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 6,854 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
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- Free attendance to a range of Single Day Events held across US, EU and Asia
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- Full access to PHUSE Archives
- Participation in our annual US & EU Connects and the US Computational Science Symposium
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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 21st - 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 interested in joining this project as a team member or as a co-lead contact firstname.lastname@example.org
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.
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, 03/31/2020