Difference between revisions of "PHUSE Wiki"

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<div style="background:#D8E8FF; border-bottom:1px solid #8898BF; padding:0.2em 0.5em; font-size:125%; font-weight:bold;"><p style="text-align:center; margin:0px;">Welcome to the PhUSE Wiki</p></div>
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<div style="background:#D8E8FF; border-bottom:1px solid #8898BF; padding:0.2em 0.5em; font-size:125%; font-weight:bold;"><p style="text-align:center; margin:0px;">Welcome to the PHUSE Wiki</p></div>
  
 
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<p style="text-align:center;">The PhUSE Wiki is an [http://www.phuse.eu PhUSE]/FDA/Industry collaboration to provide a medium to share information specifically relating to clinical trial informatics.</p>
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<p style="text-align:center;">The PHUSE Wiki is an [http://www.phuse.eu PHUSE]/FDA/Industry collaboration to provide a medium to share information specifically relating to clinical trial informatics.</p>
  
 
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         <th><big>'''[http://www.phuse.eu Phuse Web Page]'''</big></th>
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         <th><big>'''[http://www.phuse.eu PHUSE Website]'''</big></th>
         <th><big>'''[[Computational_Science_Working_Group_Steering_Committee|CS Steering Committee]]'''</big></th>
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         <th><big>'''[[Computational_Science_Working_Group_Steering_Committee|Steering Committee]]'''</big></th>
         <th><big>'''[[CSS Working Groups|CSS Working Groups]]'''</big></th>
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         <th><big>'''[[CSS Working Groups|Useful Information]]'''</big></th>
 
         <th><big>'''[[Good_Programming_Practice_Guidance|GPP]]'''</big></th>
 
         <th><big>'''[[Good_Programming_Practice_Guidance|GPP]]'''</big></th>
 
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[[Image:PhUSE_Web_Page_Wiki.jpg|center|top|200px||link=http://www.phuse.eu ]]  
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[[Image:CSS_Working_Groups_Wiki.jpg|center|top|190px|link=CSS Working Groups]]
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[[Image:CSS_Working_Groups_Wiki.jpg|center|top|190px|link=https://www.phusewiki.org/wiki/index.php?title=General]]
 
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<p style="text-align:center;vertical-align:top;"><big>'''[[Listbox_Instructions|Join a Working Group now!]]'''</big></p>
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<div style="font-size:100%;color:#ff8c00"><p style="text-align:center;">Currently {{NUMBEROFUSERS}} users are helping to <big>'''''Connect, Share, Advance'''''</big> clinical informatics.</p></div><br/>
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<div style="font-size:100%;color:#ff8c00"><p style="text-align:center;">Currently {{NUMBEROFUSERS}} users are helping to <big>'''''Share, Contribute and Advance'''''</big> clinical informatics.</p></div><br/>
 
 
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</div>
<center>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 [[PhUSEWiki:General_disclaimer|Disclaimers]] page.</center>
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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 [[PhUSEWiki:General_disclaimer|Disclaimers]] page
  
 
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<!-----------------------------What is this place------------------------------>
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<!--------------------------------Need help with the Wiki? Ideas on Improving?---------------------------------->
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<div style="background:#D8E8FF; border-bottom:1px solid #8898BF; padding:0.2em 0.5em; font-size:125%; font-weight:bold;">What is this place?</div>
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<div style="background:#D8E8FF; border-bottom:1px solid #8898BF; padding:0.2em 0.5em; font-size:125%; font-weight:bold;">Need help with the Wiki? Ideas to Improve?</div>
 
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The PhUSE Wiki is an [http://www.phuse.eu PhUSE]/FDA/Industry collaboration to provide a medium to share information specifically relating to clinical trial informatics. The wiki has three main goals:<br />
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<big>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 '[http://www.phusewiki.org/wiki/index.php?title=Have_a_Wiki_Question%3F_Need_help%3F_Use_this_forum_to_ask_you_question '''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 wendy@phuse.eu </big><br>
#To support the [[FDA Working Groups|Computational Science Symposium (CSS) Working Groups]] by creating an online collaboration environment.
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#To support the [[Standard Scripts|sharing]] of statistical and informatics software code (SAS,R etc).
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#To serve as a medium to share information related to software programming and processes for pharmaceutical, biotech, CRO, medical device and health care programmers.
 
