Communication of Version Metadata for Open-Source Languages

Project Scope

This project aims to develop a new template or enhance an existing one such as the Study Data Standardization Plan (SDSP) or Analysis Data Reviewer’s Guide (ADRG), to ensure that metadata pertaining to the versions of statistical packages and procedures is consistently documented in alignment with health authority expectations. This standardized template will streamline the submission of clinical study metadata to health authorities as part of the regulatory review process.

Problem Statement

Historically, when using proprietary statistical programming languages, communicating the version metadata of the statistical procedures/functions used to generate analysis has been done within the SAP with a general statement as to the software and version used. With the growing popularity of open-source statistical programming languages, it is no longer necessary to provide metadata on each package as a general statement.

Project Leads	Email
Joel Laxamana	laxamana.joel@gene.com
Lovemore Gakava	lvgk@novonordisk.com
Alex Pearce, PHUSE Project Assistant	alexandra@phuse.global

CURRENT STATUS Q4 2024

Continue FDA Engagement: schedule follow-up discussions with the FDA to gather their feedback on the proposed technical approaches and file format options. Incorporate the agency's input to ensure the new metadata presentation methods meet their requirements.
Finalise Metadata Approach: Based on the internal discussions and FDA feedback, finalise the plan for how to best capture and present the software, environment, and analysis metadata. Decide on the most appropriate location (ADRG, SAP, supplementary document) and format (Quarto/HTML, other) for this information.
Onboard New Team Members: Invite identified participants to join the initiative. Integrate their expertise into the group's efforts to drive the project forward.
Develop Project Plan: Create a detailed project plan outlining the goals, timeline, responsibilities and milestones for this initiative. This will ensure coordinated and efficient execution of the next steps.

Objectives & Deliverables	Timelines
White Paper	Q1 2025

WORKING GROUPS

Communication of Version Metadata for Open-Source Languages

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