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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

PHUSE Events

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Click here to listen back and view the presentations

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Gone Virtual. Check website for updates

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Registration now open

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Registration now open! Early Bird closes 31st July

Become a PHUSE Member

There are many benefits to becoming a PHUSE member. Here's just a few reasons why you want to become part of something amazing

  • Free attendance to a range of Single Day Events held across US, EU and Asia
  • Access to PHUSE Blog
  • Full access to PHUSE Archives
  • Participation in our annual US & EU Connects and the US Computational Science Symposium

To become a member, sign up here

Create a new Wiki page

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Working Groups News

Final Published Deliverables

The Real World Evidence project has published a White Paper that attempts to collate all related information such as sources of RWD (Real-World Data), privacy laws and use cases in one document which can act as a reference point for individuals or companies who wish to design, conduct, and submit studies using RWE (Real-World Evidence). Click here to read the paper. 

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.

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 SDTM ADaM Implementation FAQ project has published responses to questions submitted on SDTM/ADaM IG Nuances and Data Submissions.
Calling for Volunteers

Microsoft Teams Power User (Volunteer)

PHUSE is actively looking for a Power User for its Microsoft Teams platform. PHUSE has placed Microsoft Teams in a central position for communication and collaboration amongst its staff and volunteers.  As Power User, you will act in the role of adviser to the key users of the Teams platform, helping PHUSE to get the most out of this environment. In addition, you will act as the first point of contact for queries from the Office regarding the technical operation of Microsoft Teams and will be first line support if any technical issues occur.   For further information click here. Please note the closing date for this post is 21st August, contact to apply.

Terminology Harmonisation in Data Sharing and Disclosure Deliverables Currently there is inconsistency in terminology used in the field of data sharing and disclosure. These inconsistencies exist across industry and regulatory agencies as well as within PHUSE and cause unnecessary confusion. This project aims to collect, align and standardise terminology and their definitions used in to be used in future PHUSE deliverables. Previous PHUSE deliverables as well as key publications in the field will be examined to create a proposal for a baseline list of terms and definitions to be used moving forward. contact to get involved.

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

GDPR has gone live. Please review PHUSE Privacy Policy

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 Laurenwhite, 07/24/2020