 
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<!--------------------------------What Can I do here?---------------------------------->
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<!--------------------------------PHUSE Events---------------------------------->
 
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<div style="background:#D8E8FF; border-bottom:1px solid #8898BF; padding:0.2em 0.5em; font-size:125%; font-weight:bold;">What can I do here?</div>
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<div style="background:#D8E8FF; border-bottom:1px solid #8898BF; padding:0.2em 0.5em; font-size:125%; font-weight:bold;">PHUSE Events</div>
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Well that depends who you are.  If you are a  '''[[FDA Working Groups|CSS Working Group member you can click here]]''' to access your specific working group.  If you are '''[[Annual_Conference|authoring a wiki for the PhUSE Annual Conference you can click here]]'''.Otherwise, if you have something to share, enter the title of your page into the box at the right.  If you are looking for something, use the search at the top right of this page.
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Start by  '''[[Special:UserLogin|creating a User account]]'''. In order to keep this Wiki transparent for all users it would be great if you could '''use your real name as your user name'''. Note that you also need to create a User account if you are a PhUSE member. '''Your PhUSE login details do not work here.''' It might also be good to familiarize yourself with the '''[[Help|wiki language]]'''.  After that, you are welcome to add, edit, read, and discuss anything in this wiki.  If you have questions, please '''[mailto:wikiadmin@phusewiki.org contact us]''' . Interested, but don't know which topic to tackle? Check out the '''[[Special:WantedPages|Wanted]]''' pages.  Make someone's day by answering their question.
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[[Image:PHUSE-FDA_Challenge.jpg|500x500px|link=https://www.phuse.eu/phuse-fda-data-science-innovation-challenge]]<br>
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<br>
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'''<big>Click [https://www.phuse.eu/phuse-fda-data-science-innovation-challenge here] to listen back and view the presentations</big>''' <br>
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<br>
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[[Image:Virtual_SDE_banner.jpg|500x500px|link=https://www.phuse.eu/sde20]]<br>
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'''<big>Gone Virtual. Check website for updates </big>'''<br>
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[[image:EU_Connect_Virtual_2020.jpg||500x500px|link=https://www.phuse-events.org/attend/frontend/reg/thome.csp?pageID=256&eventID=2&traceRedir=2]]<br>
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'''<big>[https://www.phuse-events.org/attend/frontend/reg/tRegisterEmailNew.csp?pageID=332&ef_sel_menu=189&eventID=2&tempPersonID=1246 Registration] now open. Early Bird closes 28th August </big>'''<br>
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[[Image:-23098 PHUSE CSS 2020 Virtual - Banner Standard Size v1.jpg||500x500px|link=https://www.phuse-events.org/attend/frontend/reg/thome.csp?pageID=1068&eventID=3&traceRedir=2]]<br>
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'''<big> [https://www.phuse-events.org/attend/frontend/reg/tRegisterEmailNew.csp?pageID=968&ef_sel_menu=72&eventID=3&tempPersonID=1239 Registration] now open </big>'''<br>
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<!--------------------------------PhUSE Events---------------------------------->
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<!--------------------------------Become a PHUSE Member---------------------------------->
 
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<div style="border:1px solid #8898BF">
<div style="background:#D8E8FF; border-bottom:1px solid #8898BF; padding:0.2em 0.5em; font-size:125%; font-weight:bold;">PhUSE Events</div>
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<div style="background:#D8E8FF; border-bottom:1px solid #8898BF; padding:0.2em 0.5em; font-size:125%; font-weight:bold;">Become a PHUSE Member</div>
<div style="padding:0.5em 0.5em 0.5em 0.5em;">
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[[Image:Single Day Events 100.jpg|500x500px|link=http://www.phuse.eu/Single-Day-Events.aspx]]
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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<br>
 
