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 6,861 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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- Participation in our annual US & EU Connects and the US Computational Science Symposium
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Working Groups News
Working Groups Summer Blog
The Working Groups Summer Blog is now live! We’ve plenty of new and exciting updates to share, click here to read.
Final Published Deliverables
Since non-interventional study data do not necessarily need to be submitted to a regulatory agency, such as the FDA, there is no strict requirement for data standards.The Data Standards for Non-interventional Studies project has developed a White Paper which looks to identify the most common data standards challenges programmers experience while working on non-interventional studies and to suggest the means to deal with these challenges. Click here to read the paper.
The Optimising the Use of Data Standards – Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Project has published a White Paper. The paper aims to share submission experiences and develop best practices including submission strategy and planning, regulatory requirements, and interactions with the regulators.
PHUSE convened a group of experts from across industry to address the particular challenges Clinical Data Scientists may face in their work. This group has published a White Paper which offers perspectives from industry experts on what Clinical Data Scientists can expect in studies in COVID-19 and strategies to address some of the challenges they may encounter. This group has also published a series of blogs providing timely advice as well as an additional White Paper that considers the impacts of COVID-19 on the collection and analysis of clinical trial data.
The SDTM ADaM Implementation FAQ project has published responses to questions submitted on Data Submissions.
Deliverables out for Public Comment
PHUSE Working Groups Projects are soliciting feedback from the broader community on a wide range of deliverables. Click here to review the documents and provide your feedback.
The PHUSE Japan Working Groups are hosting a Webinar on October 8th. The Webinar, which will be in Japanese will cover the following topics;
- PHUSE Updates - Japan Working Groups and Japan Single Day Event in December
- Explore the Potential Value of Real-world Data by Using MDV Services
- Next Generation Medical Infrastructure Act: Full Scale Operation to Create Evidence
Register here' October 8th 2020, 16:00 (JST) 8:00 (BST) 3:00 (EDT)
Last revision by Laurenwhite, 09/24/2020