Difference between revisions of "PhUSE Wiki"

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         <th><big>'''[http://www.phuse.eu PhUSE Website]'''</big></th>
 
         <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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       </tr>
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</div>
 
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<br/>
<!-----------------------------Industry News------------------------------>
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<!--------------------------------PhUSE Events---------------------------------->
<div style="border:1px solid #8898BF;">
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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>
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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>
<div style="padding:0.5em 0.5em 0.5em 0.5em;">
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<div style="padding:0.5em 0.5em 0.5em 0.5em;"><br>
GDPR has gone live. Please review '''[[PhUSEWiki:Privacy_policy|PhUSE Privacy Policy]]''' and contact the PhUSE Office at office@phuse.eu if you have any queries.<br>
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[[Image:CSS_2019_Banner_.jpg|500x500px|link=https://www.phuse.eu/css19]]<br>
 
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<br>
FDAs Website now has a page referencing PhUSE and their deliverables which can be found [https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm482470.htm here] <br>
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'''<big>Registration Now Open, Call for Posters closes 22nd March</big>''' <br>
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<br>
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[[Image:SDE_2018_Standard_Banner.jpg|500x500px|link=https://www.phuse.eu/single-day-events-2019]]<br>
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'''<big>2 SDE's scheduled for March</big>'''<br>
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[[Image:2019_EU_Connect_.jpg|500x500px|link=https://www.phuse.eu/eu-connect19]]<br>
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'''<big>Call for Papers Opens 1st March, Registration Opens 1st April</big>'''<br>
 
<br>
 
<br>
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 March 2018<br>
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[[Image:2019_US_Connect_Website_Banner.jpg|500x500px|link=http://www.phuse.eu/us-connect19]]<br>
 
<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>
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'''<big>Registration still open</big>'''<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>
 
 
<br>
 
<br>
PhUSE / CDISC MOU has now been agreed and signed by both parties. Here's the current [http://www.phusewiki.org/wiki/images/6/67/PhUSE_CDISC_MOU_2018_to_2019.pdf version].
 
 
</div>
 
</div>
 
</div>
 
</div>
<br/>
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<br>
<!--------------------------------PhUSE Events---------------------------------->
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<!--------------------------------Become a PhUSE Member---------------------------------->
 
<div style="border:1px solid #8898BF">
 
<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;"><br>
 
<div style="padding:0.5em 0.5em 0.5em 0.5em;"><br>
[[Image:Single Day Events 100.jpg|500x500px|link=http://www.phuse.eu/single-day-events-2018]]<br>
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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>
 
<br>
[[Image:Frankfurt_Connect_Web_Banner.jpg|500x500px|link=http://www.phuse.eu/eu-connect18]]<br>
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*Free attendance to a range of Single Day Events held across US, EU and Asia<br>
 +
*Access to PhUSE News<br>
 +
*Full access to PhUSE Archives<br>
 +
*Participation in our annual US & EU Connects and the US Computational Science Symposium<br>
 
<br>
 
<br>
[[Image:PhUSE_Raleigh_2018_Web_Banner.jpg||500x500px|link=http://www.phuse.eu/us-connect18]]<br>
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To become a member, sign up '''[https://www.phuse.eu/membership here]'''<br>
 
</div>
 
</div>
 
</div>
 
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<br>
'''NEW''' - Pooling WHOB3 Format White Paper is currently on public review. Should you wish to review and comment, click [https://www.phuse.eu/cs-deliverables-under-review here]<br>
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'''[https://www.phuse.eu/cs-new-project-ideas Projects calling for Volunteers]''':<br>
 +
<br>
 +
'''New''' - Educating for the Future - Data Science<br>
 +
'''New''' - Emerging Trends & Technologies - Going Translational with Linked Data <br>
 +
Educating for the Future - Data Engineering<br>
 +
Optimizing the Use of Data Standards - CDISC Implementation Primer<br>
 +
Standard Analyses & Code Sharing - Code Sharing (Repository)<br>
 +
 
 +
<br>
 +
If you are interested in contributing to one of these projects, please email '''workinggroups@phuse.eu'''<br>
 +
<br>
 +
'''NEW''' The KPI Metrics project conducted a survey to test the acceptability of the KPIs and establish an initial benchmark set of metrics. The results have been published in a report which is now available to download [https://www.phuse.eu/kpi-report-phase1-download here].<br>
 +
<br>
 +
'''NEW''': <big>[https://www.phusewiki.org/docs/WorkingGroups/working-group-steering-committee-charter-final-.pdf PhUSE Working Group Charter]</big><br>
 +
Defining the operating guidelines for PhUSE Working Groups members<br>
 +
<br>
 +
'''NEW''':The Nonclinical Topics Working Group would be grateful if you could take a moment to complete this short [https://www.surveymonkey.co.uk/r/FM83BLG survey] on Industry Send Implementation. The outcome of this survey will be presented at the PhUSE 2019 CSS in Silver Spring, June 9-11, then published for public access on the PhUSE [https://www.phusewiki.org/wiki/index.php?title=Industry_SEND_Progress_Survey Wiki] and [https://www.phuse.eu/phuse-references Website].
 +
<br>
 
<br>
 
<br>
'''NEW''' - The Future Forum Project Team have now published their deliverables on 'The Job Description for a Clinical Data Scientist. Follow this [https://www.phuse.eu/phuse-references link] to review<br>
 
