If you wish to view the extensive list of all PHUSE published deliverables, click here.
Q12021 Published Deliverables
Deliverables calling for Feedback
The Industry Experiences Submitting Standardised Study Data project has published the 'FDA and PMDA Study Data Submission Distinctions' White Paper. The focus of this document is to highlight the similarities and differences between the FDA and PMDA recommendations and requirements when submitting standardised CDISC data.
The Analysis and Displays Associated with Safety Topics of Interest- Focus on Phase II to IV Clinical Trials White Paper provide recommendations on analyses and displays to sponsors who are planning analyses for safety topics of interest for Phase II to IV clinical trials and integrated summary documents (or other documents in which analyses of safety are of interest).
The Data Listings in Clinical Study Reports White Paper – Deadline 25th June.
Please email all feedback to workinggroups@phuse.global.
| Regulatory Deliverables |
| These documents below are referenced in the FDA Study Data Technical Conformance Guide (click here to view |
| FDA |
| Study Data Standards Resources). These are also referenced in the PMDA Technical Conformance Guide on Electronic Study Data Submissions (click here to view PMDA New Drug Review with Electronic Data). |
Integrated Analysis Data Reviewer’s Guide (iADRG) Package Version 1.0, 18 September 2023 | The cSDRG and ADRG apply to a single study. Sponsors have used these templates when creating a reviewer's guide for integrated Study Data and reviewer's guide for integrated Analysis Data. The template has to be changed in order to document the information for multiple studies. | |||
Bio-research Monitoring Data Reviewers Guide (BDRG) Package Version 3.0, 28 June 2023 | The BDRG provides regulatory agency reviewers an orientation to the submitted Bioresearch Monitoring (BIMO) data in a consistent way and usable format. The BDRG Package includes Introduction and Overview, Template, Completion Guidelines and Examples. | |||
Nonclinical Study Data Reviewer's Guide (nSDRG) Package Version 1.2 08 April 2022 | 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. | |||
Analysis Data Reviewer's Guide (ADRG) Package Version 1.2, 23-18 July - 2019 | 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. | |||
Version 1. | 4, 10-Jul-20193, 2 November 2018 | 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 | .Nonclinical Study Data Reviewer's Guide (nSDRG) Package Version 1.1, 19-Mar-2017 | 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. |
Study Data Standardisation Plan (SDSP) Package Version 1.0, 16 | -Jan-January 2018 | The SDSP documents the data standardisation 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 template, completion guidelines, sponsor implementation guide, and examples. |