Type IA Variation Submission Plan 52
This submission plan coordinates owners, milestone dependencies, and readiness controls for Sacuvance. Teams use it to monitor timeline health, resolve blockers, and decide whether content is publish-ready for sequence assembly. Readiness is calculated from deterministic component approval status across linked dossiers, rather than manual estimates. Use the edit and content assembly actions to move directly into corrective work.
Plan ID
PLAN-052
Application
Target Date
2025-03-09
Status
In Progress
Owner
Lieselotte van der Berg
Created
2022-06-23
Readiness Score
5/100
Calculated from 1 approved of 20 linked content components.
Blockers
9 components are missing approval snapshots.
7 components still have unresolved review comments.
GMP inspection findings to be resolved
Milestone Dependency Strip
Statistical analysis plan lock
Data cutoff
QC check
Protocol finalization
Dispatch submission
Module 5 compilation
Publishing start
CSR review
Regulatory review
| Milestone | Due Date | Owner | Dependencies | Dependency Indicators | Completed |
|---|---|---|---|---|---|
| Statistical analysis plan lock | 2025-01-31 | Dmitri Volkov | None | Independent | No |
| Data cutoff | 2025-02-22 | Nadia Petrova | None | Independent | Yes |
| QC check | 2025-04-20 | Tomoko Ikeda | PLAN-052-MS-002 | Dependent | No |
| Protocol finalization | 2025-05-08 | Tomoko Ikeda | None | Independent | Yes |
| Dispatch submission | 2025-05-28 | Dmitri Volkov | None | Independent | No |
| Module 5 compilation | 2025-06-24 | Lieselotte van der Berg | PLAN-052-MS-005 | Dependent | Yes |
| Publishing start | 2025-07-27 | Tomoko Ikeda | PLAN-052-MS-006 | Dependent | Yes |
| CSR review | 2025-09-05 | Aisha Okonkwo | PLAN-052-MS-007 | Dependent | Yes |
| Regulatory review | 2025-09-23 | Marcus Webb | PLAN-052-MS-008 | Dependent | Yes |