Difference between revisions of "PHUSE Wiki"

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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 CSS and all the latest news within the industry.
 
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.
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'''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.
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'''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.
  
 
'''DELIVERABLES'''
 
'''DELIVERABLES'''
 
<br>
 
<br>
  
We currently have deliverables out on public review. We encourage you to provide your feedback to the project leads by following the links below:
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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]
 
[https://www.phuse.eu/cs-deliverables-under-review Implement Traceability in CDISC Compliant Studies]
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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.
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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.
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*Integrated SDTM and Integrated ADaM Reviewer’s Guide(s):
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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.  
  
*[[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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*[[Best_Practices_for_Data_Collection_Instructions|Best Practices for Data Collection Instructions]]:
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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.
 
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Revision as of 08:36, 12 July 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
PhUSE Web Page Wiki.jpg
CS Steering Committee (Wiki).jpg
CSS Working Groups Wiki.jpg
Good Programming Practice Guidance Wiki.jpg

Currently 6,837 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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July Events: 18th Hoboken, New Jersey - 27th Bengaluru, India

2019 EU Connect .jpg

Registration is open, Early Bird closes 26th July

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Registration & Call for Papers 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 News
  • 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 Group News


ANNOUNCEMENTS
PhUSE Webinars - Upcoming events and past presentations & recordings

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

EU Connect - With just 20 weeks to go, plans for our event are well underway. Register your place by 26th July to benefit from the discounted Early Bird rate.

US Connect - Registration and Call for Papers are now open for the US Connect 2020, click here for more information.

DELIVERABLES

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:

Implement Traceability in CDISC Compliant Studies

NEW PROJECTS

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.

  • 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.

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.



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 January 2019




Last revision by Laurenwhite, 07/12/2019