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 6,808 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 is open May Events: London UK, Bejing China, Hyderabad India Registration is open, Early Bird closes 26th July 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 NewThe detailed agenda for the upcoming CSS is now available to download. Click here to view the agenda and plan the sessions you would like to attend. New: We are pleased to announce that Dhananjay Chhatre known as DJ, will now be working alongside Andy Richardson Co-leading the Emerging Trends and Technologies Working Group. DJ is currently Associate Director at Gilead Sciences and has previously Co-lead the Optimising the Use of Data Standards Working Group. DJ comes with a wealth of knowledge and PhUSE experience. Information On June 12, 2019, Health Policy at Duke University will convene a public workshop to consider key implementation challenges and potential opportunities to advance the development and application of analysis data standards. To register for the conference which is working in cooperation with the FDA follow this link. Information: Effective 30th April, our distribution list forum Listbox will no longer be active. PhUSE office will manage communications so please send content to workinggroups@phuse.eu for distribution on your behalf. New: The Standard Analyses and Code Sharing Working Group are calling for volunteers to participate in the Good Programming Practice in Macro Development Project. The team looking to develop a Guideline / White Paper for creating well-structured and precisely documented macro code that will be easy to read and maintain over time. 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.  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! 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 PhUSE Collaborations: CDISC FDA HL7 PSI STARDOG 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

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Last revision by Laurenwhite, 05/20/2019