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.
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Working Group News
New The Demystifying Define-XML Codelist for Nonclinical Studies project has provided recommendations for specific problems/questions encountered, when fulfilling the define.xml codelist section for nonclinical studies. To view the projects recommendations visit the SEND Implementation Wiki page.
New: Data Standards for Non-Interventional Studies project would like to reach out to you again and ask you for your input. We are now trying to get an overview of the challenges you have faced from the perspective of implementation of CDISC standards for non-interventional studies. If you have tried to implement ADaM and/or SDTM for non-interventional studies, please take a few minutes to complete this very short survey. Your feedback is very much appreciated! This survey closes 26th April.
New The PhUSE Optimizing the Use of Data Standards Working Group has published a White Paper on Best Practices for Documenting Dataset Metadata: Define-XML Versus Reviewer’s Guide. Click here to view the paper.
If you are interested in contributing to one of our projects, please email firstname.lastname@example.org
The KPI Metrics project conducted a survey to test the acceptability of the KPIs and establish an initial benchmark set of metrics. The results have been published in a report which is now available to download here.
PhUSE Working Group Charter
Defining the operating guidelines for PhUSE Working Groups members
CSS Registration is now open, click here to register.
CS Collaboration Catalog of Deliverables
Working Group Quarterly Newsletters
PhUSE Webinars - Upcoming events and past presentations & recordings
The FDA now has a page dedicated to PhUSE on their Website. It provides an outline how FDA can evaluate and incorporate deliverables into FDA documentation in compliance with GPP
PhUSE & HL7 MOU October 2018
Here's the link to the latest version of the Technical Conformance Guide (TCG) which has been updated by the FDA January 2019
PhUSE / CDISC MOU has now been agreed and signed by both parties. Here's the current version.
Last revision by WendyDobson, 04/15/2019