Page History

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:

1. Collect frequently asked questions (FAQs) from Industry via a form on Wiki and PHUSE public events

2. Assess the appropriateness of a question, develop & review a response, collaborate with CDISC/FDA for clarity if required

3. Publish the FAQ and responses on the Wiki database for helpful implementation/strategy information