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 6,814 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

What is this place?

The PhUSE Wiki is an PhUSE/FDA/Industry collaboration to provide a medium to share information specifically relating to clinical trial informatics. The wiki has three main goals:

  1. To support the Computational Science Symposium (CSS) Working Groups by creating an online collaboration environment.
  2. To support the sharing of statistical and informatics software code (SAS,R etc).
  3. To serve as a medium to share information related to software programming and processes for pharmaceutical, biotech, CRO, medical device and health care programmers.

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Working Group News

Pooling WHOB3 Format White Paper is currently on public review. Should you wish to review and comment, click here

The Future Forum Project Team have now published their deliverables on 'The Job Description for a Clinical Data Scientist. Follow this link to review

NEW Standard Analyses and Code Sharing Working Group has now published Version 2:0 White Paper on Analyses & Displays Associated with Demographics, Disposition, and Medications in Phase 2-4 Clinical Trials and Integrated Summary Document. Click here for the revised version under White Papers

NEW - PhUSE Standard Operating Procedure on version control for PhUSE deliverables

NEW Optimising the Use of Data Standards Working Group are pleased to announce the publication of the Study Data Standardised Plan, Sponsor Implementationn and relevant Template. Click here for the deliverables.

Calling all volunteers. Are you interested in joining one of the new projects recently approved by the CS Steering Committee?. This link will take you to an overview of the latest projects looking for members.

CS Collaboration Catalog of Deliverables

Working Group Quarterly Newsletters

PhUSE Webinars - Upcoming events and past presentations & recordings'

Want to become a member of PhUSE? Here's how

Industry News

FDAs Website now has a page referencing PhUSE and their deliverables which can be found here

Here's the link to the latest version of the Technical Conformance Guide (TCG) which has been updated by the FDA March 2018

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

Last revision by WendyDobson, 05/17/2018