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

Project Description:

This project addresses the limitation that cSDRG and ADRG templates are designed for single studies, while sponsors increasingly use them for integrated study data and analysis. It focuses on adapting these templates to effectively capture and document information across multiple studies. 

The project will evaluate whether a single integrated reviewer’s guide or two separate guides (for integrated study data and integrated analysis data) provides the most effective approach. The aim is to ensure clarity, consistency and usability for regulators reviewing integrated submissions. 

Key deliverables include a standardised template, comprehensive completion guidelines, and example documents to demonstrate best practice. These outputs will support sponsors in producing clear, consistent and fit-for-purpose reviewer’s guides for integrated datasets, improving review efficiency and submission quality. 

Regular Project Meeting Day/Time:

• Bi-weekly: Friday 14:00-15:00 GMT

Key Skills:

• • Regulatory Submission Knowledge - Understanding of cSDRG, ADRG, integrated submissions, ISS/ISE concepts, and regulatory reviewer expectations.

  • Clinical Data Standards Expertise - Knowledge of SDTM, ADaM, data integration principles, traceability, and standards used across multiple studies.

  • Technical Writing & Documentation - Ability to develop clear templates, completion guidelines, examples, and best-practice documentation for sponsors.

  • Template Development & Standardisation - Experience creating and maintaining standardised documents and ensuring consistency across regulatory deliverables.

  • Data Integration & Analysis - Understanding how study-level data are pooled and integrated for combined analyses and datasets