Prepare Materials for the PHUSE/FDA CSS 2025:

Title: Modernizing Documentation Standards for Open-Source Statistical Programming in Clinical Studies - A Work in Progress

Duration: 90 minutes

Target Audience: Clinical study statisticians, regulatory affairs professionals, statistical programmers, and pharmaceutical industry professionals involved in regulatory submissions

Session Overview:

This session presents the ongoing development work by the PHUSE Communication of Version Metadata Working Group to address the evolving needs for documenting statistical programming metadata in clinical trials. With a focus on the transition from proprietary to open-source programming languages, we will share our progress on enhancing the Analysis Data Reviewer's Guide (ADRG) template for open-source clinical trial electronic submissions. The presentation will outline our current collaboration with the FDA, preliminary template designs, and proposed approaches for metadata documentation. We will discuss developing automation strategies for ADRG generation and emerging considerations for hybrid submissions.

Learning Objectives:

• Preview and provide input on the draft ADRG template designed for open-source statistical programming
• Discuss proposed automated approaches for metadata documentation
• Explore preliminary solutions for hybrid submissions using both proprietary and open-source tools
• Participate in shaping industry standards for statistical programming documentation by gathering community feedback.