Appendix 5- CSC Process Configuration Map.pdf
PDF 237 KB Posted
- Attached to
- Regulatory Review Support Federal contract opportunity
- Solicitation number
- RFP-12-223-SOL-00161
About this file
Appendix 5 - CSC Process Configuration Map
View the file
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 6-CDER CS Technical and Functional Capability Phases.pdf | ||
| Appendix 1-CDER Process for Adoption of Standard.pdf | ||
| Appendix 2-CSC Future State.ppt | PPT presentation | |
| Appendix 7-Application Review Process Model.ppt | PPT presentation |
Show all 11
On GovTribe
Work with this file on GovTribe
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
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
Page-1�
File details come from the government source that posted it. Updated .