Skip to end of metadata
Go to start of metadata
You are viewing an old version of this page. View the current version.
Compare with Current
View Page History
« Previous
Version 90
Next »
Project Scope |
The Standards Implementation Nuances sessions at the March North America 2016 CSS and June EU 2016 CSS surfaced various common challenges amongst SDTM and ADaM implementers and consumers. In addition, there were many questions discussed related to data submissions requirements by various regulatory agencies around the world (e.g. FDA, PMDA, China FDA). It became very clear that the Industry is in need of a forum and subsequent knowledge-base (FAQ) to address these challenges. This project team was formed in June 2016 to collaborate with Subject Matter Experts (SMEs) from the industry, CDISC, and the FDA. The goal of this project team is to: Collect frequently asked questions (FAQs) from Industry. If you have a question for the team, email workinggroups@phuse.global. Assess the appropriateness of a question, develop & review a response, collaborate with CDISC/FDA for clarity if required. Publish the FAQ and responses on Advance Hub database for helpful implementation/strategy information.
|
|
---|
Continuing to receive and answer questions. Responses are published to the PHUSE Advance Hub. |
Objectives & Deliverables | Timelines |
---|
Publish responses to questions received under: | Ongoing |