| 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). |
Bio-research Monitoring Data Reviewers Guide (BDRG) Package 22-June-2022 | 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, 18-Jul-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 1.3, 2-Nov-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 1.2 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. |
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. |