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.

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Currently 6,798 users are helping to Connect, Share, Advance clinical informatics.

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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 is open April Events: Heidelburg, Germany - Foster City, California Call for Papers closes 26th April: Registration is open Registration & Call for Papers opens 1st July 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 The Demystifying Define-XML Codelist for Nonclinical Studies project has provided recommendations for specific problems/questions encountered, when fulfilling the define.xml codelist section for nonclinical studies. To view the projects recommendations visit the SEND Implementation Wiki page. New: Data Standards for Non-Interventional Studies project would like to reach out to you again and ask you for your input. We are now trying to get an overview of the challenges you have faced from the perspective of implementation of CDISC standards for non-interventional studies. If you have tried to implement ADaM and/or SDTM for non-interventional studies, please take a few minutes to complete this very short survey. Your feedback is very much appreciated! This survey closes 26th April. New The PhUSE Optimizing the Use of Data Standards Working Group has published a White Paper on Best Practices for Documenting Dataset Metadata: Define-XML Versus Reviewer’s Guide. Click here to view the paper. If you are interested in contributing to one of our projects, please email workinggroups@phuse.eu 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. PhUSE Working Group Charter Defining the operating guidelines for PhUSE Working Groups members ANNOUNCEMENTS CSS Registration is now open, click here to register. 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 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, 04/15/2019