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="border:1px solid #8898BF">
<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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<br>
[[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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<br>
[[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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<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------------------------------------------->
 
<!----------------------------------------News Updates------------------------------------------->
 
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<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;">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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<br>
 
<br>
'''ANNOUNCEMENTS'''
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'''The Computational Science Symposium 2020 Summary and Prize Winners Blog'''  
 +
<br>
 +
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>
 +
<br>
 +
'''Final Published Deliverables''' <br>
 
<br>
 
<br>
[http://www.phuse.eu/webinars PhUSE Webinars] - Upcoming events and past presentations & recordings<br>
 
  
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 CSS and all the latest news within the industry.
+
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>
 +
<br>
 +
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. 
  
'''EU Connect''' - With just 20 weeks to go, plans for our event are well underway. [https://www.phuse.eu/euconnect19-registration Register] your place by 26th July to benefit from the discounted Early Bird rate.
+
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.  
  
'''US Connect''' - Registration and Call for Papers are now open for the US Connect 2020, click [https://www.phuse.eu/usconnect20-registration here] for more information.  
+
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>
'''DELIVERABLES'''
+
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>
 +
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>
 +
<br>
 +
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>
 
<br>
 
<br>
 
+
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>
We currently have a deliverable 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>
 
+
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>
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.
 
 
 
*[https://www.phusewiki.org/wiki/index.php?title=Integrated_SDTM_and_ADaM_Reviewer%27s_Guide Integrated SDTM and Integrated ADaM Reviewer’s Guide(s)]:
 
The cSDRG and ADRG apply to a single study. Sponsors have used these templates when creating a reviewer’s guide for integrated SDTM and a reviewer’s guide for integrated ADaM data. The template has to be changed in order to document the information for multiple studies.  There is an opportunity to create a template for integrated SDTM and integrated ADaM. The project team will determine if this can be accomplished in one reviewer’s guide or if there should be two separate reviewer’s guides. Deliverables include a template, completion guidelines, and example documents.  
 
 
 
*[[Best_Practices_for_Data_Collection_Instructions|Best Practices for Data Collection Instructions]]:
 
CDISC’s CDASH team provides high level completion instructions related to the core data collection modules. The PhUSE Standard Analysis and Code Sharing Working Group has developed recommended displays (ie, tables and figures) and associated code for use for analysis for data common across therapeutic areas. This project team will network with CDISC and the Standard Analyses and Code Sharing Working Group to ensure alignment.
 
 
<br>
 
<br>
 +
'''Deliverables out for Public Comment''' <br>
 +
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>
 
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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>
+
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 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