PHUSE Regulatory Referenced Final Deliverables 

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

Analysis Data Reviewer's Guide (ADRG) Package The ADRG provides regulatory agency reviewers an orientation to the submitted analysis data in a consistent way and usable format. This Package includes information on the 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 1.2, 23-Jul-2019
ADRG Example using CDISC Pilot Data without legacy conversion ADRG Sample CDISC Pilot 23-Jul-2019
ADRG Example with a conversion from legacy analysis data to ADaM ADRG Example 1 with LDCP 23-Jul-2019
ADRG Example with a conversion from legacy tabulation data to SDTM to ADaM ADRG Example 2 with LDCP 23-Jul-2019
ADRG Example without a legacy conversion ADRG Sample 9999 23-Jul-2019
ADRG Template with optional Legacy Data Conversion Plan appendix ADRG Template with LDCP Version 1.2, 23-Jul-2019
Summary of changes to ADRG Template Version 1.2 ADRG Template with LDCP x1.2 - Summary of Changes 23-Jul-2019

 

Clinical Study Data Reviewer's Guide (cSDRG) Package, including Legacy Data Conversion Plan and Report (LDCP) appendix The cSDRG provides regulatory agency 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 cSDRG Completion Guidelines Version 1.4, 10-Jul-2019
cSDRG Example with a conversion from older version of SDTM to newer SDTM LDCP Example 2 with Appendix Version 1.0, 01-Nov-2018
cSDRG Example with a conversion from legacy tabulation data to SDTM LDCP Example 1 with Appendix Version 1.0, 01-Nov-2018
cSDRG Example without a legacy conversion cSDRG Example ABC123 Version 1.0, 01-Nov-2018
cSDRG Example without a legacy conversion but showing a conversion to integrated SDTM cSDRG Example 002A 01-Nov-2018
cSDRG Template with optional Legacy Data Conversion Plan appendix cSDRG Template with LDCP Version 1.3, 01-Nov-2018
Examples of traceability diagrams All Conversion Traceability Data Flows Version 1.0, 01-Nov-2018

 

Nonclinical Study Data Reviewer Guide (SDRG) Package The nSDRG provides regulatory agency 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 1.1, 19-Mar-2017
nSDRG Template nSDRG Template Version 1.1

 

Study Data Standardization Plan (SDSP) Package The SDSP documents the data standardization approach for clinical and nonclinical studies within a development program. This Package includes information on the CBER appendix, with proposed domain/variable usage. The SDSP Package includes the templates, completion guidelines, sponsor implementation guide, and examples.
SDSP Asthma Example without CBER appendix SDSP Example Template Asthma Version 1.0, 16-Jan-2018
SDSP Completion Guidelines SDSP Completion Guidelines Version 1.0, 16-Jan-2018
SDSP Oncology Example without CBER appendix SDSP Example Template Oncology Version 1.0, 16-Jan-2018
SDSP Sponsor Implementation Guide SDSP Sponsor Implementation Version 1.0, 16-Jan-2018
SDSP Template with optional CBER appendix SDSP Template Version 1.0, 16-Jan-2018
SDSP Vaccine Example with CBER appendix SDSP Example Template Vaccine Version 1.1, 24-Mar-2018

 

 

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