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Welcome to the PHUSE Wiki

The PHUSE Wiki is an PHUSE/FDA/Industry collaboration to provide a medium to share information specifically relating to clinical trial informatics.

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Currently 6,861 users are helping to Connect, Share, Advance clinical informatics.

All content on this wiki is non-binding. All content expresses opinions of users and not necessarily that of their employer nor PHUSE. See our Disclaimers page

Need help with the Wiki? Ideas to Improve?

The Wiki Team are always looking at ways to improve this site. We want to make this user friendly, current and of benefit to PHUSE Members. If you have a question, query or need help, please use this 'Discussion Forum'. A member of the team will do their best to assist and all feedback is welcome. Equally should you wish to be part of the team, contact

PHUSE Events

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Click here to listen back and view the presentations

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Gone Virtual. Check website for updates

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Registration now open.

Become a PHUSE Member

There are many benefits to becoming a PHUSE member. Here's just a few reasons why you want to become part of something amazing

  • Free attendance to a range of Single Day Events held across US, EU and Asia
  • Access to PHUSE Blog
  • Full access to PHUSE Archives
  • Participation in our annual US & EU Connects and the US Computational Science Symposium

To become a member, sign up here

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Working Groups News

Working Groups Summer Blog
The Working Groups Summer Blog is now live! We’ve plenty of new and exciting updates to share, click here to read. 

Final Published Deliverables

Since non-interventional study data do not necessarily need to be submitted to a regulatory agency, such as the FDA, there is no strict requirement for data standards.The Data Standards for Non-interventional Studies project has developed a White Paper which looks to identify the most common data standards challenges programmers experience while working on non-interventional studies and to suggest the means to deal with these challenges. Click here to read the paper. 

The Optimising the Use of Data Standards – Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Project has published a White Paper. The paper aims to share submission experiences and develop best practices including submission strategy and planning, regulatory requirements, and interactions with the regulators.

PHUSE convened a group of experts from across industry to address the particular challenges Clinical Data Scientists may face in their work. This group has published a White Paper which offers perspectives from industry experts on what Clinical Data Scientists can expect in studies in COVID-19 and strategies to address some of the challenges they may encounter. This group has also published a series of blogs providing timely advice as well as an additional White Paper that considers the impacts of COVID-19 on the collection and analysis of clinical trial data.

The SDTM ADaM Implementation FAQ project has published responses to questions submitted on Data Submissions.

Deliverables out for Public Comment
PHUSE Working Groups Projects are soliciting feedback from the broader community on a wide range of deliverables. Click here to review the documents and provide your feedback.

Virtual Events
The PHUSE Japan Working Groups are hosting a Webinar on October 8th. The Webinar, which will be in Japanese will cover the following topics; 

  • PHUSE Updates - Japan Working Groups and Japan Single Day Event in December
  • Explore the Potential Value of Real-world Data by Using MDV Services
  • Next Generation Medical Infrastructure Act: Full Scale Operation to Create Evidence

Register here' October 8th 2020, 16:00 (JST) 8:00 (BST) 3:00 (EDT)

Industry News

GDPR has gone live. Please review PHUSE Privacy Policy

PHUSE Collaborations

Here's the link to the latest version of the Technical Conformance Guide (TCG) which was updated by the FDA March 2020

Last revision by Laurenwhite, 09/24/2020