Difference between revisions of "PHUSE Wiki"

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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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[[Image:SDE_2019.jpg|500x500px|link=https://www.phuse.eu/single-day-events-2019]]<br>
 
 
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'''<big>Utrecht - 10th Oct, Chennai - 12th Oct, Cincinnati - 24th Oct </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:EU_2019.jpg|500x500px|link=https://www.phuse.eu/eu-connect19]]<br>
 
 
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'''<big> Registration is open </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:US_Connect_2020.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 is 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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'''ANNOUNCEMENTS'''
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'''The Computational Science Symposium 2020 Summary and Prize Winners Blog'''  
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Back in September, the virtual PHUSE/FDA Computational Science Symposium took place, celebrating its 9th year. Click [https://www.phuse.eu/blog/the-computational-science-symposium-2020-summary-and-prize-winners here] to read a summary of the successful event, which includes an overview of the sessions and the all important prize winners.  <br>
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'''Final Published Deliverables''' <br>
 
<br>
 
<br>
We are currently seeking a volunteer to serve as a Co-Lead of the PHUSE Educating for the Future Working Group to work alongside James McDermott. Working Group Co-Leads are critical in providing leadership to the Working Group, supporting the delivery of the active projects and in contributing to the wider efforts of the PHUSE Working Groups. Within the Educating for the Future Working Group, we currently have three projects: an overview of each of these can be found here, together with expected deliverables and timelines.
 
  
Additionally, to perform this role successfully, you will need to be able to commit to attending the monthly Steering Committee meetings and supporting its activities, as well as help contribute to the running of the Computational Science Symposium, which takes place in June in Silver Spring, Maryland, US. Those who are or have previously actively contributed to a PHUSE project are particularly encouraged to apply.
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The PHUSE SDTM/ADaM Implementation FAQ project, created a sub-team to support the Integrated Summary of Safety (ISS) and the Integrated Summary of Efficacy (ISE). This sub-team has produced a White Paper which addresses the frequently asked question for guidance on how to integrate study data for an ISS/ISE. Click [http://phusewiki.org/docs/WorkingGroups/Deliverables/PHUSE%20Integration%20Strategies%20in%20Support%20of%20ISSISE%20Submissions.pdf here] to read the paper. <br>
 
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We ask that all applicants interested in this role provide a brief summary of how you feel you can contribute to driving this Working Group forward. (We suggest about 200 words.)
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The Safety Analytics Working Group held a Workshop at CSS based on Planning and Interpreting Safety Analyses for Integrated Summaries. Click  [https://www.youtube.com/watch?v=E9dYjWeB71k&feature=youtu.be here] to view the recording. 
  
If you would like a more in-depth overview, please contact, in the first instance, James McDermott (james.mcdermott@achieveintelligence.com), our Working Group Co-Lead for Educating for the Future.
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The Safety Analyses Working Group held a Workshop at CSS based on Planning and Interpreting Safety Analyses for Integrated Summaries. Click here to view the recording.  
  
All applications are to be submitted to workinggroups@phuse.eu. Closing date for applications is '''Wednesday 20th November'''.
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The CDISC Implementation Primer project has put together a series of short, animated videos as well as helpful links to introduce newcomers to the suite of CDISC Standards. Click [https://www.cdisc.org/primer here] to explore the standards. <br>
 
<br>
 
<br>
 +
The KPIs & Metrics project has developed upon its year 1 report which developed and published a set of Statistical Programming KPIs to measure the quality and duration of standard operational tasks. The Year 2 part of the project continued this work, concentrating efforts in two major areas: revision and additions to the terminology and definitions, and revising, re-running, and reporting the industry survey. Click [http://phusewiki.org/docs/WorkingGroups/Deliverables/KPIYear2Survey/PHUSE%20KPI%20Metrics%20Report%20Jul%202020.pdf here] to view the Year 2 report.<br>
 +
<br>
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Since non-interventional study data do not necessarily need to be submitted to a regulatory agency, such as the FDA, there is no strict requirement for data standards.The [[Data_Standards_for_Non-Interventional_Studies|Data Standards for Non-interventional Studies]] project has developed a White Paper which looks to identify the most common data standards challenges programmers experience while working on non-interventional studies and to suggest the means to deal with these challenges. Click [http://phusewiki.org/docs/WorkingGroups/Deliverables/Data%20Standards%20for%20Non-interventional_%20Studies.pdf here] to read the paper. <br>
 
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'''Deliverable out for Public Comment''' <br>
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The Optimising the Use of Data Standards – Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Project has published a [http://phusewiki.org/docs/WorkingGroups/Deliverables/PHUSE%20-%20Industry%20Experiences%20Submitting%20Standardized%20Study%20Data%20to%20Regulatory%20Authorities.pdf White Paper]. The paper aims to share submission experiences and develop best practices including submission strategy and planning, regulatory requirements, and interactions with the regulators.<br>
 
