PHUSE Archived Deliverables Catalog

These documents are referenced in the FDA Study Data Technical Conformance Guide, (click here to view) and/or FDA Guidance providing Regulatory Submissions in Electronic Format - Standardized Study Data, (click here to view)

Analysis Data Reviewer Guide (ADRG) Package The ADRG provides FDA reviewers an orientation to the submitted analysis data in a consistent way and useable format. This package includes information on Legacy Data Conversion Plan and Report (LDCP) appendix. The ADRG Package includes the template, completion guidelines, and examples
ADRG Completion Guidelines ADRG Completion Guidelines: Version 1.1, 26-Jan-2015
  ADRG Completion Guidelines: Version 1.0, 04-May-2014
ADRG Example using CDISC Pilot Data without legacy conversion ADRG Sample CDISC Pilot: 16-Oct-2014
  ADRG Sample CDISC Pilot: 13-May-2014
ADRG Example ADRG Sample: 16-Oct-2014
  ADRG Sample: 13-May-2014
ADRG Template ADRG Template: 26-Jan-2015
  ADRG Template: 04-May-2014

 

Nonclinical Study Data Reviewer Guide (nSDRG) Package The nSDRG provides FDA reviewers with additional context for nonclinical tabulation datasets received as part of a regulatory submission. The nSDRG Package includes the template and completion guidelines
nSDRG Completion Guidelines nSDRG Completion Guidelines: Version 1.0
nSDRG Template nSDRG Completion Guidelines Template: Version 1.0

 

Clinical Study Data Reviewer Guide (cSDRG) Package The cSDRG provides FDA reviewers an orientation to the submitted tabulation data in a consistent way and usable format. This package includes information on the Legacy Data Conversion Plan and Report (LDCP) appendix. The cSDRG Package includes the template, completion guidelines, examples, and example traceability diagrams
cSDRG Completion Guidelines SDRG Completion Guidelines: Version 1.2, 26-Jan-2015
cSDRG Template SDRG Template: 26-Jan-2015
cSDRG Examples SDRG Example 001A
  SDRG Example 002A
  SDRG Example ABC123
  SDRG– Example 001a: 06-Aug-2014
  SDRG– Example 002a: 06-Aug-2014
  SDRG– Example abc132: 06-Aug-2014
cSDRG Completion Template SDRG Completion Guidelines: 13-May-2013

 

Working Group Year White Paper
Nonclinical Topics 2017

Investigating Endpoint Modeling: Nonclinical Biomarker Modeling: Version 1.0, 03-Jan-2017

Investigating Endpoint Modeling Biomarkers, ADA Data & Immunophenotyping: Version 1.0, 03-Jan-2017
     
Standard Analyses & Code Sharing 2017 Screen Shots of the Displays Created by JumpStart Programs (Word): Version 1.0, 17-Mar-2017
    Screen Shots of the Displays Created by JumpStart Programs (PDF): Version 1.0, 17-Mar-2017
  2014 Analyses and Displays Associated with Demographics, Disposition, and Medications in Phase 2-4 Clinical Trials and Integrated Summary Documents (PDF): Version 1.0, 07-Oct-2014
    Analyses and Displays Associated with Demographics, Disposition, and Medications in Phase 2-4 Clinical Trials and Integrated Summary Documents (Word): Version 1.0, 07-Oct-2014
    Analyses and Displays Associated with Thorough QT/QTc Studies: (PDF) Version 1.0, 11-Mar-2016. Word Version
    Analyses and Displays Associated to Non-Compartmental Pharmacokinetics - with a Focus on Clinical Trials: (PDF) Version 1.0, 25-Mar-2014
     
Data Transparency 2018 Clinical Trials Data Transparency Toolkit: Clinical Trial Transparency & Disclosure - A Global View: Version 1.0, 11-Dec-2018
     
Emerging Trends & Technologies 2016 Cloud Services: A Framework for Adoption in the Regulated Life Sciences Industry (PDF): Version 3.0, 18-Nov-2016
  2017 Alternative Transport: Transport for the Next Generation: Version 1.1, 20-May-2017
  2016  State of the SCE: Version 1.0, 29-Apr-2016
  2017 Clinical Development Design Framework: An Information Model to Capture Decision-making for the Medical Product Life Cycle: Version 1.0, 27-Sept-2017 
  2016 Introduction to the Clinical Development Design (CDD) Framework: Version 1.0, 01-Nov-2016
     
Optimizing the Use of Data Standards 2018 CSDRG XML Final Prototype Package: Version 1.0 10-Aug-2018 
  2014 Best Practices for Data Standards Implementation: Assigning VISITNUM to Unplanned Visits and Assigning EPOCH: Version 1.0
  2014 White Paper: Study Traceability in a Non-Linear Data Flow: Version 1.0
  2013 Traceability and Data Flow: Current State Analysis: Version 1.0
  2013 Preliminary Recommendations for Traceability Documentation Using Define-XML: Version 2.0

 

 

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