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.
Currently 6,858 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 firstname.lastname@example.org
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
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Working Groups News
CSS 2020 Update
The PHUSE Board and the PHUSE Office have worked tirelessly to examine and evaluate all possible options to determine the best way forward. In collaboration with the FDA, we will be postponing the CSS from June until 20th - 23rd September. It is our current working assumption that travel restrictions will be lifted by the second half of the year and the event will be able to go ahead at this later date. More information will be shared through the Working Groups and directly with the sponsors. For more information on Single Day and Connect events, visit the PHUSE website.
We'd like to take this opportunity to thank you all for your understanding and continued support.
NEW: Call for volunteers
Do you have experience with Ontology Development and Linked Data? The Study Data Validation and Submission Conformance project replaces its predecessor "Going Translational With Linked Data (GoTWLD)", extending existing work in both clinical and preclinical areas by further developing the data models and instance data conversion. The project will include modeling FDA Technical Rejection Criteria to facilitate submission of data to the FDA.
If you're interest in joining this project as a team member or as a co-lead contact email@example.com
NEW: Best Practices for writing PHUSE White Papers
The PHUSE Steering Committee have produced guidelines on how to write a White Paper. Suggestions from length of the paper and writing style, to how best to keep your audience engaged are all useful tips. You can find the Best Practices here.
In line with the Best Practices for writing White Papers, you will find the White Papers template here, together with plenty of other useful information to help support you and your project.
The Nonclinical Topics Working Group would be grateful if you could take a moment to assist in the annual data gathering by completing this short survey on industry SEND (Standard for Exchange of Nonclinical Data) readiness and implementation.
The results of the teams recent efforts can help every organisation see where they are in relation to other organisations around the world that are striving to implement SEND solutions. Results will be published on the PHUSE Wiki and at the PHUSE Computational Science Symposium in June 2020.
This survey will close March 30th 2020.
PHUSE Latest Deliverables:
NEW The PHUSE Investigating Endpoint Modeling project have released a White Paper which looks to provide recommendations for modeling of anti-drug antibody (ADA) data utilising the existing domains and variables available in the CDISC SEND Implementation Guide (SENDIG v3.0), and the use of custom domains and nonstandard variables adapted from the SDTMIG to be used with SENDIG v3.1. Click here to download the paper.
The Data Visualisation project conducted an updated analysis of the current tools used to review subject level data, including the use of interactive visualisations for generating patient profiles and patient narratives. This paper focuses on three types of subject level data representations:Tabular Patient Profiles, Graphical Patient Profiles and Patient Narratives. Click here to view the White Paper.
The Data Reviewer's Guide in XML project from the Optimising the Use of Data Standards Working Group have released v2.0 of the Prototype Package. This prototype release v2.0 package looks to provide a more stable version for industry early adoption and testing for a future final publication that encompasses all DRGs. Click here to download the full package.
Log in to your PHUSE account and visit the members blog to find a summary of all the latest news within the industry.
Here's the link to the latest version of the Technical Conformance Guide (TCG) which has been updated by the FDA October 2019
Last revision by WendyDobson, 03/17/2020