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

Currently 6,837 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 Bloemfontein - 29th Nov, Durham - 5th Dec, Tokyo - 10th Dec Registration is open. Hotel selling out fast! Save the Date 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 Blog 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 Groups News ANNOUNCEMENTS We are currently seeking a volunteer to serve as a Co-Lead of the PHUSE Educating for the Future Working Group to work alongside James McDermott. Working Group Co-Leads are critical in providing leadership to the Working Group, supporting the delivery of the active projects and in contributing to the wider efforts of the PHUSE Working Groups. Within the Educating for the Future Working Group, we currently have three projects: an overview of each of these can be found here, together with expected deliverables and timelines. Additionally, to perform this role successfully, you will need to be able to commit to attending the monthly Steering Committee meetings and supporting its activities, as well as help contribute to the running of the Computational Science Symposium, which takes place in June in Silver Spring, Maryland, US. Those who are or have previously actively contributed to a PHUSE project are particularly encouraged to apply. We ask that all applicants interested in this role provide a brief summary of how you feel you can contribute to driving this Working Group forward. (We suggest about 200 words.) If you would like a more in-depth overview, please contact, in the first instance, James McDermott (james.mcdermott@achieveintelligence.com), our Working Group Co-Lead for Educating for the Future. All applications are to be submitted to workinggroups@phuse.eu. Closing date for applications is Wednesday 20th November. Deliverable out for Public Comment Best Practices for Quality Control & Validation: Closing date, 22nd November PHUSE Webinars - Upcoming events and past presentations & recordings NEWThe SEND Dataset QC Best Practices project is looking to develop recommendations for stakeholders for efficient and effective SEND QC practices. In order to explore the variety of QC procedures and tools among different stakeholders the team are asking members to participate in this short survey. This survey will close by the end of November.  New The PHUSE Key Performance Indicators & Metrics Project has established a set of common data reporting metrics which are more detailed than industry-wide metrics, therefore allowing a greater level of granularity in our project reporting, and business process management. These metrics and their definitions are issued annually as a survey to life sciences industry companies in order to collect their information. The Year 2 survey is now being distributed to collate information from 20+ companies. Should you wish your company to participate, contact workingroups@phuse.eu. New The Communications, Promotion & Education Project under the remit of the Standard Analyses & Code Sharing Working Group, have created a Code Repository front end on our PHUSE Education page. The vision is to establish and maintain a collaboration platform for leveraging crowd-sourcing to improve the content and implementation of analyses for medical research. Beyond providing important educational material and usage context for the Code Repository, the front end also highlights specific code and data packages for download that are mentioned in PHUSE final deliverables. Are you a PHUSE member? Log in to your account and visit the members blog to find a summary of all the latest news within the industry. US Connect - Registration is open, click here for more information 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 October 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 WendyDobson, 11/19/2019