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>
 
<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/>
 
<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="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>
 
<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>
 
<div style="padding:0.5em 0.5em 0.5em 0.5em;">
 
<div style="padding:0.5em 0.5em 0.5em 0.5em;">
<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>
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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>
</div>
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</div>
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<br>
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<!-----------------------------What is this place------------------------------>
 
<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;">What is this place?</div>
 
<div style="padding:0.5em 0.5em 0.5em 0.5em;">
 
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 />
 
#To support the [[FDA Working Groups|Computational Science Symposium (CSS) Working Groups]] by creating an online collaboration environment.
 
#To support the [[Standard Scripts|sharing]] of statistical and informatics software code (SAS,R etc).
 
#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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</div>
 
</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="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;"><br>
 
<div style="padding:0.5em 0.5em 0.5em 0.5em;"><br>
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[[Image:CSS_2019_Banner_.jpg|500x500px|link=https://www.phuse.eu/css19]]<br>
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'''<big>Registration is open</big>''' <br>
 
<br>
 
<br>
[[Image:Single Day Events 100.jpg|500x500px|link=http://www.phuse.eu/single-day-events-2018]]<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>May Events: London UK, Bejing China, Hyderabad India</big>'''<br>
 
<br>
 
<br>
[[Image:Frankfurt_Connect_Web_Banner.jpg|500x500px|link=http://www.phuse.eu/eu-connect18]]<br>
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[[Image:2019_EU_Connect_.jpg|500x500px|link=https://www.phuse.eu/eu-connect19]]<br>
 
<br>
 
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'''<big> Registration is open, Early Bird closes 26th July</big>'''<br>
 
<br>
 
<br>
[[Image:PhUSE_Raleigh_2018_Web_Banner.jpg||500x500px|link=http://www.phuse.eu/us-connect18]]<br>
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[[image:Florida_Banner.jpg||500x500px|link=https://www.phuse.eu/us-connect20]]<br>
 
<br>
 
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'''<big>Registration & Call for Papers opens 1st July</big>'''<br>
 
<br>
 
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</div>
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</div>
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<br>
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<!--------------------------------Become a PhUSE Member---------------------------------->
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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;">Become a PhUSE Member</div>
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<div style="padding:0.5em 0.5em 0.5em 0.5em;"><br>
 +
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>
 +
*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>
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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>
 
</div>
 
</div>
 
</div>
 
</div>
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<br>
 
<br>
'''NEW''' 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/css-deliverables here] for the revised version under White Papers<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.
 +
<br>
 +
<br>
 +
'''New''': We are pleased to announce that Dhananjay Chhatre known as DJ, will now be working alongside Andy Richardson Co-leading the Emerging Trends and Technologies Working Group. DJ is currently Associate Director at Gilead Sciences and has previously Co-lead the Optimising the Use of Data Standards Working Group. DJ comes with a wealth of knowledge and PhUSE experience.
 +
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<br>
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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>
 +
<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>
 +
<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.
 +
<br>
 +
<br>
 +
'''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. 
 +
<br>
 +
<br>
 +
'''New:''' Data Standards for Non-Interventional Studies project would like to reach out to you again and ask you for your input. We are now trying to get an overview of the challenges you have faced from the perspective of implementation of CDISC standards for non-interventional studies. If you have tried to implement ADaM and/or SDTM for non-interventional studies, please take a few minutes to complete this very short [https://www.surveymonkey.co.uk/r/ZM6JBWK survey]. Your feedback is very much appreciated! <br>
 +
<br>
 +
<br>
 +
If you are interested in contributing to one of our projects, please email '''workinggroups@phuse.eu'''<br>
 +
<br>
 +
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>
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<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>
 
<br>
'''NEW''' - PhUSE [http://www.phuse.eu/css-deliverables Standard Operating Procedure] on version control for PhUSE deliverables<br>
 
 
<br>
 
<br>
'''NEW''' 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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'''ANNOUNCEMENTS'''
 
<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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CSS Registration is now open, click [https://www.phuse.eu/css19-registration here] to register.
 
<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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[http://www.phuse.eu/CSS-deliverables.aspx CS Collaboration Catalog of Deliverables] <br>
 
<br>
 
<br>
'''Want to become a member of PhUSE? [http://www.phuse.eu/membership Here's how]'''<br>
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[http://www.phuse.eu/working-groups-quarterly Working Group Quarterly Newsletters]<br>
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<br>
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[http://www.phuse.eu/webinars PhUSE Webinars] - Upcoming events and past presentations & recordings<br>
 
<br>
 
<br>
 
</div>
 
</div>
 
</div>
 
</div>
 
<br>
 
<br>
<!----------------------------------------Industry News------------------------------------------->
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<br>
<div style="border:1px solid #8898BF">
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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;"><br>
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<div style="padding:0.5em 0.5em 0.5em 0.5em;">
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>
+
GDPR has gone live. Please review '''[[PhUSEWiki:Privacy_policy|PhUSE Privacy Policy]]'''<br>
 +
<br>
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PhUSE Collaborations:<br>
 +
<br>
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[https://www.cdisc.org CDISC]<br>
 +
[https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm482470.htm FDA]<br>
 +
[https://www.hl7.org HL7]<br>
 +
[https://www.psi-cro.com/?gclid=EAIaIQobChMIgbOorLTt4QIV7xXTCh0v9QDJEAAYASAAEgL_lfD_BwE PSI]<br>
 +
[https://www.stardog.com STARDOG]<br>
 +
<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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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>
 
<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>
 
*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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*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>
 
*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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|}
 
|}
 
  
 
----
 
----
 
Last revision by {{REVISIONUSER}}, {{REVISIONMONTH}}/{{REVISIONDAY}}/{{REVISIONYEAR}}
 
Last revision by {{REVISIONUSER}}, {{REVISIONMONTH}}/{{REVISIONDAY}}/{{REVISIONYEAR}}

Latest revision as of 08:38, 20 May 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 6,808 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

May Events: London UK, Bejing China, Hyderabad 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


NewThe 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.

New: We are pleased to announce that Dhananjay Chhatre known as DJ, will now be working alongside Andy Richardson Co-leading the Emerging Trends and Technologies Working Group. DJ is currently Associate Director at Gilead Sciences and has previously Co-lead the Optimising the Use of Data Standards Working Group. DJ comes with a wealth of knowledge and PhUSE experience.


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. 

New: Data Standards for Non-Interventional Studies project would like to reach out to you again and ask you for your input. We are now trying to get an overview of the challenges you have faced from the perspective of implementation of CDISC standards for non-interventional studies. If you have tried to implement ADaM and/or SDTM for non-interventional studies, please take a few minutes to complete this very short survey. Your feedback is very much appreciated!


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

CSS Registration is now open, click here to register.

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 Laurenwhite, 05/20/2019