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.

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.

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 Q1 2025
Project Team Kick-Off. Received feedback from both the FDA and PHUSE The cSDRG and ADRG project team (Christine Rossin) on the enhancements needed for Open-Source submission and ADRG documentation.

Objectives & Deliverables	Timelines
White Paper	Q1 2025