Appendix 5- CSC Process Configuration Map.pdf
PDF 237 KB Posted
- Attached to
- Regulatory Review Support
- Solicitation number
- RFP-12-223-SOL-00161
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Appendix 5 - CSC Process Configuration Map
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Other files
| File | Type | Posted |
|---|---|---|
| RFP FDA-SOL-12-1100474 IDIQ Regulatory Review Support - Amendment 1 JGF.pdf | ||
| Revised RFP-12-223-SOL-00161.pdf | ||
| Amendment 1 - RFP-12-223-SOL-00161.pdf | ||
| Attachment 5 IDIQ Pricing Worksheet.xls | XLS spreadsheet | |
| Appendix 1-CDER Process for Adoption of Standard.pdf | ||
| Appendix 4-CSC Process Configuration.pdf | ||
| Appendix 2-CSC Future State.ppt | PPT presentation | |
| Appendix 3-CSC_Tools Timeline.ppt | PPT presentation | |
| Appendix 7-Application Review Process Model.ppt | PPT presentation | |
| RFP-12-223-SOL-00161.pdf | ||
| Appendix 6-CDER CS Technical and Functional Capability Phases.pdf |
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Text version
EDR
PORTES
SAS DM
(File Share)
SAS Clinical Data Integration eDISH
JMP Clinical
JReview
ToxVision
CDER Reviewers
CSC REVIEWER PORTAL*
Script LauncherEmpirica Signal
1 Mainframe 4 Server 3 LCD monitor 3 User
Configuration management database
1 Hub
Symbol Count Description Legend Subtitle
Legend
Data Validation/ Open CDISC
(Jreview, WebSDM, SAS, Script Launcher, Empirica Signal, ToxVision)
Results of Analyses
DAARTS
Fails quality checks?
Additional customization/ formatting of data sets needed?
Knowledge Management DB
Knowledge Management DB
INDUSTRY
ESG
Pre-market Regulatory
Submissions
Scoring Reports
TOOLS ENVIRONMENT*
CDER CSC REGULATORY RESEARCH
ENVIRONMENT*
“Room 1”
AERS/FAERS
CDRH HIGH PERFORMANCE COMPUTING
ENVIRONMENT*
“Room 3”
SENTINEL
CSC “WAR ROOM”
SCIENTIFIC ENCLAVE AT WO
JANUS CLINICAL TRIALS REPOSITORY
“Room 2”
SDTM Modified Views
Data Mart
OTHER SCIENTIFIC APPLICATIONS
“Room n”
“Data Marts” that will be replicated from Janus CTR at NCI until entire Janus application is migrated to WO
Test Environment
CDISC, HL7 and other Standards Organizations
CDER Assessment/Prioritization of Data Standards Development Efforts
CDER Facilitation of Data Standards Development and Refinement
Database of CDER Data Standards Development
Activities
Outside Groups/Organizations Pursuing Data Standards
Identify Errors from Prior Submissions
CDER Reviewer Input/Suggestions
Proactive communications to sponsors re: expectations/ requirements
Data feed to Scientific Enclave
Study Data Sets
**NEAR-TERM STATE FOR REGULATORY REVIEW AND
RESEARCH ACTIVITIES-- GOAL DATE END OF FY 2013
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