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This wiki is available to document the progress of the PHUSE Working Groups and Projects. The wiki enables quick, easy and transparent online collaboration. Working Groups each have a main page which is the starting page for all Working Group activity.

If you are new to wikis you might want to check out the help section. To get started click on your Working Group on the left hand side bar.

For instructions on how to subscribe to the Working Groups/Projects email

The Working Groups are governed by the Steering Committee which provides oversight to the Working Groups.

Working Groups & Projects Overview

With so many active projects within PHUSE, now is a great time to get involved. If you are interested in joining a project, please contact

Data Transparency Educating for the Future Emerging Trends & Technologies Nonclinical Topics Optimizing the Use of Data Standards Standard Analyses & Code Sharing
Clinical Trials Toolkit Data Engineering Blockchain SEND Datasets Best Practices for Data Collection Analyses & Displays White Papers
De-identification Standards Design Thinking Cloud Adoption Demystifying Define-XML Code Sharing (Repository)
GDPR Impact Data Science FHIR DRG in XML R-Shiny Interactive Forest Plot
Policy, Guidance & Materials Script Assessment Clinical Integrated Study Data and Analysis Data Reviewer's Guide Test Data Factory
EMEA Policy 0070 Nonclinical SDRG Good Programming Practice
Data De-identification Toolkit Data Visualisation SEND Implementation Data Standards for Non-Interventional Studies
Safety Signal Detection CDISC Implementation Primer
Open Source Technologies in Clinical Research SEND Progress Survey SDTM Implementation FAQ
Real World Evidence SEND Dataset QC Best Practices Submitting Study Data to Regulatory Authorities

Useful Information for Projects

Topic Overview Useful Links
NEW: Welcome Pack Want a detailed overview of our Working Groups and Projects? Want to know how to get involved? Hints and Tips for using Teamwork and the Wiki? Then this Welcome Pack is the place to go. It provides useful information for new projects and the on boarding of new project members. What support the PHUSE office provides as well as some useful links to help the projects progress Link
Working Groups Charter Defining the operating guidelines for PHUSE Working Group members Charter
Teamwork Teamwork is the collaboration tool used for our Projects and is available to project members. Once you have joined a project, you'll be granted access and once you've set up your account, you can then review the materials the projects produce Teamwork
Process Map PHUSE Standard Operating Procedure for Version Control of PHUSE Deliverables. Each project will produce a deliverable in some form, this flow chart and process will assist you in seeking approval for public review and ultimately finalisation. If you have any queries, please reach out to your Working Group Lead or
flow diagram
Working Practices Step by Step guide Working Practice Procedure
New Project Requests Do you have an idea for a PHUSE Project? Then complete this New Project Request Template and send to New Project Request
Giving a PHUSE Project presentation Working Groups Powerpoint Presentation Template Link
Giving a PHUSE Presentation Presenting at one of our conferences? This is the standard PHUSE Powerpoint Template Link
White Papers Template Is your project deliverable a White Paper? PHUSE has produced a White Paper Template to assist in the creation

Please refer to the Best Practices Guide for White Papers when completing your deliverable to ensure the guidelines are being adhered to. Link to White Paper template.

PHUSE Deliverables All of the final PHUSE projects deliverables can be found on the PHUSE Website CS Catalog of Deliverables on
Creating a Wiki Page The link will send you to a template for creating a new Wiki page. You can highlight the content and paste into your new page Link
Want to volunteer? We have new projects that are looking for volunteers. If you would like to join one of these projects, please contact Call for Volunteers
Webinar Wednesday To view the agenda and register for the upcoming Webinar Wednesday visit the PHUSE Website Webinar Wednesday Registration
Key Conference Dates Planning a deliverable for one of the PHUSE conferences? Want to know when registration closes? Visit the PHUSE website Conferences


FDA comments are an informal communication and represent the individual's best judgment. These comments do not bind or obligate FDA. The contents of this wiki are from the individual contributors and do not necessarily reflect the view and/or policies of the Food and Drug Administration, the employers of the individuals involved or any of their staff.