PhUSE Working Groups Welcome Pack

1. PhUSE Working Groups Welcome Pack

2. 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 Index

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 workinggroups@phuse.eu 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 Beate Hientzsch Education Director Frank Senk Membership Director Sarvesh Singh APAC Director Stephen Bamford PhUSE Founder & Chairman of the Board Sascha Ahrweiler Communications Director John Salter EMEA Director Working Groups Directors Scott Bahlavooni & Chris Price Yvonne Moores Special Projects Director

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 • 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 Wendy Dobson • Project Assistant: • Supports the following Working Groups and Projects within: • Data Transparency • Emerging Trends and Technologies • Nonclinical Topics • Facilitates the PhUSE Wiki Team • Facilitates Webinar Wednesday Lauren White

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 Data Transparency Optimizing the Use of Data Standards Emerging Trends & Technologies Nonclinical Topics Educating for the Future Standard Analyses & Code Sharing Clinical Trials Toolkit De-identification Standards Data Collection Legacy Data Conversion Blockchain (5) Cloud Adoption SEND Datasets Demystifying Define-XML Data Engineering Design Thinking Analyses & Displays White Paper (5) Code Sharing (Repository) Data Science Data Standards Non-Interventional Studies GDPR Impact Policy, Guidance & Materials DRG in XML FHIR KPI Summary & Reporting ADA Endpoints Script Assessment Comms, Promo & Education Test Data Factory Going Translational with Linked Data Data Visualisation (3) EMA Policy 0070 Data De-identification Toolkit 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 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 Ian Fleming • Current Projects: • Data Engineering • Design Thinking • Data Science James McDermott

13. PhUSE Working Group & Projects 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 Andy Richardson • 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 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 Susan DeHaven • 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 Patricia Brundage

15. PhUSE Working Group & Projects 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 Hanming Tu • 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 Mary Nilsson

16. PhUSE Working Group & Projects • 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 Jean-Marc Ferran • 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 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 Jane Lozano • 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 Lisa Brooks

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 • Project Leads: • 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 Deliverables: 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 workinggroups@phuse.eu. 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 email at workinggroups@phuse.eu 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: https://www.phuse.eu • Wiki: https://www.phusewiki.org/wiki/index.php?title=PhUSE_Wiki • PhUSETube: https://www.youtube.com/user/PhUSETube • Facebook: https://www.facebook.com/phusebook/ • Instagram: https://Instagram.com/phusesnappa • Twitter: https://twitter.com/PhUSETwitta • LinkedIn: https://www.linkedin.com/company/phuse/ • PhUSE News: members only • Mailshots: members only • Webinars: open to anyone wishing to present • PhUSE Pin: https://in.pinterest.com/PhUSEpin/