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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<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>
 
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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>
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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>
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<!-----------------------------What is this place------------------------------>
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<!-----------------------------Industry News------------------------------>
 
<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;">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;">Industry News</div>
 
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<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 />
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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>
#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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PhUSE & [https://www.phusewiki.org/wiki/images/6/6a/PhUSE_HL7_SOU_2018_FINAL.pdf HL7 MOU] October 2018 <br>
#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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<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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<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 October 2018<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>
 +
*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:SDE_2018_Standard_Banner.jpg|500x500px|link=http://www.phuse.eu/single-day-events-2018]]<br>
[[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]]<br>
 
[[Image:Frankfurt_Connect_Web_Banner.jpg|500x500px|link=http://www.phuse.eu/eu-connect18]]<br>
 
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[[Image:2019_US_Connect_Website_Banner.jpg|500x500px|link=http://www.phuse.eu/us-connect19]]<br>
[[Image:PhUSE_Raleigh_2018_Web_Banner.jpg||500x500px|link=http://www.phuse.eu/us-connect18]]<br>
 
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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>
 
 
<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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Over the last few months the projects within the PhUSE working groups have been incredibly busy working on their deliverables. We currently have four White Papers out for public review. To view the papers and provide your feedback click [https://www.phuse.eu/cs-deliverables-under-review here]. <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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The Optimising the Use of Data Standards Working Group have now published the final cSDRG which includes the Clinical Legacy Data Conversion Plan & Report section. To view the deliverables click [https://www.phuse.eu/css-deliverables here].  
 
<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/CSS-deliverables.aspx CS Collaboration Catalog of Deliverables]''' <br>
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The Test Data Factory project have now released their final document which looks to create CDISC-compliant test datasets focusing on SDTM, ADaM, and SEND. Click [https://www.phuse.eu/phuse-references here] to view the referenced documents.
 
<br>
 
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'''[http://www.phuse.eu/working-groups-quarterly Working Group Quarterly Newsletters]<br>
 
 
<br>
 
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'''[http://www.phuse.eu/webinars PhUSE Webinars] - Upcoming events and past presentations & recordings''''''<br>
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Define XML 2.0 Stylesheet Recommendations have released their final standard document, to view the files click [https://www.phuse.eu/phuse-references here].
 
<br>
 
<br>
'''Want to become a member of PhUSE? [http://www.phuse.eu/membership Here's how]'''<br>
 
 
<br>
 
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The Clinical Trials Data Transparency Toolkit project have released their final White Paper which looks to highlight the evolving global landscape of clinical trial transparency and disclosure. Click [https://www.phuse.eu/white-papers here] to view the paper and the supporting documents.
</div>
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 +
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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>
 +
[http://www.phuse.eu/CSS-deliverables.aspx CS Collaboration Catalog of Deliverables] <br>
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 +
[http://www.phuse.eu/working-groups-quarterly Working Group Quarterly Newsletters]<br>
 
<br>
 
<br>
<!----------------------------------------Industry News------------------------------------------->
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[http://www.phuse.eu/webinars PhUSE Webinars] - Upcoming events and past presentations & recordings<br>
<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;"><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>
 
<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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Want to become a member of PhUSE? [http://www.phuse.eu/membership Here's how]<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>
+
</div>
*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>
+
</div>
*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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Latest revision as of 06:36, 14 December 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 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 6,780 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

GDPR has gone live. Please review PhUSE Privacy Policy and contact the PhUSE Office at office@phuse.eu if you have any queries.

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 October 2018


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


PhUSE Events

SDE 2018 Standard Banner.jpg

Frankfurt Connect Web Banner.jpg

2019 US Connect Website Banner.jpg


Create a new Wiki page

Enter the page title:




Working Group News



Over the last few months the projects within the PhUSE working groups have been incredibly busy working on their deliverables. We currently have four White Papers out for public review. To view the papers and provide your feedback click here.

The Optimising the Use of Data Standards Working Group have now published the final cSDRG which includes the Clinical Legacy Data Conversion Plan & Report section. To view the deliverables click here.

The Test Data Factory project have now released their final document which looks to create CDISC-compliant test datasets focusing on SDTM, ADaM, and SEND. Click here to view the referenced documents.

Define XML 2.0 Stylesheet Recommendations have released their final standard document, to view the files click here.

The Clinical Trials Data Transparency Toolkit project have released their final White Paper which looks to highlight the evolving global landscape of clinical trial transparency and disclosure. Click here to view the paper and the supporting documents.

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 Laurenwhite, 12/14/2018