Difference between revisions of "PHUSE Wiki"

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<div style="background:#D8E8FF; border-bottom:1px solid #8898BF; padding:0.2em 0.5em; font-size:125%; font-weight:bold;"><p style="text-align:center; margin:0px;">Welcome to the PhUSE Wiki</p></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;"><p style="text-align:center; margin:0px;">Welcome to the PHUSE Wiki</p></div>
  
 
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<p style="text-align:center;">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.</p>
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<p style="text-align:center;">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.</p>
  
 
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         <th><big>'''[http://www.phuse.eu PhUSE Website]'''</big></th>
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         <th><big>'''[http://www.phuse.eu PHUSE Website]'''</big></th>
 
         <th><big>'''[[Computational_Science_Working_Group_Steering_Committee|Steering Committee]]'''</big></th>
 
         <th><big>'''[[Computational_Science_Working_Group_Steering_Committee|Steering Committee]]'''</big></th>
 
         <th><big>'''[[CSS Working Groups|Useful Information]]'''</big></th>
 
         <th><big>'''[[CSS Working Groups|Useful Information]]'''</big></th>
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[[Image:PhUSE_Web_Page_Wiki.jpg|center|top|200px||link=http://www.phuse.eu ]]  
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[[Image:Resized_small_logo.png|center|top|200px||link=http://www.phuse.eu ]]  
 
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[[Image:CSS_Working_Groups_Wiki.jpg|center|top|190px|link=CSS Working Groups]]
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[[Image:CSS_Working_Groups_Wiki.jpg|center|top|190px|link=https://www.phusewiki.org/wiki/index.php?title=General]]
 
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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 [[PhUSEWiki:General_disclaimer|Disclaimers]] page
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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 [[PhUSEWiki:General_disclaimer|Disclaimers]] page
  
 
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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><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>
 
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<!--------------------------------PhUSE Events---------------------------------->
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<!--------------------------------PHUSE Events---------------------------------->
 
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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>
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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>
 
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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:PHUSE-FDA_Challenge.jpg|500x500px|link=https://www.phuse.eu/phuse-fda-data-science-innovation-challenge]]<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>
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'''<big>Click [https://www.phuse.eu/phuse-fda-data-science-innovation-challenge here] to listen back and view the presentations</big>''' <br>
 
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[[image:Florida_Banner.jpg||500x500px|link=https://www.phuse.eu/us-connect20]]<br>
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[[Image:Virtual_SDE_banner.jpg|500x500px|link=https://www.phuse.eu/sde20]]<br>
 
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'''<big>Registration & Call for Papers open</big>'''<br>
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'''<big>Gone Virtual. Check website for updates </big>'''<br>
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[[image:EU_Connect_Virtual_2020.jpg||500x500px|link=https://www.phuse-events.org/attend/frontend/reg/thome.csp?pageID=256&eventID=2&traceRedir=2]]<br>
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'''<big>[https://www.phuse-events.org/attend/frontend/reg/tRegisterEmailNew.csp?pageID=332&ef_sel_menu=189&eventID=2&tempPersonID=1246 Registration] now open </big>'''<br>
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[[Image:-23098 PHUSE CSS 2020 Virtual - Banner Standard Size v1.jpg||500x500px|link=https://www.phuse-events.org/attend/frontend/reg/thome.csp?pageID=1068&eventID=3&traceRedir=2]]<br>
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'''<big> [https://www.phuse-events.org/attend/frontend/reg/tRegisterEmailNew.csp?pageID=968&ef_sel_menu=72&eventID=3&tempPersonID=1239 Registration] now open! Early Bird closes 31st July</big>'''<br>
 
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<br>
<!--------------------------------Become a PhUSE Member---------------------------------->
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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;">Become a PhUSE Member</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>
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>
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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>
 
*Free attendance to a range of Single Day Events held across US, EU and Asia<br>
 
*Free attendance to a range of Single Day Events held across US, EU and Asia<br>
*Access to PhUSE News<br>
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*Access to PHUSE Blog <br>
*Full access to PhUSE Archives<br>
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*Full access to PHUSE Archives<br>
 
*Participation in our annual US & EU Connects and the US Computational Science Symposium<br>
 
*Participation in our annual US & EU Connects and the US Computational Science Symposium<br>
 
