Appendix 4-CSC Process Configuration.pdf
PDF 201 KB Posted
- Attached to
- Regulatory Review Support
- Solicitation number
- RFP-12-223-SOL-00161
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Appendix 4 - CSC Process Configuration
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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 5- CSC Process Configuration Map.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
Industry
Submisssion
CDER Regulatory
Review
Quality Control (Open
CDISC)
Regulatory Research and
Review Coordination
Support
CSC Board
· Tools Subgroup
· Future Tools
· Horizon Scanning
· Change Control
· Data Standards
Leads
Tools IT Environment
· IT Support
· ATO
· Tools Production
· O/M
Clinical Trials Repository
· Data Model
· Portes
Organizational Change
Management
· Training
· Communication
· Staff Development
· Implementation
· Tool SMEs
Governance
· MaPPs
· Policies
· Guides
Regulatory
Review
CDER Regulatory
Research
War Room
· Data Visualization
· Tool Introduction
| CSC Process Configuration.vsd |
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