PhUSE Wiki

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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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Join a Working Group now!

Currently 6,798 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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Registration is open

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April Events: Heidelburg, Germany - Foster City, California

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Call for Papers closes 26th April: Registration is open

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Registration & Call for Papers opens 1st July

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 News
  • 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

Create a new Wiki page

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Working Group News

New The Demystifying Define-XML Codelist for Nonclinical Studies project has provided recommendations for specific problems/questions encountered, when fulfilling the define.xml codelist section for nonclinical studies. To view the projects recommendations visit the SEND Implementation Wiki page.

New: Data Standards for Non-Interventional Studies project would like to reach out to you again and ask you for your input. We are now trying to get an overview of the challenges you have faced from the perspective of implementation of CDISC standards for non-interventional studies. If you have tried to implement ADaM and/or SDTM for non-interventional studies, please take a few minutes to complete this very short survey. Your feedback is very much appreciated! This survey closes 26th April.

New The PhUSE Optimizing the Use of Data Standards Working Group has published a White Paper on Best Practices for Documenting Dataset Metadata: Define-XML Versus Reviewer’s Guide. Click here to view the paper.

If you are interested in contributing to one of our projects, please email

The KPI Metrics project conducted a survey to test the acceptability of the KPIs and establish an initial benchmark set of metrics. The results have been published in a report which is now available to download here.

PhUSE Working Group Charter
Defining the operating guidelines for PhUSE Working Groups members


CSS Registration is now open, click here to register.

CS Collaboration Catalog of Deliverables

Working Group Quarterly Newsletters

PhUSE Webinars - Upcoming events and past presentations & recordings

Industry News

GDPR has gone live. Please review PhUSE Privacy Policy

The FDA now has a page dedicated to PhUSE on their Website. It provides an outline how FDA can evaluate and incorporate deliverables into FDA documentation in compliance with GPP

PhUSE & HL7 MOU October 2018

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

PhUSE / CDISC MOU has now been agreed and signed by both parties. Here's the current version.

Last revision by WendyDobson, 04/15/2019