality
PhUSE Projects: Structure
Working Groups and Projects: Overview
Working Group Leads: Roles & Responsibilities
Project Leads and Members: Roles & Responsibilities
Processes: Deliverables & New Projects
PhUSE Tools
Training Guides: Teamwork
Training Guides: Wiki
Membership Benefits
PhUSE Social Platforms

3. Welcome to PhUSE
Thank you for contributing to one of our many active Projects within the PhUSE Working Groups. In this welcome pack, you’ll find information on our processes, together with guidelines and expectations for our Projects and members alike
In addition, there are training materials that will help guide you through some of the Project tools and processes we use
Finally, we’re here to help, so if you have any questions, please feel free to contact us at
On behalf of PhUSE, thank you for your dedication and commitment. We look forward to working with you

4. PhUSE Working Groups Structure

5. PhUSE BoD For detailed content on our Board members, follow this link
Adrienne Bonwick
Operations Director
John Hirst
Finance Director
Chris Hurley
Americas Director
Anup Patel
Technical Director
Frank Senk
Membership Director
Beate Hientzsch
Education Director
Stephen Bamford
PhUSE Founder &
Chairman of the Board
Sarvesh Singh
APAC
Director
Sascha Ahrweiler
Communications Director
Yvonne Moores
Special Projects Director
John Salter
EMEA
Working Groups Directors
Scott Bahlavooni &
Chris Price

6. PhUSE Working Groups BoD: Roles and Responsibilities
Remit:
Coordinate the Working Groups’ activities for PhUSE, ensuring deliverables progress the industry knowledge base
Form and maintain strategic and technical relationships with similar organizations (e.g. CDISC, HL7) so that deliverables are fully aligned across initiatives
Form and maintain relationships with regulatory agencies (e.g. the FDA, EMA and PMDA)
Liaise with the PhUSE Office and other relevant stakeholders to ensure effective communication of all deliverables for all PhUSE Working Groups
Enable/promote cross-sharing of ideas, resources and methods across all Working Groups
Establish operational processes incorporating collaboration from contributors within the decision-making and Project development processes
Work with the Communications Director, Steering Committee, Working Groups and Project Teams to provide outward bound information on the Working Groups’ activities
Appoint the Working Group Leads on the identification of a vacancy. For existing Working Groups, this should be following an open and transparent application process
Chris Price
Scott Bahlavooni

7. PhUSE Working Groups: Office Support
Wendy Dobson
Lauren White
Project Manager:
Supports the following Working Groups and Projects within:
Educating for the Future
Optimizing the Use of Data Standards
Standard Analyses & Code Sharing
Facilitates the PhUSE Steering Committee
Facilitates the PhUSE CSS Planning Committee
Project Assistant:
Data Transparency
Emerging Trends and Technologies
Nonclinical Topics
Facilitates the PhUSE Wiki Team
Facilitates Webinar Wednesday

8. PhUSE Working Groups Office Support: Roles & Responsibilities
Setting up Project calls, from seeking availability to sending out calendar invites
Generating agendas, initiating the call, capturing and publishing of minutes/actions
Setting up new Project members on the Wiki and Teamwork
Providing training and guidance on the use of the software tools available
Call for volunteers via our advertising channels
Seeking presenters and facilitating the monthly webinars
Publication of draft/final deliverables
Feeding Project progress upwards
Generating surveys
Editing of PhUSE Wiki and Teamwork
Highlighting cross-collaboration opportunities
Providing guidance on the deliverables and new Project request processes
Providing information on key dates such as event early bird, and Project deliverables
Supporting the production of presentations
Providing corporate templates for Project-related tasks
Versioning of controlled documents

9. PhUSE Steering Committee
All PhUSE Working Groups are overseen by the Steering Committee. The remit of the Steering Committee is to:
Facilitate discussions among regulatory agencies, industry and other stakeholders that inform and improve computational science to support product development and review
Bring together experts in specific areas to collaborate on computational science, describe best practices in challenging areas, and propose methods for addressing knowledge gaps
Support ongoing collaborative Working Groups and Project groups throughout the year by aligning Working Groups’ objectives, reviewing Project requests and deliverables, and providing direction for Project issues and gaps
Support an annual public conference where collaborators and interested individuals come together to summarize and share work accomplished to date and plan for future efforts
Establish an infrastructure and operational processes with the following components:
transparent processes that promote exchange of ideas
help gathering input from all primary stakeholders (e.g. regulatory agencies, industry, academics, standard development organizations (SDOs)
creating an open and efficient method for submitting potential Projects, providing an objective evaluation and approval process for proposed Projects
providing a framework for hand-off of deliverables between Project Teams and appropriate organizations using formal processes, as defined by the receiving organizations

