PhUSE CS Final Deliverables Catalog

The PhUSE CS Working Groups bring together academia, industry, technology providers and regulatory agencies including the FDA to collaborate on projects to address unmet computational science needs. This catalog provides a single point of reference for content developed by the CS Working Group projects.

SOP: PhUSE has been working on producing a Standard Operating Procedure for Version Control of PhUSE Deliverables. We are pleased to announce this has now been agreed by the Steering Committee and PhUSE Board of Directors. Moving forward, we ask all members that are working towards a deliverable for review and approval, to start using this agreed process. If you have any queries, please reach out to your Working Group Lead.

Flow Chart

Working Practice Process

Deliverables

ADRG Packages

The ADRG provides FDA Reviewers an orientation to the submitted analysis data in a consistent and usable format. The ADRG Work Package includes a ADRG Completion Guidelines, ADRG Template, and examples. This document is referenced in the FDA Study Data Technical Conformance Guide release, March 2018 - click here to view.

ADRG Completion Guidelines V1.1 26-Jan-2015 ADRG Template 26-Jan-2015
Analysis Data Reviewers Guide Sample 16-Oct-2014 Analysis Data Reviewers Guide Sample CDISC Pilot 16-Oct-2014

SDRG Packages for Clinical and Nonclinical

The SDRG provides FDA Reviewers with additional context for SDTM or SEND datasets received as part of a regulatory submission. The SDRG Work Package includes a SDRG Completion Guidelines, SDRG Template, and example SDRGs. This document is referenced in the FDA Study Data Technical Conformance Guide - click here to view.

SDRG Completion Guidelines V1.2 26-Jan-2015 SDRG Template 26-Jan-2015
Study Data Reviewers Guide - example 001a 06-Aug-2014 Study Data Reviewers Guide - example 002a 06-Aug-2014
Study Data Reviewers Guide - example abc132 06-Aug-2014  
Nonclinical Study Data Reviewers Completion Guidelines V1.1 19-Mar-2017 Nonclinical study Data Reviewers Guide Template V1.1

SDSP Packages

The CDER and CBER Study Data Standardization Plan (SDSP) establishes and documents a plan for describing the data standardization approach for clinical and nonclinical studies within a development program. The SDSP assists FDA in identifying potential data standardization issues early in the development program. The SDSP Work Package includes SDSP Completion Guidelines, SDSP Template, SDSP Sponsor Implementation Guide, and example SDSPs. This document is reference in the FDA Guidance Providing Regulatory Submissions In Electronic Format - Standardized Study Data release, December 20014 (click here to view) and the FDA Study Data Technical Conformance Guide release, March 2018 (click here to view). 

SDSP Completion Guideline. Version 1.0 WP001 16-Jan-2018 SDSP Sponsor Implementation. Version 1.0 WP002 16-Jan-2018
Study Data Standardization Plan Template . Version 1.0 TP001 16-Jan-2018 SDSP Example Template Asthma. Version 1.0 TP002 16-Jan-2018
SDSP Example Template Oncology. Version 1.0 TP003 16-Jan-2018 SDSP Example Template Vaccine  . Version 1.1 TP004 24-Mar-2018

 

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