PhUSE Final Deliverables Catalog

The PhUSE 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 Working Groups 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 ADRG Completion Guidelines, an ADRG Template, and examples. This document is referenced in the FDA Study Data Technical Conformance Guide, 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

cSDRG Packages

Updated cSDRGs to include a Clinical Legacy Data Conversion Plan & Report section. There are three scenarios in which the Example Documents were updated: 1) conversion of clinical legacy tabulation data to SDTM after legacy analysis had been created, 2) conversion of SDTM IG 3.1.1 clinical data to a version of SDTM that is supported in the Data Standards Catalog, 3) no conversion was done. 

cSDRG Completion Guidelines v1.3 – Nov 2018 cSDRG Template with LDCP v1.3 – Nov 2018
LDCP Example 1 with Appendix v1.0 – Nov 2018 LDCP Example 2 with Appendix v1.0 – Nov 2018
cSDRG Example 001A v1.0 – Nov 2018 cSDRG Example 002A – Nov 2018
cSDRG Example ABC123 v1.0 – Nov 2018 All Conversion Traceability Data Flows v1.0 – Nov 2018

 

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 SDRG Completion Guidelines, an 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 Reviewer's Guide – Example 001a 06-Aug-2014 Study Data Reviewer's Guide – Example 002a 06-Aug-2014
Study Data Reviewer's Guide – Example abc132 06-Aug-2014  
Nonclinical Study Data Reviewer's Completion Guidelines v1.1 19-Mar-2017 Nonclinical Study Data Reviewer's Guide Template v1.1

SDSP Packages

The CDER and CBER Study Data Standardization Plan (SDSP) establishes and documents a plan for describing the data standardisation approach for clinical and nonclinical studies within a development programme. The SDSP assists the FDA in identifying potential data standardisation issues early in the development programme. The SDSP Work Package includes SDSP Completion Guidelines, an SDSP Template, an SDSP Sponsor Implementation Guide, and example SDSPs. This document is referenced in the FDA Guidance Providing Regulatory Submissions in Electronic Format – Standardized Study Data, December 2014 (click here to view) and the FDA Study Data Technical Conformance Guide, March 2018 (click here to view). 

SDSP Completion Guidelines v1.0 WP001 16-Jan-2018 SDSP Sponsor Implementation v1.0 WP002 16-Jan-2018
Study Data Standardization Plan Template v1.0 TP001 16-Jan-2018 SDSP Example Template Asthma v1.0 TP002 16-Jan-2018
SDSP Example Template Oncology v1.0 TP003 16-Jan-2018 SDSP Example Template Vaccine v1.1 TP004 24-Mar-2018

 

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