<br>
 
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<!----------------------------------------News Updates------------------------------------------->
 
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<div style="background:#D8E8FF; border-bottom:1px solid #8898BF; padding:0.2em 0.5em; font-size:125%; font-weight:bold;">Working Group 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;">Working Groups News</div>
 
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'''ANNOUNCEMENTS'''
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'''Deliverables out for public comment''': <br>
 
<br>
 
<br>
[http://www.phuse.eu/webinars PhUSE Webinars] - Upcoming events and past presentations & recordings<br>
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The Analyses and Displays project has produced a White Paper and is currently seeking [https://www.phuse.eu/cs-deliverables-under-review public feedback]. The closing date is '''10th July'''. <br> <br>
Are you a PhUSE member? Login to your account and visit the [https://www.phuse.eu/blog members blog] to find a summary of CSS and all the latest news within the industry.
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The White Paper is intended to provide recommendations on analyses and displays to sponsors who are planning analyses for Safety Topics of Interest for Phase 2-4 Clinical Trials and Integrated Summary documents (or other documents in which analyses of safety are of interest). <br>
 
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<br>
'''DELIVERABLES'''
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<br>
 +
General Output Tips and Considerations project has produced a White Paper and is currently seeking [https://www.phuse.eu/cs-deliverables-under-review public feedback]. The closing date is '''10th July'''. <br> <br>
 +
This White Paper provides general advice on the display of data in tabular form.  The intent is educational and not prescriptive as an aid to considering how to present data in tables.  
 +
<br>
 +
<br>
 +
'''Final Published Deliverables''' <br>
 +
<br>
 +
The Data De-Identification Toolkit project has published a White Paper which draws a detailed dataset(s) anonymisation process map. The paper identifies challenges and potential pitfalls of the process, suggest best practices and offers automation ideas and examples. Click [https://phusewiki.org/docs/WorkingGroups/Deliverables/Data%20Anonymisation%20%26%20Risk%20Assessment%20Automation%20-%20Data%20Transparency.pdf here] to download. <br>
 
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The [https://www.phusewiki.org/docs/WorkingGroups/Deliverables/PHUSE%20DT%20Clinical%20Trial%20Landscape-%20Best%20Practices%20Guide.pdf Global View of the Clinical Transparency Landscape Best Practices Guide] builds upon the “Clinical Trial Transparency and Disclosure: A Global View” White Paper listed below. In this Best Practices Guide, subject matter experts share recommendations with the aim of fostering a holistic approach to clinical data transparency and disclosure that provides accurate and complete information across multiple disclosure platforms. <br>
We currently have a deliverables out on public review. We encourage you to provide your feedback to the project leads by following the links below:
 
 
 
[https://www.phuse.eu/cs-deliverables-under-review Implement Traceability in CDISC Compliant Studies]
 
 
 
'''NEW PROJECTS'''
 
 
<br>
 
<br>
 
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The Clinical Trial Transparency and Disclosure: A Global View White Paper was developed by industry experts with the goal of highlighting the evolving global landscape of clinical trial transparency and disclosure, with special focus on individual study and submission-related requirements. Click [https://www.phusewiki.org/docs/WorkingGroups/Deliverables/PHUSE%20Clinical%20Trial%20Transparency%20and%20Disclosure%20White%20Paper.pdf here] to download the paper. <br>
Projects that would be grateful to receive additional support and input are calling for volunteers. If you are able to dedicate a minimum of one hour per week, please contact workinggroups@phuse.eu to sign up.
 
 
 
*[[Real_World_Evidence|Real World Evidence]]:  
 
This project will look to develop a white paper/presentation focussed on establishing the range of areas that need to be considered/impact on the use of real-world evidence in support of regulated clinical trial submissions.
 
 
 
*[https://www.phusewiki.org/wiki/index.php?title=Open_Source_Technologies_in_Clinical_Research|Open Source Technologies in Clinical Research]: This project will investigate the methods an organisation can use to ensure the thoughtful use of these tools within regulatory environments.
 
 
 
*[[SDSP-XML]]: A follow-on from the DRG-XML, this project will develop a machine-readable version of the Study Data Standardisation Plan as XML.
 
