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 6,825 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 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 Group News ANNOUNCEMENTS PhUSE Webinars - Upcoming events and past presentations & recordings Are you interested in helping drive new and innovative solutions in the area of computational science? We are currently seeking two volunteers to serve as industry members of the Steering Committee. These members are crucial in helping the Working Groups attain their goals, by providing an industry perspective across all of the Working Groups activities. For further information, please see the Steering Committee Charter or feel free to contact ChrisPrice, PHUSE Working Groups Director, at chris.price@phuse.eu to discuss the role in more detail. The Optimising the Use of Data Standards Working Group has released a new version of the Analysis Data Reviewer’s Guide (ADRG). The ADRG provides FDA Reviewers with additional context for analysis datasets (AD) received as part of a regulatory submission. The ADRG purposefully duplicates limited information found in other submission documentation (e.g., the protocol, statistical analysis plan, clinical study report, define.xml) in order to provide FDA Reviewers with a single point of orientation to the analysis datasets. 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 14 weeks to go, plans for our event are well underway. Discounted hotel rates are limited, register here. US Connect - Registration and Call for Papers are now open for the US Connect 2020, click here for more information. New Project:  The Nonclinical WG has a new project calling for volunteers. The SEND Dataset QC Best Practices looks to  Explore the variety of QC procedures and tools among different stakeholders Identify practical amount of QC checking of SEND datasets (including the QC checks for the comparison of SEND datasets and the study report) Identify a suite of tools and procedures (e.g. visualization, documentation, etc) for QC Develop recommendations for stakeholders for efficient and effective SEND QC practices and, in the long term, for starting a foundation of commonly agreed QC procedures Email workinggroups@phuse.eu to join!  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: Recommendations for ADA Modelling in SEND 3.0 and 3.1 Data Transparency Working Group Recommendations for GDPR Compliancy 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 March 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

---

Last revision by Laurenwhite, 08/12/2019