+
<br>
[[Image:Frankfurt_Connect_Web_Banner.jpg|500x500px|link=http://www.phuse.eu/eu-connect18]]
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*Free attendance to a range of Single Day Events held across US, EU and Asia<br>
 
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*Access to PHUSE Blog <br>
[[Image:PhUSE_Raleigh_2018_Web_Banner.jpg||500x500px|link=http://www.phuse.eu/us-connect18]]
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*Full access to PHUSE Archives<br>
 +
*Participation in our annual US & EU Connects and the US Computational Science Symposium<br>
 +
<br>
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To become a member, sign up '''[https://www.phuse.eu/membership here]'''<br>
 
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<!----------------------------------------News Updates------------------------------------------->
 
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<div style="background:#D8E8FF; border-bottom:1px solid #8898BF; padding:0.2em 0.5em; font-size:125%; font-weight:bold;">Working Group News</div>
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<div style="background:#D8E8FF; border-bottom:1px solid #8898BF; padding:0.2em 0.5em; font-size:125%; font-weight:bold;">Working Groups News</div>
 
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[[Image:US_CSS_2018_Web_Banners.jpg|500x500px|link=http://www.phuse.eu/css18]]<br>
 
 
<br>
 
<br>
'''Registration is now open for the CSS 2018 event 4th - 6th March, Silver Spring, Maryland. Follow this [https://www.phuse.eu/phuse-css-2018-registration link] to register.'''<br>
 
 
<br>
 
<br>
Call for Papers closes '''12th January 2018'''<br>
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'''Final Published Deliverables''' <br>
Early Bird Registration closes '''26th January 2018'''
 
 
<br>
 
<br>
 +
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 [https://phusewiki.org/docs/WorkingGroups/Deliverables/PHUSE%20Deliverables%20Jul%202020%20%E2%80%93%20Basic%20Considerations%20for%20the%20Use%20of%20RWE.pdf here] to read the paper. <br>
 
<br>
 
<br>
'''Calling all volunteers'''. Are you interested in joining one of the new projects recently approved by the CS Steering Committee?. This [http://www.phuse.eu/cs-new-project-ideas link] will take you to an overview of the latest projects looking for members.<br>
 
 
<br>
 
<br>
'''[http://www.phuse.eu/CSS-deliverables.aspx CS Collaboration Catalog of Deliverables]''' <br>
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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 [https://phusewiki.org/docs/WorkingGroups/Deliverables/Data%20Anonymisation%20%26%20Risk%20Assessment%20Automation%20-%20Data%20Transparency.pdf here] to download. <br>
 
<br>
 
<br>
'''[http://www.phuse.eu/working-groups-quarterly Working Group Quarterly Newsletters]<br>
 
 
<br>
 
<br>
'''[http://www.phuse.eu/webinars PhUSE Webinars] - Upcoming events and past presentations & recordings''''''<br>
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'''Deliverables out for Public Comment''' <br>
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PHUSE Working Groups Projects are soliciting feedback from the broader community on a wide range of deliverables. Click [https://www.phuse.eu/cs-deliverables-under-review here] to review the documents and provide your feedback.<br>
 
<br>
 
<br>
'''[http://www.phuse.eu/kpi-metricss-project Key Performance Indicators] (KPI)<br>
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The SDTM ADaM Implementation FAQ project has published responses to questions submitted on [[SDTM_FAQ_Team_Responses#Topic:_SDTM.2FADaM_IG_Nuances_.28IGN_Sub-Team.29|SDTM/ADaM IG Nuances]] and [[SDTM_FAQ_Team_Responses#Topic:_Data_Submissions_.28DSUB_Sub-Team.29|Data Submissions]].
 
