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.

Brand New: 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

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

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, October 2017 (click here to view). 

Preliminary recommendations for Traceability using Define-XML Version 2.0: 15-DEC-13: The Define-XML 2.0 Specifications, “Metadata Submission Guidelines” (MSG) V1 and the “ADaM Implementation Guide” V1 documents, describe metadata for SDTM, Analysis Data Sets (ADS) [*1] and Analysis Results. The Define-XML specification document is expected to handle the technical implementation of what is described in less technical terms in implementation guidelines documents; however, it must be recognized that the Define-XML 2.0 Specifications document is reflecting the current version of the Metadata requirements, while the implementation guidelines are not updated yet. 

Traceability: Current State Analysis. Version 1.0: 21-AUG-13: Addresses the challenges of integrating and converting data across studies. To define traceability considerations and best practices for study level and integrated dataset conversion for a variety of different data flow scenarios.

Analysis Data Reviewer's (ADRG) Version 1.1: 01-NOV-16: 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 2015 - click here to view.

Study Data Reviewer's Guides (SDRG) 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.

Standardizing Data within the Inspection Site Selection Process Final Version: 26-MAY-16: "Guidance for Industry: Providing submissions in electronic format.

CDISC Foundational Standards in RDF Final Version: 30-AUG-15: CDISC has officially taken this on

Metadata Definitions Document Version 1.0: 15-JULY-14: This document contains definitions and example usage for commonly used terms relating to metadata and master data management. 

 

 

 

 

 

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