Type II Variation Submission Plan 1
This submission plan coordinates owners, milestone dependencies, and readiness controls for Ocluvance. 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-001
Application
Target Date
2025-07-25
Status
Approved
Owner
Lieselotte van der Berg
Created
2022-11-02
Readiness Score
10/100
Calculated from 2 approved of 20 linked content components.
Blockers
13 components are missing approval snapshots.
5 components still have unresolved review comments.
Publishing tool version upgrade in progress
Awaiting CMC stability data lock
Module 5 CSR review pending sign-off
Milestone Dependency Strip
Protocol finalization
Data cutoff
Authority acknowledgement expected
CSR draft
Statistical analysis plan lock
| Milestone | Due Date | Owner | Dependencies | Dependency Indicators | Completed |
|---|---|---|---|---|---|
| Protocol finalization | 2025-01-30 | Aisha Okonkwo | None | Independent | Yes |
| Data cutoff | 2025-02-19 | Aisha Okonkwo | None | Independent | No |
| Authority acknowledgement expected | 2025-04-21 | Aisha Okonkwo | None | Independent | Yes |
| CSR draft | 2025-05-07 | Carlos Mendez | PLAN-001-MS-003 | Dependent | No |
| Statistical analysis plan lock | 2025-05-21 | Carlos Mendez | PLAN-001-MS-004 | Dependent | Yes |