PhUSE Wiki

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.

PhUSE Website	Steering Committee	Useful Information	GPP

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Currently 6,783 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 wendy@phuse.eu PhUSE Events Registration Opens 31st January 3 SDE's scheduled for March Registration opens end of February Registration still open 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

Create a new Wiki page Enter the page title: 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 Industry News GDPR has gone live. Please review PhUSE Privacy Policy 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 Refuse to File: NDA & BLA Submissions to CDER. Guidance for Industry. Formal meetings between FDA and Sponsors or Applicants of PDUFA Products Best Practices for communication between IND Sponsors and FDA during Drug Development PhUSE / CDISC MOU has now been agreed and signed by both parties. Here's the current version.

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Last revision by Laurenwhite, 01/18/2019