Optimizing the Use of Data Standards – Project Volunteer Board

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

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, NMPA). 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. If you have a question for the team, email workinggroups@phuse.global.

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 Advance Hub database for helpful implementation/strategy information.

Regular Project Meeting Day/Time:

• Bi-weekly: Tuesday 15:00-16:00 BST

Key Skills: (currently being reviewed by WG Leads)

Project Kick Off Meeting:

• 28 July 2025 at

Key Skills:

• Programmers/Programming Managers
  Experience with SDTM, ADaM, Define.xml, or custom study builds; comfort with JSON, Excel metadata, and study design workflows is a plus.

• Data Managers and Study Builders
  First-hand experience with the operational standards embedded in EDCs and other systems—edit checks, functions, templates; experience handling CRF and External data.

• Standards Governance SMEs
  Involved in defining and maintaining enterprise standards, terminology libraries, or therapeutic area-specific metadata frameworks.

• Software Developers and Integration Architects
  Skilled in building, connecting, or automating; interest in version control, push-pull protocols, and APIs.

• IT & Infrastructure Stakeholders (IT R&D Managers);
  Those who support metadata environments, address access controls, audit trails, system