 
<br>
 
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 +
'''Calling for Volunteers''' <br>
 
<br>
 
<br>
 +
'''[[Harmonization_of_SEND_Implementation_to_Enable_Historical_Control_Data_Analysis|Harmonization of SEND Implementation to Enable Historical Control Data Analysis]]'''
 +
The scope of this project is to evaluate and recommend approaches for SEND harmonization to better enable analysis of historical control data. SEND harmonization strategies include creation of new variables, controlled terminology, preferred terms, reference lists and/or analysis strategies (scripts) to enable cross study analysis. Developing a solution framework for variability that includes representation of stakeholders involved in the creation and use of SEND datasets will enable more efficient routine analysis of warehoused SEND data. Harmonizing the implementation and use of SEND is expected to benefit all involved stakeholders and to ultimately contribute to the goal of increased productivity in nonclinical research.<br>
 +
'''contact workinggroups@phuse.eu to get involved.'''
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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>
 
<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;">
 
<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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GDPR has gone live. Please review '''[[PhUSEWiki:Privacy_policy|PHUSE Privacy Policy]]'''<br>
<br>
 
PhUSE Collaborations:<br>
 
<br>
 
[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>
 +
[https://www.phuse.eu/partnerships PHUSE Collaborations]<br>
 
<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>
+
Here's the [https://www.fda.gov/media/136460/download link] to the latest version of the Technical Conformance Guide ('''TCG''') which was updated by the FDA March 2020<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>

Latest revision as of 10:21, 3 July 2020

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
Resized small logo.png
CS Steering Committee (Wiki).jpg
CSS Working Groups Wiki.jpg
Good Programming Practice Guidance Wiki.jpg

Currently 6,861 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



PHUSE-FDA Challenge.jpg


Click here to listen back and view the presentations

Virtual SDE banner.jpg

Gone Virtual. Check website for updates

EU Connect Virtual 2020.jpg

Registration now open

-23098 PHUSE CSS 2020 Virtual - Banner Standard Size v1.jpg

Registration now open! Early Bird closes 31st 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 Blog
  • 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 Groups News


Deliverables out for public comment:


The Analyses and Displays project has produced a White Paper and is currently seeking public feedback. The closing date is 10th July.

The White Paper is intended to provide recommendations on analyses and displays to sponsors who are planning analyses for Safety Topics of Interest for Phase 2-4 Clinical Trials and Integrated Summary documents (or other documents in which analyses of safety are of interest).


General Output Tips and Considerations project has produced a White Paper and is currently seeking public feedback. The closing date is 10th July.

This White Paper provides general advice on the display of data in tabular form. The intent is educational and not prescriptive as an aid to considering how to present data in tables.

Final Published Deliverables

The Data De-Identification Toolkit project has published a White Paper which draws a detailed dataset(s) anonymisation process map. The paper identifies challenges and potential pitfalls of the process, suggest best practices and offers automation ideas and examples. Click here to download.

The Global View of the Clinical Transparency Landscape Best Practices Guide builds upon the “Clinical Trial Transparency and Disclosure: A Global View” White Paper listed below. In this Best Practices Guide, subject matter experts share recommendations with the aim of fostering a holistic approach to clinical data transparency and disclosure that provides accurate and complete information across multiple disclosure platforms.

The Clinical Trial Transparency and Disclosure: A Global View White Paper was developed by industry experts with the goal of highlighting the evolving global landscape of clinical trial transparency and disclosure, with special focus on individual study and submission-related requirements. Click here to download the paper.

Calling for Volunteers

Harmonization of SEND Implementation to Enable Historical Control Data Analysis The scope of this project is to evaluate and recommend approaches for SEND harmonization to better enable analysis of historical control data. SEND harmonization strategies include creation of new variables, controlled terminology, preferred terms, reference lists and/or analysis strategies (scripts) to enable cross study analysis. Developing a solution framework for variability that includes representation of stakeholders involved in the creation and use of SEND datasets will enable more efficient routine analysis of warehoused SEND data. Harmonizing the implementation and use of SEND is expected to benefit all involved stakeholders and to ultimately contribute to the goal of increased productivity in nonclinical research.
contact workinggroups@phuse.eu to get involved.



Industry News

GDPR has gone live. Please review PHUSE Privacy Policy

PHUSE Collaborations

Here's the link to the latest version of the Technical Conformance Guide (TCG) which was updated by the FDA March 2020




Last revision by WendyDobson, 07/3/2020