Appendix 6-CDER CS Technical and Functional Capability Phases.pdf
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- Regulatory Review Support Federal contract opportunity
- Solicitation number
- RFP-12-223-SOL-00161
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Appendix 6 - CDER CS Technical and Functional Capability Phases
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| RFP FDA-SOL-12-1100474 IDIQ Regulatory Review Support - Amendment 1 JGF.pdf | ||
| Amendment 1 - RFP-12-223-SOL-00161.pdf | ||
| Revised RFP-12-223-SOL-00161.pdf | ||
| Attachment 5 IDIQ Pricing Worksheet.xls | XLS spreadsheet | |
| Appendix 4-CSC Process Configuration.pdf | ||
| Appendix 3-CSC_Tools Timeline.ppt | PPT presentation | |
| RFP-12-223-SOL-00161.pdf | ||
| Appendix 1-CDER Process for Adoption of Standard.pdf | ||
| Appendix 2-CSC Future State.ppt | PPT presentation | |
| Appendix 5- CSC Process Configuration Map.pdf | ||
| Appendix 7-Application Review Process Model.ppt | PPT presentation |
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CDER Computational Science Center Technical and Functional Capability Phases
The CSC was evaluated over the course of three “Phases” of development, during which technical and functional capabilities are expected to be implemented, and their benefits realized, incrementally.
Figure 1 CSC Phase I (present – FY12) – Major CSC‐enabled capabilities include Portes and Janus Clinical Trials Repository (CTR) entering development and testing, and development and deployment of training and data standards.
Key
Environment, database, or interface under development
Data flow
Alternate data flow
Data Source Under Development at NCI Legacy Converted Data
CTR Staging Database
SDTM Data Views
Janus CTRLoad
FDA
CDER CSC
Regulatory Review Environment
Analysis Environment
HPC
Environment
Converted Legacy File
Servers
CDER EDR
Reviewer Portal
Data Environment
Portes Custom Views
Converted Legacy Data
Staging Servers
Regulatory Research EnvironmentStaging
Servers
Development
Operational
Knowledge Management
FAQ
Database
Review ResultsDesktop-based Tools (JMP, SAS, R, etc.)
Server-based Tools (JReview, WebSDM/Empirica Study, SAS, Script Launcher, Empirica Signal, etc.)
Other Services IT component services (E.g., Single Sign-on) Common error database Public community code repos.(Wiki) Change management Manage organization Hardware and software support Maintain technology infrastructure Help desk support Analysis support Data management
Data Standards Format (SDTM) Fit for business purpose Content Data messaging Define analysis requirements Sponsor communication
Review Management
Assign Track Review Manage
Training People Process Technology
Innovation Policy Tools Process Technology
Reporting Data validation reporting Error reporting
Collaboration Traction eRoom Adobe Connect MeetingPlace
Functional Capabilities
Open CDISC/CDER Data Validation Program (if standardized data)
DARRTS
Figure 2 CSC Phase II (FY13) – Major CSC‐enabled capabilities include Portes and the Janus CTR entering production, and continued training and data standards efforts.
Data flow
Alternate data flow
Key
Data flow
Alternate data flow
Data Source Under Development at NCI Legacy Converted Data
CTR Staging Database
SDTM Data Views
Janus CTRLoad
FDA
CDER CSC
Regulatory Review Environment
Analysis Environment
HPC
Environment
Converted Legacy File
Servers
CDER EDR
Reviewer Portal
Data Environment
Portes Custom Views
Converted Legacy Data
Staging Servers
Regulatory Research EnvironmentStaging
Servers
Development
Operational
Knowledge Management
FAQ
Database
Review ResultsDesktop-based Tools (JMP, SAS, R, etc.)
Server-based Tools (JReview, WebSDM/Empirica Study, SAS, Script Launcher, Empirica Signal, etc.)
Other Services IT component services (E.g., Single Sign-on) Common error database Public community code repos.(Wiki) Change management Manage organization Hardware and software support Maintain technology infrastructure Help desk support Analysis support Data management
Data Standards Format (SDTM) Fit for business purpose Content Data messaging Define analysis requirements Sponsor communication
Review Management
Assign Track Review Manage
Training People Process Technology
Innovation Policy Tools Process Technology
Reporting Data validation reporting Error reporting
Collaboration Traction eRoom Adobe Connect MeetingPlace
Functional Capabilities
Open CDISC/CDER Data Validation Program (if standardized data)
DARRTS
Figure 3 CSC Phase III (FY14 – FY27) – Major CSC‐enabled capabilities include the integration of Janus with CSC tools, integration with a Knowledge Management (KM) platform, and continued training and data standards efforts.
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