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 6,786 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 Now Open, Call for Posters closes 22nd March 2 SDE's scheduled for March Call for Papers Opens 1st March, Registration Opens 1st April 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 Projects calling for Volunteers: New - Educating for the Future - Data Science New - Emerging Trends & Technologies - Going Translational with Linked Data Educating for the Future - Data Engineering Optimizing the Use of Data Standards - CDISC Implementation Primer Standard Analyses & Code Sharing - Code Sharing (Repository) If you are interested in contributing to one of these projects, please email workinggroups@phuse.eu NEW The KPI Metrics project conducted a survey to test the acceptability of the KPIs and establish an initial benchmark set of metrics. The results have been published in a report which is now available to download here. NEW: PhUSE Working Group Charter Defining the operating guidelines for PhUSE Working Groups members NEW:The Nonclinical Topics Working Group would be grateful if you could take a moment to complete this short survey on Industry Send Implementation. The outcome of this survey will be presented at the PhUSE 2019 CSS in Silver Spring, June 9-11, then published for public access on the PhUSE Wiki and Website. ANNOUNCEMENTS CSS Registration is now open, click here to register. Download the CSS Flyer and view the agenda. 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 January 2019 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 WendyDobson, 02/15/2019