10. Vendor Neutrality
Vendor neutrality is a business and design approach that seeks to ensure broad compatibility and interchangeability of products and technologies. The model encompasses standardization, non-proprietary design principles and unbiased business practices
At PhUSE, we will not favor one software, standard or programming language to the detriment of others, and we will always look to provide an impartial platform for all ideas to be shared, discussed and documented openly, transparently and factually

11. PhUSE Board of Directors
Steering Committee
Optimizing the Use of Data Standards
Data Transparency
Emerging Trends & Technologies
Nonclinical Topics
Educating for the Future
Standard Analyses & Code Sharing
Data Collection
Legacy Data Conversion
Clinical Trials Toolkit
De-identification Standards
Blockchain (5)
Cloud Adoption
SEND Datasets
Demystifying Define-XML
Data Engineering
Design Thinking
Analyses & Displays White Paper (5)
Code Sharing (Repository)
Data Science
DRG in XML
Data Standards Non-Interventional Studies
GDPR Impact
Policy, Guidance & Materials
FHIR
KPI Summary & Reporting
ADA Endpoints
Script Assessment
Comms, Promo & Education
Test Data Factory
EMA Policy 0070
Data De-identification Toolkit
Going Translational with Linked Data
Data Visualisation (3)
Nonclinical SDRG
SEND Implementation
Good Programming Practices (1)
Quality & Control Validation (4)
CDISC Implementation Primer (4)
SDTM Implementation FAQ (2)
ML / AI (4)
Safety Signal Detection
SEND Progress Survey
Submitting Study Data to Reg Authorities (3)
No: Denotes Sub-teams
(subject to change)
Correct as of February, 2019

12. PhUSE Working Group & Projects
Ian Fleming
James McDermott
Working Group Leads: Educating for the Future
Scope: The goal of this group is to develop frameworks by which to educate the PhUSE community at large. The frameworks will be designed to educate the community on the importance of topics where we feel there are gaps, the details of the topics themselves, and how they can be used to drive innovation within the industry
Current Projects:
Data Engineering
Design Thinking
Data Science

13. PhUSE Working Group & Projects
Andy Richardson
Working Group Lead: Emerging Trends & Technologies
Scope: This group is a forum for sharing pre-competitive means of applying new technologies and is challenged with the creation of well-defined collaborative Projects that will describe, prioritise, assess, and assist advancement of these opportunities. Possible topics include (but are not limited to) semantic web applications, analysis metadata, modeling, simulation, and “the Cloud”. Projects incorporating these topics might include prioritisation, development, and piloting for feasibility and value
Current Projects:
Blockchain Technology
Cloud Adoption In the Life Sciences Industry
Data Visualisations for Clinical Data
Going Translational with Linked Data
Investigating the Use of FHIR in Clinical Research
Key Performance Indicators & Metrics
Machine Learning/Artificial Intelligence

14. PhUSE Working Group & Projects
Susan DeHaven
Patricia Brundage
Working Group Leads: Nonclinical Topics
Scope: Our focus is on using informatics approaches and standards for delivering ideas and solutions to nonclinical data challenges. At the annual Computational Science Symposium (CSS), we present our progress and achievements to date, as well as develop new Projects that further the value of nonclinical data
Current Projects:
Data Consistency: SEND Datasets and the Clinical Study Report
Data Visualisation as an Enabler for Nonclinical Safety Signal Detection
Demystifying Define-XML: Codelist Handling for Nonclinical Studies
Industry SEND Progress Survey
Modeling ADA Endpoints
Nonclinical Script Assessment
Nonclinical Study Data Reviewer’s Guide (SDRG)
SEND Implementation User Group

15. PhUSE Working Group & Projects
Hanming Tu
Mary Nilsson
Working Group Leads: Standard Analyses & Code Sharing
Scope: Leverage crowdsourcing to improve the content and implementation of analyses for medical research, leading to better
data interpretations and increased efficiency in the clinical drug development and review processes
Current Projects:
Analysis & Display White Papers
Best Practices in Quality Control and Validation
Code Sharing (Repository)
Communication, Promotion and Education
Good Programming Practice in Macro Development
Test Data Factory

16. PhUSE Working Group & Projects
Jean-Marc
Ferran
Working Group Leads: Data Transparency
Scope: There are current efforts by regulators such as the EMA to make Clinical Study Reports (CSRs) and Individual Patient Data (IPD) from clinical trials shared more widely. Sponsors have been sharing IPD based on request proposals from researchers and because:
data in different data models is available
each company seems to be defining their own high-level guidelines for data de-identification
it is possible to request data from different companies within the same research proposal
Current Projects:
Clinical Trials Data Transparency Toolkit
GDPR Impact on Data Collection Practices
PhUSE De-identification Standards
Policy 0070 Interpretations
Policy, Guidance & Materials Review
Data De-identification Toolkit
Liz Roberts

