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 11th June. The Open-source Technologies in Regulatory Submissions White Paper – Deadline 10th June. The Recommendations for Populating Control Type (TCNTRL) with CDISC SEND Controlled Terminology White Paper – Deadline 27th May. 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) and/or the FDA Guidance on Providing Regulatory Submissions in Electronic Format - Standardised 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 Version 1.2, 23-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-2019 | 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-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. |