Appendix 1-CDER Process for Adoption of Standard.pdf
PDF 169 KB Posted
- Attached to
- Regulatory Review Support Federal contract opportunity
- Solicitation number
- RFP-12-223-SOL-00161
About this file
Appendix 1 - CDER Process for Adopting a Standard
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 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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Text version
CDER Process for Adoption of Standard C
D
ER
EC
P ro je ct T ea m
P ro je ct
In iti at or
(s
Im pa ct ed
C D
E R
O ffi ce
(s
D S
P B
No
(3) Complete
Scope Proposal Document
(20)Review proposal
(18)Review project proposal
(19)Proceed with
Proposal?
(2)Will the project require modification or creation of a standard
(17)Define Implementation plan
Yes
(11) Formalize CDER business process, IT & Data requirerments, and review with previously defined stakeholders
(5) Review Standards Proposal
Scope Proposal
(6)Proceed with
Proposal?
(25) Implement Standard
(10)Recommend appropriate center/
FDA team participation
Yes
Postpone or end Development
(21)Proceed with
Proposal?
(23)Review proposal
Yes
Yes
No
No
(24) Proceed with
Proposal?
(13)Does standard meet need?
No
(1)Define scope of project and justification
No
(22)Does CDER EC have to review?
Yes
No
(7)Does CDER EC have to review?
(8)Review proposal
Yes
(9) Proceed with
Proposal?
Yes
No
No
Yes
(12) Perform appropriate testing to validate concept
(14)Does the standard need to be modified?
Yes
No (15)Will the project require IT infrastructure?
(16)Begin IMAB/ ITIM ProcessYes
Yes
See Create/ Modify
Standard Process
From Create/ Modify
Standard No
Complete appropriate template prior to review by DSPB
CDER Process for Creating/Modifying a Standard in Support of Adoption
D
E R
E C
P ro je ct
In iti at or
(s
Im pa ct ed
C D
E R ce
(s
P ro je ct
T ea m D
S P
B C ro ss
C en te r/
D S
C /S
D O
No
Yes Yes
No
No
NoYes
Scope Proposal
Yes
Define and Formalize requirements with previously defined stakeholders
(10)Review project proposal
(5) Review Standards Proposal
(11)Proceed with
Proposal?
Postpone or end proposed modification
(8)Review proposal
(10)Determine appropriate center/
FDA team participation
(13)Proceed with
Proposal?
Proceed with Proposal?
SDO change/ creation process
(7)Does CDER EC have to review?
(3) Prepare Scope proposal for standard changes
(9) Proceed with
Proposal?
Need to Create/ Modify Standard
To Proof of Concept
No
Implemeting a Standard th er
S ta ke ho ld er s
(E C
, I m pa ct ed ce s et c.
D S
P B o r P ro je ct pe ci fic
A dv is or y G ro up
Im pl em en ta tio n Te am
Finalize project Plan and engage advisory structure
Execute Project plan
Review Project updates and implementation artifacts
Make Changes to Project Plan
Should other stakeholders review changes for approval?
Yes
Review Final Project plan and
Approach Should Changes be made to Project Plan
No
Is Project Plan Complete?
Yes
Stand up Change control board and enter
Maintenance
Review with necessary stakeholders
Yes
No
No
Maintenance – Change Control ha ng e C on tro l B oa rd D
S C
/S D
O P ro je ct In iti at or (s
D
S P
B O th er ta ke ho ld er s
Evaluate change request and define scope of change
Change request
Is the scope a major one requiring a full project approach
Review change request
See Process:
Create/Modify
Standard
Yes
Should the DSPB review
Yes
Is the change worth pursuing? Yes
Communicate disposition
No
No Communicate requirements to
SDO
Proceed with Change?
Engage SDO Change Process
Yes
No
Implement Change
Do other Stakeholders need to weigh in?
Yes
Review Change Request
Yes
No
Proceed with Change?
Yes
No
No
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