Welcome to the PHUSE Open-Source Metadata Documentation Working Group Site
Background
Historically, the use of proprietary statistical programming languages entailed the inclusion of general statements within the Statistical Analysis Plan (SAP) regarding the software and version employed for generating analyses. However, with the increasing adoption of open-source statistical programming languages, there is a necessity to provide detailed metadata for each package used, as a general statement is no longer adequate.
Mission
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.
Proposal
PHUSE Working Group Request
Presentation
PHUSE/FDA Quarterly meeting presentation. Presented on 16OCT2024.