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 6,664 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 Industry News GDPR has gone live. Please review PhUSE Privacy Policy and contact the PhUSE Office at office@phuse.eu if you have any queries. 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 March 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. PhUSE Events

Create a new Wiki page Enter the page title: Working Group News The Working Groups now have a latest news page! Click here to view updates around the PhUSE working groups, from workshops to white papers, projects news and industry views. NEW - Blockchain Technology project have now published their White Paper on 'How Blockchain Can Transform the Pharmaceutical and Healthcare Industries'. Click here to view the paper. PhUSE Standard Operating Procedure on version control for PhUSE deliverables 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 Want to become a member of PhUSE? Here's how

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Last revision by Laurenwhite, 07/25/2018