 
<br>
 
<br>
Standard Analyses and Code Sharing Working Group has now published Version 2:0 White Paper on Analyses & Displays Associated with Demographics, Disposition, and Medications in Phase 2-4 Clinical Trials and Integrated Summary Document. Click [https://www.phuse.eu/white-papers here] for the revised version under White Papers<br>
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'''ANNOUNCEMENTS'''
 
<br>
 
<br>
PhUSE [http://www.phuse.eu/css-deliverables Standard Operating Procedure] on version control for PhUSE deliverables<br>
 
 
<br>
 
<br>
Optimising the Use of Data Standards Working Group are pleased to announce the publication of the Study Data Standardised Plan, Sponsor Implementationn and relevant Template. Click [https://www.phuse.eu/css-deliverables here] for the deliverables.<br>
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CSS Registration is now open, click [https://www.phuse.eu/css19-registration here] to register.
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<br>
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<br>
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Download the [https://www.phusewiki.org/docs/Website%202019/%2320284%20PhUSE%20Advance%20US%202019%20Flyer%20Jan%202019%20USL%20v7%20(1)%20(1).pdf CSS Flyer] and view the [https://www.phuse.eu/css19-agenda agenda].
 
<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>
 
[http://www.phuse.eu/CSS-deliverables.aspx CS Collaboration Catalog of Deliverables] <br>
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[http://www.phuse.eu/webinars PhUSE Webinars] - Upcoming events and past presentations & recordings<br>
 
[http://www.phuse.eu/webinars PhUSE Webinars] - Upcoming events and past presentations & recordings<br>
 
<br>
 
<br>
Want to become a member of PhUSE? [http://www.phuse.eu/membership Here's how]<br>
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</div>
 +
</div>
 
<br>
 
<br>
 +
<br>
 +
<!-----------------------------Industry News------------------------------>
 +
<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="padding:0.5em 0.5em 0.5em 0.5em;">
 +
GDPR has gone live. Please review '''[[PhUSEWiki:Privacy_policy|PhUSE Privacy Policy]]'''<br>
 +
<br>
 +
The FDA now has a page dedicated to PhUSE on their [https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm482470.htm Website]. It provides an outline how FDA can evaluate and incorporate deliverables into FDA documentation in compliance with GPP<br>
 +
<br>
 +
PhUSE & [https://www.phusewiki.org/wiki/images/6/6a/PhUSE_HL7_SOU_2018_FINAL.pdf HL7 MOU] October 2018 <br>
 +
<br>
 +
FDAs Website now has a page referencing PhUSE and their deliverables which can be found [https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm482470.htm here] <br>
 +
<br>
 +
Here's the [https://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM624623.pdf link] to the latest version of the Technical Conformance Guide ('''TCG''') which has been updated by the FDA January 2019<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>
 +
<br>
 +
PhUSE / CDISC MOU has now been agreed and signed by both parties. Here's the current [http://www.phusewiki.org/wiki/images/6/67/PhUSE_CDISC_MOU_2018_to_2019.pdf version].<br>
 
</div>
 
</div>
 
</div>
 
</div>
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|}
 
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Last revision by {{REVISIONUSER}}, {{REVISIONMONTH}}/{{REVISIONDAY}}/{{REVISIONYEAR}}
 
Last revision by {{REVISIONUSER}}, {{REVISIONMONTH}}/{{REVISIONDAY}}/{{REVISIONYEAR}}

Latest revision as of 09:24, 15 February 2019

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
PhUSE Web Page Wiki.jpg
CS Steering Committee (Wiki).jpg
CSS Working Groups Wiki.jpg
Good Programming Practice Guidance Wiki.jpg

Join a Working Group now!


Currently 6,786 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

CSS 2019 Banner .jpg

Registration Now Open, Call for Posters closes 22nd March

SDE 2018 Standard Banner.jpg

2 SDE's scheduled for March

2019 EU Connect .jpg

Call for Papers Opens 1st March, Registration Opens 1st April

2019 US Connect Website Banner.jpg

Registration still 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 News
  • 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 Group News


Projects calling for Volunteers:

New - Educating for the Future - Data Science
New - Emerging Trends & Technologies - Going Translational with Linked Data
Educating for the Future - Data Engineering
Optimizing the Use of Data Standards - CDISC Implementation Primer
Standard Analyses & Code Sharing - Code Sharing (Repository)


If you are interested in contributing to one of these projects, please email workinggroups@phuse.eu

NEW The KPI Metrics project conducted a survey to test the acceptability of the KPIs and establish an initial benchmark set of metrics. The results have been published in a report which is now available to download here.

NEW: PhUSE Working Group Charter
Defining the operating guidelines for PhUSE Working Groups members

NEW:The Nonclinical Topics Working Group would be grateful if you could take a moment to complete this short survey on Industry Send Implementation. The outcome of this survey will be presented at the PhUSE 2019 CSS in Silver Spring, June 9-11, then published for public access on the PhUSE Wiki and Website.


ANNOUNCEMENTS

CSS Registration is now open, click here to register.

Download the CSS Flyer and view the agenda.

CS Collaboration Catalog of Deliverables

Working Group Quarterly Newsletters

PhUSE Webinars - Upcoming events and past presentations & recordings



Industry News

GDPR has gone live. Please review PhUSE Privacy Policy

The FDA now has a page dedicated to PhUSE on their Website. It provides an outline how FDA can evaluate and incorporate deliverables into FDA documentation in compliance with GPP

PhUSE & HL7 MOU October 2018

FDAs Website now has a page referencing PhUSE and their deliverables which can be found here

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


PhUSE / CDISC MOU has now been agreed and signed by both parties. Here's the current version.



Last revision by WendyDobson, 02/15/2019