Difference between revisions of "CSS Working Groups"

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=Instructions=
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[[Image:Working_Groups_Banner_Website.jpg|center|top|1000px|link=http://www.phusewiki.org/wiki/images/f/fe/Working_Groups_Banner_Website.jpg]]
This wiki is available to document the progress of the FDA/PhUSE Computational Science Symposium working groups and projects.  The wiki enables quick,easy and transparent online collaboration.  Working groups each have a main page which is the starting page for all Working Group activity.  <br />
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__NOTOC__
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=Overview=
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This wiki is available to document the progress of the PHUSE Working Groups and Projects.  The wiki enables quick, easy and transparent online collaboration.  Working Groups each have a main page which is the starting page for all Working Group activity.  <br />
  
If you are new to wikis you might want to '''[[Help|check out the help section]]'''. To get started click on your working group below.
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If you are new to wikis you might want to '''[[Help|check out the help section]]'''. To get started click on your Working Group on the left hand side bar.
 
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For instructions on how to subscribe to the working group/project email list or contact a working goup leadership team  '''[[Listbox Instructions|click here]]'''
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For instructions on how to subscribe to the Working Group/Project email wendy@phuse.eu
 
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<br />
=FDA/PhUSE Working Groups=
 
<big> '''[[:Category:ActiveProject|Currently active projects for all Working Groups can be found here]]''' </big>
 
 
 
<big>'''[[Data_Validation_and_Quality_Assessment|Improving Data Quality]]''' </big>
 
This working group will focus on collaborating to develop a robust process to rapidly validate and assess data quality as data moves through product lift cycle across both industry and regulatory review. The group will discuss current pains and potential solutions regarding topics such as current data validation rules, therapeutic specific data issues and improving the quality of the data to support specific analytical needs.
 
 
 
<big>'''[[Optimizing the Use of Data Standards]]'''</big>
 
The development and adoption of data standards over the last decade has shown significant promise in improving efficiencies in the product submission and review process. However, there have also been gaps, issues and challenges in the interpretation and use of the standards. This group will identify specific gaps preventing FDA and industry from optimizing the use of standards and collaborate to close those gaps.
 
 
 
<big>'''[[Standard_Scripts|Development of Standard Scripts for Analysis and Programming]]''' </big>
 
With the development and implementation of industry data standards, there is a great opportunity to develop standard reporting across industry and to support the needs of FDA medical and statistical reviewers. This working group will identify potential standard scripts for data transformations and analyses across an within therapeutic areas. The goal will be to begin the process of standardizing analyses across the industry, but also include examples of what can be done with a standardized data set.
 
 
 
<big>'''[[Non-Clinical_Road-map_and_Impacts_on_Implementation|Non-Clinical Road-map and Impacts on Implementation]]'''</big>
 
There is a need to improve nonclinical assessment and regulatory science by identifying key needs and challenges in the field and then establish an innovative framework for addressing them in a collaborative manner. The group created a framework for moving certain projects forward to support nonclinical informatics efforts and to develop specific implementation solutions and SEND.
 
  
<big>'''[[Emerging_Technologies|Emerging Technologies]]'''</big>
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The Working Groups are governed by the '''[[Computational_Science_Working_Group_Steering_Committee| Steering Committee]]''' which provides oversight to the Working Groups.
This emerging technologies working group will be an open, transparent forum for sharing  pre-competitive means of applying new technologies and is being challenged with creation of well-defined collaborative projects that will describe, prioritize, assess, and assist advancement of these opportunities.  Possible topics include (but are not limited to) semantic web applications, analysis metadata, modeling, simulation, and “The Cloud”.
 
