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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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Fridays @ 09:00 EDT, 14:00 BST. Check website for upcoming presentations

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Going Virtual. Check website for updates

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Registration to open shortly

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Registration and Call for Papers Opens 1st June

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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
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  • Participation in our annual US & EU Connects and the US Computational Science Symposium

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Working Groups News

Deliverables out for public comment:

Integration Strategies in Support of ISS/ISE Submissions Project has produced a White Paper and is currently seeking public feedback. The closing date is 15th June.

This paper describes data integration strategy recommendations by the PHUSE SDTM/ADaM Implementation FAQ Project to support the Integrated Summary of Safety (ISS) and the Integrated Summary of Efficacy (ISE).

Data De-Identification Standards project has produced a White Paper on Data Anonymisation and Risk Assessment Automation and is currently seeking public feedback. The closing date is 5th June.

The objective of this paper is to draw a detailed dataset(s) anonymisation process map, identify 6 challenges and potential pitfalls of the process, suggest best practices and offer automation ideas and 7 examples

Real World Evidence Project are currently seeking public feedback. The closing date is 5th June.

Usage of RWE in clinical trials for regulatory submissions is an area of research interest, due to the advantages in cost, cohort sizes and ethical considerations. This paper attempts to collate all related information such as sources of RWD privacy laws & 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. We begin with a summary of the RWE landscape before diving into some examples. The paper also lists FDA’s current thinking about the topic as of the date of this publication.

Final Published Deliverables

The Best Practices for Quality Control and Validation project have produced a White Paper which details the concepts, best practices and methods for quality control and validation of analysis programming used for clinical trials. Click here to download the paper.

The Data Transparency team conducted a review of the Modernisation of via the National Library of Medicine. The documented review can be found on the PHUSE website.

The Impacts of COVID-19 on Clinical Trial Transparency and Document Disclosure PHUSE CTT Project Blog

As the COVID-19 pandemic severely impacts many facets of human activity around the world, the pharmaceutical industry is being presented with significant challenges related to the manufacturing and shipping of existing marketed products and to treatment development activities. Regulatory authorities have released guidance documents focusing on the impacts to study start-up activities, changes to ongoing study procedures, and items considered urgent safety matters during this pandemic. This blog considers the impacts of COVID-19 on clinical study disclosure and transparency, offering guidance from industry experts on what may require immediate action, as well as consideration of future implications. To read the blog in full, click this link.

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, 05/20/2020