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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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Bloemfontein - 29th Nov, Durham - 5th Dec, Tokyo - 10th Dec

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Registration is open. Hotel selling out fast!

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Save the Date

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

We are pleased to announce a new Co-Lead for the Educating for the Future Working Group to work alongside James McDermott. Greg Silva, is a director of Statistical Programming at AstraZeneca and has a background in computer science. Greg is hoping to build career paths based on education and grow the next generation of Data Scientists and strategic thinkers

NEW As part of a FDA/PHUSE collaboration, the Best Practices for Data Collection Instructions project has created a survey on Adverse Events & Treatment Emergent, covering both data collection and analysis of adverse events. Click here to participate

The PHUSE Key Performance Indicators & Metrics Project has established a set of common data reporting metrics which are more detailed than industry-wide metrics, therefore allowing a greater level of granularity in our project reporting, and business process management.
These metrics and their definitions are issued annually as a survey to life sciences industry companies in order to collect their information. The Year 2 survey is now being distributed to collate information from 20+ companies. Should you wish your company to participate, contact

PHUSE Webinars - Upcoming events and past presentations & recordings


NEW 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.
NEW 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. 

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

US Connect - Registration is open, click here for more information

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 has been updated by the FDA October 2019

Last revision by Laurenwhite, 12/18/2019