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 6,818 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 July Events: 18th Hoboken, New Jersey - 27th Bengaluru, India Registration is open, Early Bird closes 26th July Registration & Call for Papers 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 ANNOUNCEMENTS PhUSE Webinars - Upcoming events and past presentations & recordings Are you a PhUSE member? Log in to your account and visit the members blog to find a summary of CSS and all the latest news within the industry. EU Connect - With just 20 weeks to go, plans for our event are well underway. Register your place by 26th July to benefit from the discounted Early Bird rate. US Connect - Registration and Call for Papers are now open for the US Connect 2020, click here for more information. DELIVERABLES We currently have a deliverable out on public review. We encourage you to provide your feedback to the project leads by following the links below: Implement Traceability in CDISC Compliant Studies NEW PROJECTS Projects that would be grateful to receive additional support and input are calling for volunteers. If you are able to dedicate a minimum of one hour per week, please contact workinggroups@phuse.eu to sign up. Integrated SDTM and Integrated ADaM Reviewer’s Guide(s): The cSDRG and ADRG apply to a single study. Sponsors have used these templates when creating a reviewer’s guide for integrated SDTM and a reviewer’s guide for integrated ADaM data. The template has to be changed in order to document the information for multiple studies. There is an opportunity to create a template for integrated SDTM and integrated ADaM. The project team will determine if this can be accomplished in one reviewer’s guide or if there should be two separate reviewer’s guides. Deliverables include a template, completion guidelines, and example documents. Best Practices for Data Collection Instructions: CDISC’s CDASH team provides high level completion instructions related to the core data collection modules. The PhUSE Standard Analysis and Code Sharing Working Group has developed recommended displays (ie, tables and figures) and associated code for use for analysis for data common across therapeutic areas. This project team will network with CDISC and the Standard Analyses and Code Sharing Working Group to ensure alignment. 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, 07/17/2019