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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Currently 6,813 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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July Events: 18th Hoboken, New Jersey - 27th Bengaluru, India

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Registration is open, Early Bird closes 26th July

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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

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Working Group News

New The detailed agenda for the upcoming CSS is now available to download. Click here to view the agenda and plan the sessions you would like to attend.

Information On June 12, 2019, Health Policy at Duke University will convene a public workshop to consider key implementation challenges and potential opportunities to advance the development and application of analysis data standards. To register for the conference which is working in cooperation with the FDA follow this link.

Information: Effective 30th April, our distribution list forum Listbox will no longer be active. PhUSE office will manage communications so please send content to for distribution on your behalf.

New: The Standard Analyses and Code Sharing Working Group are calling for volunteers to participate in the Good Programming Practice in Macro Development Project. The team looking to develop a Guideline / White Paper for creating well-structured and precisely documented macro code that will be easy to read and maintain over time.

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


CS Collaboration Catalog of Deliverables

Working Group Quarterly Newsletters

PhUSE Webinars - Upcoming events and past presentations & recordings

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 January 2019

Last revision by WendyDobson, 06/4/2019