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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<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/>
 
<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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<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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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 is open</big>''' <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>July Events: 18th Hoboken, New Jersey - 27th Bengaluru, India</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> Registration is open, Early Bird closes 26th July</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:Florida_Banner.jpg||500x500px|link=https://www.phuse.eu/us-connect20]]<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 & Call for Papers opens 1st July</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].
 
 
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</div>
 
</div>
 
</div>
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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>
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*Access to PhUSE News<br>
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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>
 
<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>
 
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'''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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'''New''' The detailed agenda for the upcoming CSS is now available to download. Click [https://www.phuse.eu/css19-agenda here] to view the agenda and plan the sessions you would like to attend.
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'''Information''' On June 12, 2019, Health Policy at Duke University will convene a public workshop to consider key implementation challenges and potential opportunities to advance the development and application of analysis data standards. To register for the conference which is working in cooperation with the FDA follow this [https://healthpolicy.duke.edu/events/advancing-development-and-implementation-analysis-data-standards-key-challenges-and link].
 
<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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'''Information''': Effective 30th April, our distribution list forum Listbox will no longer be active. PhUSE office will manage communications so please send content to workinggroups@phuse.eu for distribution on your behalf.
 
<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>
 
 
<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>
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'''New''': The Standard Analyses and Code Sharing Working Group are calling for volunteers to participate in the [[Good_Programming_Practice_in_Macro_Development|Good Programming Practice in Macro Development]] Project. The team looking to develop a Guideline / White Paper for creating well-structured and precisely documented macro code that will be easy to read and maintain over time.
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'''New''': The PhUSE Optimizing the Use of Data Standards Working Group has published a White Paper on Best Practices for Documenting Dataset Metadata: Define-XML Versus Reviewer’s Guide. Click [https://www.phusewiki.org/docs/Deliverables/Best%20Practices%20for%20Documenting%20%20Dataset%20Metadata%20-%20Define-XML%20versus%20%20Reviewers%20Guide%20-%2005APR2019.pdf here] to view the paper. 
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If you are interested in contributing to one of our projects, please email '''workinggroups@phuse.eu'''<br>
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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>
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<big>[https://www.phusewiki.org/docs/WorkingGroups/working-group-steering-committee-charter-final-.pdf PhUSE Working Group Charter]</big><br>
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Defining the operating guidelines for PhUSE Working Groups members<br>
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'''ANNOUNCEMENTS'''
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[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>
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</div>
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<br>
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<br>
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<!-----------------------------Industry News------------------------------>
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<div style="border:1px solid #8898BF;">
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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>
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<div style="padding:0.5em 0.5em 0.5em 0.5em;">
 +
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>
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[https://www.stardog.com STARDOG]<br>
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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>
 
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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 09:25, 4 June 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

Currently 6,813 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 is open

SDE 2018 Standard Banner.jpg

July Events: 18th Hoboken, New Jersey - 27th Bengaluru, India

2019 EU Connect .jpg

Registration is open, Early Bird closes 26th July

Florida Banner.jpg

Registration & Call for Papers opens 1st 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 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


New The detailed agenda for the upcoming CSS is now available to download. Click here to view the agenda and plan the sessions you would like to attend.

Information On June 12, 2019, Health Policy at Duke University will convene a public workshop to consider key implementation challenges and potential opportunities to advance the development and application of analysis data standards. To register for the conference which is working in cooperation with the FDA follow this link.

Information: Effective 30th April, our distribution list forum Listbox will no longer be active. PhUSE office will manage communications so please send content to workinggroups@phuse.eu for distribution on your behalf.


New: The Standard Analyses and Code Sharing Working Group are calling for volunteers to participate in the Good Programming Practice in Macro Development Project. The team looking to develop a Guideline / White Paper for creating well-structured and precisely documented macro code that will be easy to read and maintain over time.

New: The PhUSE Optimizing the Use of Data Standards Working Group has published a White Paper on Best Practices for Documenting Dataset Metadata: Define-XML Versus Reviewer’s Guide. Click here to view the paper. 


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

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.

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


ANNOUNCEMENTS

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

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 January 2019




Last revision by WendyDobson, 06/4/2019