Difference between revisions of "PHUSE Wiki"

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'''<big>Bloemfontein - 29th Nov, Durham - 5th Dec, Tokyo - 10th Dec </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:US_Connect_2020.jpg||500x500px|link=https://www.phuse.eu/us-connect20]]<br>
 
 
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'''<big>Registration is open. Hotel selling out fast!</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:CSS_2020_Banner.jpg||500x500px|link=https://www.phuse.eu/css20]]<br>
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[[Image:Virtual_SDE_banner.jpg|500x500px|link=https://www.phuse.eu/sde20]]<br>
 
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'''<big> Save the Date </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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'''ANNOUNCEMENTS'''
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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>
 
 
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'''Final Published Deliverables''' <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>
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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>
 
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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.
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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>
 
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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>
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'''Calling for Volunteers''' <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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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>
 
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'''US Connect''' -  Registration is open, click [https://www.phuse.eu/euconnect19-registration here] for more information
 
 
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'''[[Harmonization_of_SEND_Implementation_to_Enable_Historical_Control_Data_Analysis|Harmonization of SEND Implementation to Enable Historical Control Data Analysis]]'''
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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>
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'''contact workinggroups@phuse.eu to get involved.'''
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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 05:19, 13 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
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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



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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

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Working Groups News




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 Laurenwhite, 07/13/2020