PHUSE Deliverables
Q42020 Published Deliverables | Deliverables calling for Feedback |
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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) 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. |