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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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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[[Image:SDE_2019.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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'''<big>Bloemfontein - 29th Nov, Durham - 5th Dec, Tokyo - 10th Dec </big>'''<br>
 
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<br>
[[Image:2019_EU_Connect_.jpg|500x500px|link=https://www.phuse.eu/eu-connect19]]<br>
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[[image:US_Connect_2020.jpg||500x500px|link=https://www.phuse.eu/us-connect20]]<br>
 
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<br>
'''<big> Registration is open, Early Bird closes 26th July</big>'''<br>
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'''<big>Registration is open. Hotel selling out fast!</big>'''<br>
 
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<br>
[[image:Florida_Banner.jpg||500x500px|link=https://www.phuse.eu/us-connect20]]<br>
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[[Image:CSS_2020_Banner.jpg||500x500px|link=https://www.phuse.eu/css20]]<br>
 
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'''<big>Registration & Call for Papers open</big>'''<br>
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'''<big> Save the Date </big>'''<br>
 
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</div>
 
</div>
 
</div>
 
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<!--------------------------------Become a PhUSE Member---------------------------------->
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<!--------------------------------Become a PHUSE Member---------------------------------->
 
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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="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>
 
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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>
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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>
 
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<!----------------------------------------News Updates------------------------------------------->
 
<!----------------------------------------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'''
 
'''ANNOUNCEMENTS'''
 
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<br>
[http://www.phuse.eu/webinars PhUSE Webinars] - Upcoming events and past presentations & recordings<br>
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We are pleased to announce a new Co-Lead for the [[Educating_For_The_Future|Educating for the Future Working Group]] to work alongside James McDermott. Greg Silva, is a director of Statistical Programming at AstraZeneca and has a background in computer science. Greg is hoping to build career paths based on education and grow the next generation of Data Scientists and strategic thinkers <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.
+
<br>
 
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'''NEW''' The SEND Dataset QC Best Practices project is looking to develop recommendations for stakeholders for efficient and effective SEND QC practices. In order to explore the variety of QC procedures and tools among different stakeholders the team are asking members to participate in this short [https://www.surveymonkey.co.uk/r/KQW6DK8 survey]. This survey will close by the end of November. <br>
'''DELIVERABLES'''
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The [https://www.phuse.eu/kpi-metrics-definitions-terminology-map PHUSE Key Performance Indicators & Metrics Project] has established a set of common data reporting metrics which are more detailed than industry-wide metrics, therefore allowing a greater level of granularity in our project reporting, and business process management.
 +
<br>
 +
These metrics and their definitions are issued annually as a survey to life sciences industry companies in order to collect their information. The Year 2 survey is now being distributed to collate information from 20+ companies. Should you wish your company to participate, contact workingroups@phuse.eu.<br>
 +
<br>
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[https://www.phuse.eu/webinars-2019 PHUSE Webinars] - Upcoming events and past presentations & recordings<br>
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'''Deliverables''' <br>
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'''NEW''' The Best Practice for Submission of Event Adjudication Data has released a White Paper mapping out the common practices and challenges for submissions of event adjudication data. Click [https://www.phusewiki.org/docs/WorkingGroups/Deliverables/Best%20Practices%20for%20Submission%20of%20EA%20Data%20A4.pdf here] to download the paper.  
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'''NEW''' The Data Reviewer's Guide in XML project from the Optimising the Use of Data Standards Working Group have released v2.0 of the Prototype Package. This prototype release v2.0 package looks to provide a more stable version for industry early adoption and testing for a future final publication that encompasses all DRGs. Click [https://www.phusewiki.org/docs/WorkingGroups/Deliverables/DRG-XML%20V2.0/PHUSE%20DRG-XML%20Prototype%20Package%20Release%20v2.0%202.zip here] to download the full package. <br>
 
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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'''
 
 
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Are you a PHUSE member? Log in to your account and visit the [https://www.phuse.eu/blog members blog] to find a summary of all the latest news within the industry.<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.
 
 
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'''US Connect''' -  Registration is open, click [https://www.phuse.eu/euconnect19-registration here] for more information
 
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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>
 
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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>
 
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<br>
PhUSE Collaborations:<br>
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PHUSE Collaborations:<br>
 
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[https://www.cdisc.org CDISC]<br>
 
[https://www.cdisc.org CDISC]<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>
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Here's the [https://www.fda.gov/media/131872/download link] to the latest version of the Technical Conformance Guide ('''TCG''') which has been updated by the FDA October 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>

Latest revision as of 05:54, 2 December 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
Resized small logo.png
CS Steering Committee (Wiki).jpg
CSS Working Groups Wiki.jpg
Good Programming Practice Guidance Wiki.jpg

Currently 6,840 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


SDE 2019.jpg

Bloemfontein - 29th Nov, Durham - 5th Dec, Tokyo - 10th Dec

US Connect 2020.jpg

Registration is open. Hotel selling out fast!

CSS 2020 Banner.jpg

Save the Date


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


ANNOUNCEMENTS
We are pleased to announce a new Co-Lead for the Educating for the Future Working Group to work alongside James McDermott. Greg Silva, is a director of Statistical Programming at AstraZeneca and has a background in computer science. Greg is hoping to build career paths based on education and grow the next generation of Data Scientists and strategic thinkers


NEW The SEND Dataset QC Best Practices project is looking to develop recommendations for stakeholders for efficient and effective SEND QC practices. In order to explore the variety of QC procedures and tools among different stakeholders the team are asking members to participate in this short survey. This survey will close by the end of November. 


The PHUSE Key Performance Indicators & Metrics Project has established a set of common data reporting metrics which are more detailed than industry-wide metrics, therefore allowing a greater level of granularity in our project reporting, and business process management.
These metrics and their definitions are issued annually as a survey to life sciences industry companies in order to collect their information. The Year 2 survey is now being distributed to collate information from 20+ companies. Should you wish your company to participate, contact workingroups@phuse.eu.

PHUSE Webinars - Upcoming events and past presentations & recordings

Deliverables


NEW The Best Practice for Submission of Event Adjudication Data has released a White Paper mapping out the common practices and challenges for submissions of event adjudication data. Click here to download the paper.
NEW The Data Reviewer's Guide in XML project from the Optimising the Use of Data Standards Working Group have released v2.0 of the Prototype Package. This prototype release v2.0 package looks to provide a more stable version for industry early adoption and testing for a future final publication that encompasses all DRGs. Click here to download the full package. 


Are you a PHUSE member? Log in to your account and visit the members blog to find a summary of all the latest news within the industry.

US Connect - Registration is open, click here for more information



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 October 2019




Last revision by Laurenwhite, 12/2/2019