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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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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

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

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Registration now open! Early Bird closes 31st July

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Working Groups News

Deliverables out for public comment:

The Analyses and Displays project has produced a White Paper and is currently seeking public feedback. The closing date is 10th July.

The White Paper is intended to provide recommendations on analyses and displays to sponsors who are planning analyses for Safety Topics of Interest for Phase 2-4 Clinical Trials and Integrated Summary documents (or other documents in which analyses of safety are of interest).

General Output Tips and Considerations project has produced a White Paper and is currently seeking public feedback. The closing date is 10th July.

This White Paper provides general advice on the display of data in tabular form. The intent is educational and not prescriptive as an aid to considering how to present data in tables.

Final Published Deliverables

The Data De-Identification Toolkit project has published a White Paper which draws a detailed dataset(s) anonymisation process map. The paper identifies challenges and potential pitfalls of the process, suggest best practices and offers automation ideas and examples. Click here to download.

The Global View of the Clinical Transparency Landscape Best Practices Guide builds upon the “Clinical Trial Transparency and Disclosure: A Global View” White Paper listed below. In this Best Practices Guide, subject matter experts share recommendations with the aim of fostering a holistic approach to clinical data transparency and disclosure that provides accurate and complete information across multiple disclosure platforms.

The Clinical Trial Transparency and Disclosure: A Global View White Paper was developed by industry experts with the goal of highlighting the evolving global landscape of clinical trial transparency and disclosure, with special focus on individual study and submission-related requirements. Click here to download the paper.

Calling for Volunteers

Harmonization of SEND Implementation to Enable Historical Control Data Analysis The scope of this project is to evaluate and recommend approaches for SEND harmonization to better enable analysis of historical control data. SEND harmonization strategies include creation of new variables, controlled terminology, preferred terms, reference lists and/or analysis strategies (scripts) to enable cross study analysis. Developing a solution framework for variability that includes representation of stakeholders involved in the creation and use of SEND datasets will enable more efficient routine analysis of warehoused SEND data. Harmonizing the implementation and use of SEND is expected to benefit all involved stakeholders and to ultimately contribute to the goal of increased productivity in nonclinical research.
contact to get involved.

Industry News

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PHUSE Collaborations

Here's the link to the latest version of the Technical Conformance Guide (TCG) which was updated by the FDA March 2020

Last revision by WendyDobson, 07/3/2020