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 6,780 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

Industry News

GDPR has gone live. Please review PhUSE Privacy Policy and contact the PhUSE Office at if you have any queries.

PhUSE & HL7 MOU October 2018

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 October 2018

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

PhUSE Events

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Working Group News

Over the last few months the projects within the PhUSE working groups have been incredibly busy working on their deliverables. We currently have four White Papers out for public review. To view the papers and provide your feedback click here.

The Optimising the Use of Data Standards Working Group have now published the final cSDRG which includes the Clinical Legacy Data Conversion Plan & Report section. To view the deliverables click here.

The Test Data Factory project have now released their final document which looks to create CDISC-compliant test datasets focusing on SDTM, ADaM, and SEND. Click here to view the referenced documents.

Define XML 2.0 Stylesheet Recommendations have released their final standard document, to view the files click here.

The Clinical Trials Data Transparency Toolkit project have released their final White Paper which looks to highlight the evolving global landscape of clinical trial transparency and disclosure. Click here to view the paper and the supporting documents.

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

Last revision by Laurenwhite, 12/14/2018