17. PhUSE Working Group & Projects
Jane Lozano
Working Group Leads: Optimizing the Use of Data Standards
Scope: The development and adoption of data standards over the last decade has shown significant promise in improving efficient delivery of data to support drug product and device submissions as well as the review process. However, there have also been gaps, issues and challenges in the interpretation and use of data standards. This group works to identify specific gaps that prevent the FDA and industry from optimizing the use of data standards
Lisa Brooks
Current Projects:
Best Practices for Data Collection and Instructions
CDISC Implementation Primer
Clinical Legacy Data Conversion Plan and Report
Data Reviewer’s Guide in XML
Data Standards for Non-Interventional Studies
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities
SDTM/ADaM Implementation FAQ

18. Working Group Leads: Roles & Responsibilities
Responsible for Projects within their WG, working to ensure the success of each Project
Provide a single point of contact for Project Teams, and manage communications to and from the Steering Committee
Propose new Projects to the Steering Committee
Assure a well-defined, manageable Project scope, capable of being accomplished within a predetermined time frame
Assure goals of the Project are attainable through a partnership within the context of the WG
Assure the Project will have at least two Co-Leads and sufficient participating members to ensure success
Provide an avenue of communication between the Steering Committee and the Project Leads to allow all Project Teams to be informed of Project-related information in a timely and appropriate manner
Work with Project Leads to understand any Project issues that may affect the success of the Project and raise those issues to the Steering Committee for further discussion if needed
Bring all Project deliverables to the attention of the Steering Committee for approval prior to deliverables being published in the public domain

19. Project Leads & Members: Roles & Responsibilities
Responsible for the overall success of the Project and for delivering Project results within agreed proposed timelines
Manage all Project Team activities:
Manage meetings
Set expectations for the team
Manage Project tasks
Provide adequate communication
Ensure Project Team deliverables are provided in a timely manner:
Create well-reviewed and vetted deliverables
Ensure cross-functional input and subject matter expertise
Provide strategy for overcoming obstacles
Project Members:
Actively contribute and participate in Project calls
Deliver on commitments to timelines
Communicate effectively by providing high-level updates if absent from team calls

20. Processes: Deliverables & New Projects
Each Project’s output will be a deliverable in some format, be it a White Paper, poster or reference
To assist the Projects in the flow of their deliverable, the PhUSE Steering Committee have produced a process and flowchart. This provides you with a step-by-step guide about the review process and, ultimately, the final publication of your deliverable
Link to flowchart
Link to Working Practice
Link to PhUSE final published deliverables
New Projects:
If you have an idea for a new PhUSE Project, follow this link to find the New Project Request Template. Please complete and send to PhUSE office can support the call for volunteers

21. PhUSE Tools
To assist in the development and collaboration of a Project, there are a number of tools and platforms available to Project members:
Teamwork (Project members only)
PhUSE Wiki (public forum)
PhUSE Webinars – promote your Project, updates from other Projects
GoToMeeting/JoinMe – dial in details available for your meetings
Doodles/WhenisGood – seeking availability for team members
Working Group Templates for White Papers, Presentations
Survey Monkey – Software tool to produce surveys for projects when requiring industry feedback

22. PhUSE Training Guides

23. Training Guides: Teamwork Notebook

24. Training Guides: Teamwork Files

25. Training Guides: Teamwork Files

26. Training Guides: Teamwork Files

27. Training Guides: Wiki
Here are some useful links to assist you with the PhUSE Wiki
The Wiki Project Support Team can assist with any queries you may have, and are keen to welcome new members to the group. If you are interested in joining or wish to ask the Team a question, please contact us by at
The Team welcome feedback on the layout, content and general look of the Wiki and have set up a discussion forum. If you have any thoughts or suggestions, then feel free to post them here
Setting Up of a Wiki Account link
Basic Editing & How-to Videos link
Training Presentation link
Useful Information such as Templates link

28. Membership Benefits
Participating in a PhUSE Project doesn’t mean you have to be a PhUSE member. However, there are many benefits that can be gained in being part of the largest not-for-profit biometrics society:
free attendance at a range of themed Single Day Events (SDEs) across the globe
participation in our annual US & EU Connect conferences and the US Computational Science Symposium (CSS)
access to PhUSE News, the official quarterly newsletter, and the PhUSE Monthly Mailing, which provides regular industry news and updates
full access to PhUSE Archives including keynote speaker videos, papers and presentations from past events

29. PhUSE Social Platforms
Website:
Wiki:
PhUSETube:
Facebook:
Instagram:
Twitter:
LinkedIn:
PhUSE News: members only
Mailshots: members only
Webinars: open to anyone wishing to present
PhUSE Pin: