Difference between revisions of "PhUSE Wiki"

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<p style="text-align:center;vertical-align:top;"><big>'''[[Listbox_Instructions|Join a Working Group now!]]'''</big></p>
 
<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>'''''Share, Contribute and 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>'''''Connect, Share, Advance'''''</big> clinical informatics.</p></div><br/>
  
 
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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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<!-----------------------------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;">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;">Industry News</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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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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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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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>
 +
<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>
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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 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>
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[[Image:Single Day Events 100.jpg|500x500px|link=http://www.phuse.eu/single-day-events-2018]]
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[[Image:Single Day Events 100.jpg|500x500px|link=http://www.phuse.eu/single-day-events-2018]]<br>
 
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[[Image:Frankfurt_Connect_Web_Banner.jpg|500x500px|link=http://www.phuse.eu/eu-connect18]]
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[[Image:Frankfurt_Connect_Web_Banner.jpg|500x500px|link=http://www.phuse.eu/eu-connect18]]<br>
 
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[[Image:PhUSE_Raleigh_2018_Web_Banner.jpg||500x500px|link=http://www.phuse.eu/us-connect18]]
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[[Image:PhUSE_Raleigh_2018_Web_Banner.jpg||500x500px|link=http://www.phuse.eu/us-connect18]]<br>
 
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<div style="padding:0.5em 0.5em 0.5em 0.5em;">
 
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'''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''' - 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''' - PhUSE [http://www.phuse.eu/css-deliverables Standard Operating Procedure] on version control for PhUSE deliverables<br>
 
 
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'''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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'''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>
 
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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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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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'''[http://www.phuse.eu/CSS-deliverables.aspx CS Collaboration Catalog of Deliverables]''' <br>
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PhUSE [http://www.phuse.eu/css-deliverables Standard Operating Procedure] on version control for PhUSE deliverables<br>
 
<br>
 
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'''[http://www.phuse.eu/working-groups-quarterly Working Group Quarterly Newsletters]<br>
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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>
'''[http://www.phuse.eu/webinars PhUSE Webinars] - Upcoming events and past presentations & recordings''''''<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>
 
<br>
 
<br>
'''[http://www.phuse.eu/kpi-metricss-project Key Performance Indicators] (KPI)<br>
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[http://www.phuse.eu/CSS-deliverables.aspx CS Collaboration Catalog of Deliverables] <br>
 
<br>
 
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'''[http://www.phuse.eu/future-forum-wgs Future Forum]'''<br>
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[http://www.phuse.eu/working-groups-quarterly Working Group Quarterly Newsletters]<br>
 
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'''[http://www.phuse.eu/data-transparency Data Transparency]'''<br>
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[http://www.phuse.eu/webinars PhUSE Webinars] - Upcoming events and past presentations & recordings<br>
 
<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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Want to become a member of PhUSE? [http://www.phuse.eu/membership Here's how]<br>
 
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<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;">
 
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>
 
<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].
 
 
|}
 
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Revision as of 06:32, 18 May 2018

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 CS Steering Committee CSS Working Groups 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 6,521 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



Industry News

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 March 2018


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


PhUSE Events

Single Day Events 100.jpg

Frankfurt Connect Web Banner.jpg

PhUSE Raleigh 2018 Web Banner.jpg


Create a new Wiki page

Enter the page title:




Working Group News


NEW - Pooling WHOB3 Format White Paper is currently on public review. Should you wish to review and comment, click here

NEW - The Future Forum Project Team have now published their deliverables on 'The Job Description for a Clinical Data Scientist. Follow this link to review

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 here for the revised version under White Papers

PhUSE Standard Operating Procedure on version control for PhUSE deliverables

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 here for the deliverables.

Calling all volunteers. Are you interested in joining one of the new projects recently approved by the CS Steering Committee?. This link will take you to an overview of the latest projects looking for members.

CS Collaboration Catalog of Deliverables

Working Group Quarterly Newsletters

PhUSE Webinars - Upcoming events and past presentations & recordings

Want to become a member of PhUSE? Here's how




Last revision by WendyDobson, 05/18/2018