  
=FDA/PhUSE 2012 Archived Working Groups=
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=Working Groups & Projects Overview=
[[Image:Csc.jpg|250x250px|right|link= |caption]]
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{| class="wikitable" style=width:100%
'''[[Data Validation and Quality Assessment]]'''
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|-
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''With so many active projects within PHUSE, now is a great time to get involved. If you are interested in joining a project, please contact workinggroups@phuse.eu''<br>
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<br>
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|'''[[Data_Transparency|Data Transparency]]''' || '''[[Educating_For_The_Future|Educating for the Future]]''' || '''[[Emerging_Technologies|Emerging Trends & Technologies]]''' || '''[[Nonclinical_Topics_Working_Group|Nonclinical Topics]]''' || '''[[Optimizing_the_Use_of_Data_Standards|Optimizing the Use of Data Standards]]''' || '''[https://www.phusewiki.org/wiki/index.php?title=Standard_Analyses_%26_Code_Sharing Standard Analyses & Code Sharing]'''
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|-
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| [[Clinical_Trials_Data_Transparency_Toolkit|Clinical Trials Toolkit]] || [[Data_Engineering|Data Engineering]] || [[Blockchain_Technology|Blockchain]] ''' || [[Data_Consistency:_SEND_Datasets_and_the_Study_Report|SEND Datasets]] || [[Best_Practices_for_Data_Collection_Instructions|Best Practices for Data Collection]] || [[WG5_Project_08|Analyses & Displays White Paper]]s
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|-
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|[[PhUSE_De-Identification_Standards|De-identification Standards]] || [[Design_Thinking|Design Thinking]] || [[Cloud_Adoption_in_the_Life_Sciences_Industry|Cloud Adoption]] || [[Demystifying_Define-XML_Codelist_Handling_for_Nonclinical_Studies|Demystifying Define-XML]] ||  || [[Code_Sharing_(Repository)|Code Sharing (Repository)]]
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|-
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|[[GDPR_Impact_on_Data_Collection_Practices|GDPR Impact]] || [[Data_Science|Data Science]] || [[Investigating_the_use_of_FHIR_in_Clinical_Research|FHIR]] || [[Modeling_Endpoints:_How_to_Model_Anti-Drug_Antibody_Data_in_Nonclinical_Studies|ADA Endpoints]] || [[Data_Reviewer%27s_Guide_in_XML|DRG in XML]] || [[WG5_Project_07|Communications, Promotion & Education]]
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|-
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|[[Policy,_Guidance_and_Material_Reviews|Policy, Guidance & Materials]] || ||  [https://www.phusewiki.org/wiki/index.php?title=Key_Performance_Indicators_%26_Metrics_(KPI) KPI Summary] || [[Nonclinical_Script_Assessment_Project|Script Assessment]] ||  [https://www.phusewiki.org/wiki/index.php?title=Integrated_SDTM_and_ADaM_Reviewer%27s_Guide#Project_Overview Integrated SDTM and ADaM Reviewer's Guide] || [[WG5_Project_09|Test Data Factory]]
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|-
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|[[Policy_0070_Interpretations|EMEA Policy 0070]] || || [https://www.phusewiki.org/wiki/index.php?title=Going_Translational_with_Linked_Data_(GoTWiLD) Going Translational with Linked Data] || [[Nonclinical_Study_Data_Reviewers_Guide|Nonclinical SDRG]] ||  || [[Good_Programming_Practice_in_Macro_Development|Good Programming Practice]]
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|-
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|[[Data_De-identification_Toolkit|Data De-identification Toolkit]] || || [[Data_Visualisations_for_Clinical_Data|Data Visualisation]] ''' || [[SEND_Implementation_User_Group|SEND Implementation]] || [[Data_Standards_for_Non-Interventional_Studies|Data Standards for Non-Interventional Studies]] || [[Best_Practices_for_Quality_Control_and_Validation|Best Practices for Quality Control & Validation]]
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|-
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| || || [[Machine_Learning_/_Artificial_Intelligence|Machine Learning & Artificial Intelligence]] ''' || [[Data_Visualisation_as_an_Enabler_for_Nonclinical_Safety_Signal_Detection|Safety Signal Detection]] || [[CDISC_Implementation_Primer|CDISC Implementation Primer]] ''' ||
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|-
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| || || [[Open_Source_Technologies_in_Clinical_Research|Open Source Technologies in Clinical Research]] || [[Industry_SEND_Progress_Survey|SEND Progress Survey]] || [[SDTM_ADaM_Implementation_FAQ|SDTM Implementation FAQ]] ''' ||
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|-
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|| || || [[Real_World_Evidence|Real World Evidence]] ||[[SEND_Dataset_QC_Best_Practices|SEND Dataset QC Best Practices]] || [[Industry_Experiences_Submitting_Standardised_Study_Data_to_Regulatory_Authorities|Submitting Study Data to Regulatory Authorities]]  ||
  