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[https://www.phuse.eu/cs-deliverables-under-review Best Practices for Quality Control & Validation]: '''Closing date, 22nd November''' <br>
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PHUSE convened a group of experts from across industry to address the particular challenges Clinical Data Scientists may face in their work. This group has published a [http://phusewiki.org/docs/WorkingGroups/Deliverables/PHUSE%20Clinical%20Data%20Scientists%20Guide%20to%20Studies%20in%20COVID-19%20.pdf White Paper] which offers perspectives from industry experts on what Clinical Data Scientists can expect in studies in COVID-19 and strategies to address some of the challenges they may encounter. This group has also published a series of [https://www.phuse.eu/blog/tag/covid-19%20blogs blogs] providing timely advice as well as an additional [http://phusewiki.org/docs/WorkingGroups/Deliverables/PHUSE%20-%20Clinical%20Data%20Scientist%20Guide%20to%20Studies%20Impacted%20by%20COVID-19.pdf%20White%20Paper White Paper] that considers the impacts of COVID-19 on the collection and analysis of clinical trial data.<br>
 
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[https://www.phuse.eu/webinars-2019 PHUSE Webinars] - Upcoming events and past presentations & recordings<br>
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The SDTM ADaM Implementation FAQ project has published responses to questions submitted on [[SDTM_FAQ_Team_Responses#Topic:_Data_Submissions_.28DSUB_Sub-Team.29|Data Submissions]].<br>
 
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'''Deliverables out for Public Comment''' <br>
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PHUSE Working Groups Projects are soliciting feedback from the broader community on a wide range of deliverables. Click [https://www.phuse.eu/cs-deliverables-under-review here] to review the documents and provide your feedback.<br>
 
<br>
 
<br>
'''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. 
 
  
'''New'''
 
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.
 
 
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>
 
'''New''' The Communications, Promotion & Education Project under the remit of the Standard Analyses & Code Sharing Working Group, have created a Code Repository front end on our [https://education.phuse.eu/coderepository PHUSE Education page]. The vision is to establish and maintain a collaboration platform for leveraging crowd-sourcing to improve the content and implementation of analyses for medical research. Beyond providing important educational material and usage context for the Code Repository, the front end also highlights specific code and data packages for download that are mentioned in [https://www.phuse.eu/white-papers PHUSE final deliverables].
 
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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>
 
<br>
 
'''US Connect''' -  Registration is open, click [https://www.phuse.eu/euconnect19-registration here] for more information
 
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GDPR has gone live. Please review '''[[PhUSEWiki:Privacy_policy|PHUSE Privacy Policy]]'''<br>
 
GDPR has gone live. Please review '''[[PhUSEWiki:Privacy_policy|PHUSE Privacy Policy]]'''<br>
 
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PHUSE Collaborations:<br>
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[https://www.phuse.eu/partnerships PHUSE Collaborations]<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>
 
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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>
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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>
 
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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>
 
*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 12:54, 27 October 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.


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


The Computational Science Symposium 2020 Summary and Prize Winners Blog
Back in September, the virtual PHUSE/FDA Computational Science Symposium took place, celebrating its 9th year. Click here to read a summary of the successful event, which includes an overview of the sessions and the all important prize winners.  

Final Published Deliverables

The PHUSE SDTM/ADaM Implementation FAQ project, created a sub-team to support the Integrated Summary of Safety (ISS) and the Integrated Summary of Efficacy (ISE). This sub-team has produced a White Paper which addresses the frequently asked question for guidance on how to integrate study data for an ISS/ISE. Click here to read the paper. 

The Safety Analytics Working Group held a Workshop at CSS based on Planning and Interpreting Safety Analyses for Integrated Summaries. Click here to view the recording. 

The Safety Analyses Working Group held a Workshop at CSS based on Planning and Interpreting Safety Analyses for Integrated Summaries. Click here to view the recording.

The CDISC Implementation Primer project has put together a series of short, animated videos as well as helpful links to introduce newcomers to the suite of CDISC Standards. Click here to explore the standards. 

The KPIs & Metrics project has developed upon its year 1 report which developed and published a set of Statistical Programming KPIs to measure the quality and duration of standard operational tasks. The Year 2 part of the project continued this work, concentrating efforts in two major areas: revision and additions to the terminology and definitions, and revising, re-running, and reporting the industry survey. Click here to view the Year 2 report.

Since non-interventional study data do not necessarily need to be submitted to a regulatory agency, such as the FDA, there is no strict requirement for data standards.The Data Standards for Non-interventional Studies project has developed a White Paper which looks to identify the most common data standards challenges programmers experience while working on non-interventional studies and to suggest the means to deal with these challenges. Click here to read the paper. 

The Optimising the Use of Data Standards – Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Project has published a White Paper. The paper aims to share submission experiences and develop best practices including submission strategy and planning, regulatory requirements, and interactions with the regulators.

PHUSE convened a group of experts from across industry to address the particular challenges Clinical Data Scientists may face in their work. This group has published a White Paper which offers perspectives from industry experts on what Clinical Data Scientists can expect in studies in COVID-19 and strategies to address some of the challenges they may encounter. This group has also published a series of blogs providing timely advice as well as an additional White Paper that considers the impacts of COVID-19 on the collection and analysis of clinical trial data.

The SDTM ADaM Implementation FAQ project has published responses to questions submitted on Data Submissions.

Deliverables out for Public Comment
PHUSE Working Groups Projects are soliciting feedback from the broader community on a wide range of deliverables. Click here to review the documents and provide your feedback.



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 Laurenwhite, 10/27/2020