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 6,835 users are helping to Connect, Share, Advance clinical informatics.
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We currently have a deliverables 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.
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.
- 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.
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 WendyDobson, 07/4/2019