<br>
 
<br>
'''[http://www.phuse.eu/future-forum-wgs Future Forum]'''<br>
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'''Calling for Volunteers''' <br>
 
<br>
 
<br>
'''[http://www.phuse.eu/data-transparency Data Transparency]'''<br>
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'''Microsoft Teams Power User (Volunteer)'''
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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 [https://www.phuse.eu/documents//working-groups/microsoft-teams-power-user-job-spec-29802.docx here]. Please note the closing date for this post is 21st August, contact workinggroups@phuse.eu to apply.<br>
 
<br>
 
<br>
'''Want to become a member of PhUSE? [http://www.phuse.eu/membership Here's how]'''<br>
 
 
<br>
 
<br>
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[[Terminology_Harmonisation_in_Data_Sharing_and_Disclosure_Deliverables|'''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 workinggroups@phuse.eu to get involved.'''<br>
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<br>
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<br>
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'''[[Harmonization_of_SEND_Implementation_to_Enable_Historical_Control_Data_Analysis|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.<br>
 +
'''contact workinggroups@phuse.eu to get involved.'''
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<!----------------------------------------Industry News------------------------------------------->
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<!-----------------------------Industry News------------------------------>
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<div style="border:1px solid #8898BF;">
 
<div style="background:#D8E8FF; border-bottom:1px solid #8898BF; padding:0.2em 0.5em; font-size:125%; font-weight:bold;">Industry News</div>
 
<div style="background:#D8E8FF; border-bottom:1px solid #8898BF; padding:0.2em 0.5em; font-size:125%; font-weight:bold;">Industry News</div>
 
<div style="padding:0.5em 0.5em 0.5em 0.5em;">
 
<div style="padding:0.5em 0.5em 0.5em 0.5em;">
Here's the [https://www.fda.gov/downloads/forindustry/datastandards/studydatastandards/ucm384744.pdf link] to the latest version of the Technical Conformance Guide ('''TCG''') which has been updated by the FDA October 2017
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GDPR has gone live. Please review '''[[PhUSEWiki:Privacy_policy|PHUSE Privacy Policy]]'''<br>
 
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<br>
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[https://www.phuse.eu/partnerships PHUSE Collaborations]<br>
 +
<br>
 +
Here's the [https://www.fda.gov/media/136460/download link] to the latest version of the Technical Conformance Guide ('''TCG''') which was updated by the FDA March 2020<br>
 +
<br>
 +
*Refuse to File: [https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM588242.pdf?utm_campaign=CDER%20New%2012%2F13 NDA & BLA Submissions to CDER]. Guidance for Industry.<br>
 +
*Formal meetings between [https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm590547.pdf FDA and Sponsors or Applicants] of PDUFA Products<br>
 +
*Best Practices for communication between [https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm475586.pdf IND Sponsors and FDA] during Drug Development<br>
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Last revision by {{REVISIONUSER}}, {{REVISIONMONTH}}/{{REVISIONDAY}}/{{REVISIONYEAR}}
 
Last revision by {{REVISIONUSER}}, {{REVISIONMONTH}}/{{REVISIONDAY}}/{{REVISIONYEAR}}

Latest revision as of 03:13, 3 August 2020

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.


PHUSE Website Steering Committee Useful Information GPP
Resized small logo.png
CS Steering Committee (Wiki).jpg
CSS Working Groups Wiki.jpg
Good Programming Practice Guidance Wiki.jpg

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 wendy@phuse.eu



PHUSE Events



PHUSE-FDA Challenge.jpg


Click here to listen back and view the presentations

Virtual SDE banner.jpg

Gone Virtual. Check website for updates

EU Connect Virtual 2020.jpg

Registration now open. Early Bird closes 28th August

-23098 PHUSE CSS 2020 Virtual - Banner Standard Size v1.jpg

Registration now open


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

Enter the page title:




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 workinggroups@phuse.eu 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 workinggroups@phuse.eu 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 workinggroups@phuse.eu 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 WendyDobson, 08/3/2020