PHUSE Deliverables
Q42020 Published Deliverables
Deliverables calling for Feedback
The Safety Analytics Working Group held a Workshop at CSS based on Planning and Interpreting Safety Analyses for Integrated Summaries. Click here to view the recording and here for the slides.
The CDISC Implementation Primer project has put together a series of short, animated videos as well as helpful links to introduce newcomers to the suite of CDISC Standards. Click here to read the standards.
NOW LIVE! Take a look at our recently published update on COVID-19's impact on CTT. This gives update to some of the initiatives that have changed since the initial discussion on the 'Impacts of COVID-19 on Clinical Trial Transparency and Document Disclosure PHUSE CTT Project'. Read more here.
There are no deliverables currently on review.
If you wish to view our extensive list of published deliverables, click the link above.
| 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||
| Reviewer's Guide (nSDRG) 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. | Study DataStandardisation 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. |