'''[[Standardizing data within the Inspection Site Selection Process]]'''
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|}
  
'''[[Challenges of Integrating and Converting Data across Studies]]'''
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=Useful Information for Projects=
 
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<BR>
'''[[Standards Implementation Issues with the CDISC Data Models]]'''
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{| class="wikitable"
 
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| '''Topic''' || '''Overview''' || '''Useful Links'''
'''[[Development of Standard Scripts for Analysis and Programming]]'''
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|-
 
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| '''NEW:''' Welcome Pack || Want a detailed overview of our Working Groups and Projects? Want to know how to get involved? Hints and Tips for using Teamwork and the Wiki? Then this Welcome Pack is the place to go. It provides useful information for new projects and the on boarding of new project members. What support the PHUSE office provides as well as some useful links to help the projects progress || [https://www.phuse.eu/working-groups Link]
'''[[Non-Clinical Road-map and Impacts on Implementation]]'''
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=Working Group Oversight=
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|Working Groups Charter || Defining the operating guidelines for PHUSE Working Group members || [https://www.phusewiki.org/wiki/images/8/80/Working_Group_Steering_Committee_Charter_Final_Jan_2019.docx Charter]
Below is a list of Working Group and Project oversight information.
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| Teamwork || Teamwork is the collaboration tool used for our Projects and is available to project members. Once you have joined a project, you'll be granted access and once you've set up your account, you can then review the materials the projects produce || [https://www.teamwork.com/ Teamwork]
[[CSS Project Template|CSS New Project Wiki Template Page]]
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|-
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|Process Map || PHUSE Standard Operating Procedure for Version Control of PHUSE Deliverables. Each project will produce a deliverable in some form, this flow chart and process will assist you in seeking approval for public review and ultimately finalisation. If you have any queries, please reach out to your Working Group Lead or Wendy@phuse.eu.<br> || [http://www.phusewiki.org/wiki/images/b/ba/WP001-SC_Deliverable_Review_Process_Map_%28Final%29.pdf flow diagram]
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|-
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|Working Practices|| Step by Step guide||[http://www.phusewiki.org/wiki/images/c/ca/WP001-SC_Deliverable_Review_%28Final%29.pdf Working Practice Procedure]
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|-
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|New Project Requests || Do you have an idea for a PHUSE Project? Then complete this New Project Request Template and send to wendy@phuse.eu || [http://www.phusewiki.org/wiki/images/1/18/New_Project_Requests.docx New Project Request]
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|-
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|Giving a '''PHUSE Project''' presentation || Working Groups Powerpoint Presentation Template || [https://www.phusewiki.org/wiki/images/6/68/PhUSE_Working_Groups_PP_Jan_2019_.pptx Link]
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|Giving a PHUSE Presentation || Presenting at one of our conferences? This is the standard PHUSE Powerpoint Template || [https://www.phusewiki.org/wiki/images/8/8f/PhUSE_Generic_Slide_Template.pptx Link]
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|-
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|White Papers Template || Is your projects deliverable a White Paper? PHUSE has produced a White Paper Template to assist in the creation ||  [https://www.phusewiki.org/wiki/images/4/40/Deliverables_Template_Sept_2019.docx Link]
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|-
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| PHUSE Deliverables || All of the final PHUSE projects deliverables can be found on the PHUSE Website || [http://www.phuse.eu/CSS-deliverables.aspx CS Catalog of Deliverables on www.phuse.eu]
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|-
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| Creating a Wiki Page || The link will send you to a template for creating a new Wiki page. You can highlight the content and paste into your new page || [[CSS_Project_Template|link]]
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|Want to volunteer? || We have new projects that are looking for volunteers. If you would like to join one of these projects, please contact Wendy@phuse.eu || [https://www.phuse.eu/cs-new-project-ideas Call for Volunteers]
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|Webinar Wednesday || To view the agenda and register for the upcoming Webinar Wednesday visit the PHUSE Website || [https://www.phuse.eu/webinars Webinar Wednesday Registration]
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|-
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|Key Conference Dates || Planning a deliverable for one of the PHUSE conferences? Want to know when registration closes? Visit the PHUSE website || [https://www.phuse.eu/conferences Conferences]
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|-
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|}
  
 
=Disclaimer=
 
=Disclaimer=

Latest revision as of 08:15, 10 October 2019

Working Groups Banner Website.jpg

Overview

This wiki is available to document the progress of the PHUSE Working Groups and Projects. The wiki enables quick, easy and transparent online collaboration. Working Groups each have a main page which is the starting page for all Working Group activity.

