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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<table align="center" style="font-size:125%;border-spacing:15px;width:100%;">
 
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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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<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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<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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[[Image:SDE_2019.jpg|500x500px|link=https://www.phuse.eu/single-day-events-2019]]<br>
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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'''<big>Pune, India March 28th </big>'''<br>
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[[image:US_Connect_2020.jpg||500x500px|link=https://www.phuse.eu/us-connect20]]<br>
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'''<big>Registration is still open </big>'''<br>
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[[Image:CSS_2020_Banner.jpg||500x500px|link=https://www.phuse.eu/css20]]<br>
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'''<big> Save the Date </big>'''<br>
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<!--------------------------------PhUSE Events---------------------------------->
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<!--------------------------------Become a PHUSE Member---------------------------------->
 
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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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<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>
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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>
 
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<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>
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*Participation in our annual US & EU Connects and the US Computational Science Symposium<br>
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<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>
 
 
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'''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>
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'''NEW''': Best Practices for writing PHUSE White Papers<br>
 
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Call for Papers closes '''12th January 2018'''<br>
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The PHUSE Steering Committee have produced guidelines on how to write a White Paper. Suggestions from length of the paper and writing style, to how best to keep your audience engaged are all useful tips. You can find the Best Practices [https://www.phusewiki.org/docs/WorkingGroups/Deliverables/Best%20Practices%20for%20Writing%20White%20Papers%20Jan%202020.pdf here]. <br>
Early Bird Registration closes '''26th January 2018'''
 
 
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In line with the Best Practices for writing White Papers, you will find the White Papers template [https://www.phuse.eu/useful-information here], together with plenty of other useful information to help support you and your project.<br>
 
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'''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>
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The Nonclinical Topics Working Group would be grateful if you could take a moment to assist in the annual data gathering by completing this [https://www.surveymonkey.co.uk/r/CFXJHQD short survey] on industry SEND (Standard for Exchange of Nonclinical Data) readiness and implementation. 
'''[http://www.phuse.eu/CSS-deliverables.aspx CS Collaboration Catalog of Deliverables]''' <br>
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The results of the teams recent efforts can help every organisation see where they are in relation to other organisations around the world that are striving to implement SEND solutions. Results will be published on the PHUSE Wiki and at the PHUSE Computational Science Symposium in June 2020. 
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This survey will close '''March 13th 2020'''.
 
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'''[http://www.phuse.eu/working-groups-quarterly Working Group Quarterly Newsletters]<br>
 
 
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'''[http://www.phuse.eu/webinars PhUSE Webinars] - Upcoming events and past presentations & recordings''''''<br>
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'''PHUSE Latest Deliverables''': <br>
 
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'''[http://www.phuse.eu/kpi-metricss-project Key Performance Indicators] (KPI)<br>
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The Best Practice for Submission of Event Adjudication Data has released a White Paper mapping out the common practices and challenges for submissions of event adjudication data. Click [https://www.phusewiki.org/docs/WorkingGroups/Deliverables/Best%20Practices%20for%20Submission%20of%20EA%20Data%20A4.pdf here] to download the paper.
 
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'''[http://www.phuse.eu/future-forum-wgs Future Forum]'''<br>
 
 
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'''[http://www.phuse.eu/data-transparency Data Transparency]'''<br>
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The Data Reviewer's Guide in XML project from the Optimising the Use of Data Standards Working Group have released v2.0 of the Prototype Package. This prototype release v2.0 package looks to provide a more stable version for industry early adoption and testing for a future final publication that encompasses all DRGs. Click [https://www.phusewiki.org/docs/WorkingGroups/Deliverables/DRG-XML%20V2.0/PHUSE%20DRG-XML%20Prototype%20Package%20Release%20v2.0%202.zip here] to download the full package. <br>
 
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'''Want to become a member of PhUSE? [http://www.phuse.eu/membership Here's how]'''<br>
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Log in to your PHUSE account and visit the [https://www.phuse.eu/blog members blog] to find a summary of all the latest news within the industry.<br>
 
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<!----------------------------------------Industry News------------------------------------------->
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<!-----------------------------Industry News------------------------------>
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<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>
 
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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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PHUSE Collaborations:<br>
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[https://www.cdisc.org CDISC]<br>
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[https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm482470.htm FDA]<br>
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[https://www.hl7.org HL7]<br>
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[https://www.psi-cro.com/?gclid=EAIaIQobChMIgbOorLTt4QIV7xXTCh0v9QDJEAAYASAAEgL_lfD_BwE PSI]<br>
 +
[https://www.stardog.com STARDOG]<br>
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<br>
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<br>
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Here's the [https://www.fda.gov/media/131872/download link] to the latest version of the Technical Conformance Guide ('''TCG''') which has been updated by the FDA October 2019<br>
 +
<br>
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*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>
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*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>
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*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 09:55, 21 January 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 6,844 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


SDE 2019.jpg

Pune, India March 28th

US Connect 2020.jpg

Registration is still open

CSS 2020 Banner.jpg

Save the Date


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



NEW: Best Practices for writing PHUSE White Papers

The PHUSE Steering Committee have produced guidelines on how to write a White Paper. Suggestions from length of the paper and writing style, to how best to keep your audience engaged are all useful tips. You can find the Best Practices here.

In line with the Best Practices for writing White Papers, you will find the White Papers template here, together with plenty of other useful information to help support you and your project.


The Nonclinical Topics Working Group would be grateful if you could take a moment to assist in the annual data gathering by completing this short survey on industry SEND (Standard for Exchange of Nonclinical Data) readiness and implementation. 

The results of the teams recent efforts can help every organisation see where they are in relation to other organisations around the world that are striving to implement SEND solutions. Results will be published on the PHUSE Wiki and at the PHUSE Computational Science Symposium in June 2020. 

This survey will close March 13th 2020.

PHUSE Latest Deliverables:

The Best Practice for Submission of Event Adjudication Data has released a White Paper mapping out the common practices and challenges for submissions of event adjudication data. Click here to download the paper.

The Data Reviewer's Guide in XML project from the Optimising the Use of Data Standards Working Group have released v2.0 of the Prototype Package. This prototype release v2.0 package looks to provide a more stable version for industry early adoption and testing for a future final publication that encompasses all DRGs. Click here to download the full package. 

Log in to your PHUSE account and visit the members blog to find a summary of all the latest news within the industry.



Industry News

GDPR has gone live. Please review PHUSE Privacy Policy

PHUSE Collaborations:

CDISC
FDA
HL7
PSI
STARDOG


Here's the link to the latest version of the Technical Conformance Guide (TCG) which has been updated by the FDA October 2019




Last revision by Laurenwhite, 01/21/2020