Communication of Version Metadata for Open-Source Languages
Project Description |
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This project aims to develop or enhance a standard template (such as the Study Data Standardisation Plan [SDSP] or Analysis Data Reviewer’s Guide [ADRG]) to ensure consistent documentation of metadata related to statistical package versions and procedures. The goal is to align with health authority expectations and streamline the submission of clinical study metadata as part of the regulatory review process. Historically, with proprietary statistical programming languages, version information has typically been captured at a high level within the SAP, often as a general statement of the software and version used. However, with the increasing adoption of open-source technologies, more detailed and transparent metadata is now required. This project will address this gap by enabling structured, standardised capture of package-level metadata, supporting improved traceability, clarity and regulatory confidence. |
Project Leads | |
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Joel Laxamana, Gene | |
Lovemore Gakava, Novaritis | |
Nicola Newton, PHUSE Project Coordinator | nicky@phuse.global |
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