If you are new to wikis you might want to check out the help section. To get started click on your Working Group on the left hand side bar.

For instructions on how to subscribe to the Working Group/Project email wendy@phuse.eu

The Working Groups are governed by the Steering Committee which provides oversight to the Working Groups.

Working Groups & Projects Overview

With so many active projects within PHUSE, now is a great time to get involved. If you are interested in joining a project, please contact workinggroups@phuse.eu

Data Transparency Educating for the Future Emerging Trends & Technologies Nonclinical Topics Optimizing the Use of Data Standards Standard Analyses & Code Sharing
Clinical Trials Toolkit Data Engineering Blockchain SEND Datasets Best Practices for Data Collection Analyses & Displays White Papers
De-identification Standards Design Thinking Cloud Adoption Demystifying Define-XML Code Sharing (Repository)
GDPR Impact Data Science FHIR ADA Endpoints DRG in XML Communications, Promotion & Education
Policy, Guidance & Materials KPI Summary Script Assessment Integrated SDTM and ADaM Reviewer's Guide Test Data Factory
EMEA Policy 0070 Going Translational with Linked Data Nonclinical SDRG Good Programming Practice
Data De-identification Toolkit Data Visualisation SEND Implementation Data Standards for Non-Interventional Studies Best Practices for Quality Control & Validation
Machine Learning & Artificial Intelligence Safety Signal Detection CDISC Implementation Primer
Open Source Technologies in Clinical Research SEND Progress Survey SDTM Implementation FAQ
Real World Evidence SEND Dataset QC Best Practices Submitting Study Data to Regulatory Authorities

Useful Information for Projects


Topic Overview Useful Links
NEW: Welcome Pack Want a detailed overview of our Working Groups and Projects? Want to know how to get involved? Hints and Tips for using Teamwork and the Wiki? Then this Welcome Pack is the place to go. It provides useful information for new projects and the on boarding of new project members. What support the PHUSE office provides as well as some useful links to help the projects progress Link
Working Groups Charter Defining the operating guidelines for PHUSE Working Group members Charter
Teamwork Teamwork is the collaboration tool used for our Projects and is available to project members. Once you have joined a project, you'll be granted access and once you've set up your account, you can then review the materials the projects produce Teamwork
Process Map PHUSE Standard Operating Procedure for Version Control of PHUSE Deliverables. Each project will produce a deliverable in some form, this flow chart and process will assist you in seeking approval for public review and ultimately finalisation. If you have any queries, please reach out to your Working Group Lead or Wendy@phuse.eu.
flow diagram
Working Practices Step by Step guide Working Practice Procedure
New Project Requests Do you have an idea for a PHUSE Project? Then complete this New Project Request Template and send to wendy@phuse.eu New Project Request
Giving a PHUSE Project presentation Working Groups Powerpoint Presentation Template Link
Giving a PHUSE Presentation Presenting at one of our conferences? This is the standard PHUSE Powerpoint Template Link
White Papers Template Is your projects deliverable a White Paper? PHUSE has produced a White Paper Template to assist in the creation Link
PHUSE Deliverables All of the final PHUSE projects deliverables can be found on the PHUSE Website CS Catalog of Deliverables on www.phuse.eu
Creating a Wiki Page The link will send you to a template for creating a new Wiki page. You can highlight the content and paste into your new page link
Want to volunteer? We have new projects that are looking for volunteers. If you would like to join one of these projects, please contact Wendy@phuse.eu Call for Volunteers
Webinar Wednesday To view the agenda and register for the upcoming Webinar Wednesday visit the PHUSE Website Webinar Wednesday Registration
Key Conference Dates Planning a deliverable for one of the PHUSE conferences? Want to know when registration closes? Visit the PHUSE website Conferences

Disclaimer

FDA comments are an informal communication and represent the individual's best judgment. These comments do not bind or obligate FDA. The contents of this wiki are from the individual contributors and do not necessarily reflect the view and/or policies of the Food and Drug Administration, the employers of the individuals involved or any of their staff.