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.
Currently 6,861 users are helping to Connect, Share, Advance clinical informatics.
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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.
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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:
Implement Traceability in CDISC Compliant Studies
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 firstname.lastname@example.org 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.
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