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    Communication of Version Metadata for Open-Source Languages

      Communication of Version Metadata for Open-Source Languages

      Oct 01, 2025

      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, Gene

      laxamana.joel@gene.com

      Lovemore Gakava, NovoNordisk

      lvgk@novonordisk.com

      Alex Pearce, PHUSE Project Assistant

      alexandra@phuse.global

      CURRENT STATUS (Updated Quarterly) 

      • Made a start on the R package
      • Submitted our feedback to the PHUSE ADRG standard group
      • Presented at the PHUSE CSS 2025 and collated feedback from sponsors and regulatory groups​
      • Draft of ADRG R completion guideline​
      • Draft of ADRG R example​
      • Draft ADRG R package (ADRG quarto template and functions to complete sections of the ADRG)​
      Objectives & DeliverablesTimelines
      White PaperQ1 2025
      , multiple selections available,
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