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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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Pune, India March 28th

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Registration is still open

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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

NEW: Best Practices for writing PHUSE White Papers

The PHUSE Steering Committee have produced guidelines on how to write a White Paper. Suggestions from length of the paper and writing style, to how best to keep your audience engaged are all useful tips. You can find the Best Practices here.

In line with the Best Practices for writing White Papers, you will find the White Papers template here, together with plenty of other useful information to help support you and your project.

The Nonclinical Topics Working Group would be grateful if you could take a moment to assist in the annual data gathering by completing this short survey on industry SEND (Standard for Exchange of Nonclinical Data) readiness and implementation. 

The results of the teams recent efforts can help every organisation see where they are in relation to other organisations around the world that are striving to implement SEND solutions. Results will be published on the PHUSE Wiki and at the PHUSE Computational Science Symposium in June 2020. 

This survey will close March 13th 2020.

PHUSE Latest Deliverables:

The Data Visualisation project conducted an updated analysis of the current tools used to review subject level data, including the use of interactive visualisations for generating patient profiles and patient narratives. This paper focuses on three types of subject level data representations:Tabular Patient Profiles, Graphical Patient Profiles and Patient Narratives. Click here to view the White Paper. 

The Best Practice for Submission of Event Adjudication Data has released a White Paper mapping out the common practices and challenges for submissions of event adjudication data. Click here to download the paper.

The Data Reviewer's Guide in XML project from the Optimising the Use of Data Standards Working Group have released v2.0 of the Prototype Package. This prototype release v2.0 package looks to provide a more stable version for industry early adoption and testing for a future final publication that encompasses all DRGs. Click here to download the full package. 

Log in to your PHUSE account and visit the members blog to find a summary of all the latest news within the industry.

Industry News

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PHUSE Collaborations:


Here's the link to the latest version of the Technical Conformance Guide (TCG) which has been updated by the FDA October 2019

Last revision by Laurenwhite, 01/24/2020