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 6,825 users are helping to Connect, Share, Advance clinical informatics.
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Working Group News
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 firstname.lastname@example.org 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.
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 email@example.com to join!
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
Here's the link to the latest version of the Technical Conformance Guide (TCG) which has been updated by the FDA March 2019
Last revision by WendyDobson, 08/19/2019