Optimizing the Use of Data Standards – Project Volunteer Board

Interested in joining one of the Optimizing the Use of Data Standards Working Group Projects? The projects below welcome new volunteers.

Project Description:

This project was initiated following the Standards Implementation Nuances sessions held at the March 2016 US CSS and the June 2016 EU CSS, which highlighted common challenges faced by SDTM and ADaM implementers and consumers. Discussions also revealed numerous questions relating to data submission requirements across regulatory agencies, including the FDA, PMDA and NMPA, demonstrating the need for a centralised forum and knowledge base. 

The project team collaborates with industry subject matter experts (SMEs), CDISC and regulatory agencies to address these challenges. Its objectives are to collect frequently asked questions from the industry, assess their relevance, and develop clear, consistent responses. Where necessary, the team engages with CDISC and regulatory bodies to ensure accuracy and clarity. 

All validated FAQs and responses are published on the PHUSE website, providing a reliable, accessible resource to support consistent implementation and informed decision-making across the industry. 

Regular Project Meeting Day/Time:

• Bi-weekly: Tuesday 15:00-16:00 GMT

Key Skills:

• CDISC Standards Expertise
  Strong knowledge of CDISC standards, particularly SDTM and ADaM.

• Regulatory Knowledge
  Understanding of regulatory submission requirements (FDA, PMDA, NMPA, etc.).

• Clinical Data Experience
  Experience working with clinical trial data structures, metadata, and implementation guides.

• Guidance Interpretation Skills
  Ability to interpret and apply CDISC guidance, controlled terminology, and best-practice documents