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 6,783 users are helping to Connect, Share, Advance clinical informatics.
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Working Group News
NEW: PhUSE Working Group Charter
Defining the operating guidelines for PhUSE Working Groups members
Over the last few months the projects within the PhUSE Working Groups have been incredibly busy working on their deliverables. We currently have three White Papers out for public review. To view the papers and provide your feedback click here.
The Clinical Trials Data as RDF project have released their White Paper, click here, to view the document.
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.
The Script Metadata for Sharing project have now published their final White Paper which explores how to use recommended script metadata to increase the accessibility, reusability and automation of scripts. Click here to view the paper.
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
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
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.
Last revision by Laurenwhite, 01/18/2019