Type IB Variation Submission Plan 3

Open Content Assembly

This submission plan coordinates owners, milestone dependencies, and readiness controls for Cardivex. 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-003
Application
PMDA-2022-0003
Target Date
2025-02-15
Status
Blocked
Owner
Marcus Webb
Created
2022-05-30
Readiness Score
5/100
Calculated from 1 approved of 20 linked content components.
Blockers
13 components are missing approval snapshots.
7 components still have unresolved review comments.
Milestone Dependency Strip
Statistical analysis plan lock
Module 3 update
Data cutoff
Protocol finalization
Publishing start
Dispatch submission
Quality review
Module 5 compilation
QC check
MilestoneDue DateOwnerDependenciesDependency IndicatorsCompleted
Statistical analysis plan lock2025-01-21Aisha OkonkwoNoneIndependentNo
Module 3 update2025-03-01James O'BrienPLAN-003-MS-001DependentYes
Data cutoff2025-03-25Carlos MendezNoneIndependentYes
Protocol finalization2025-04-04Nadia PetrovaPLAN-003-MS-003DependentYes
Publishing start2025-05-23Priya SharmaNoneIndependentYes
Dispatch submission2025-06-26Aisha OkonkwoPLAN-003-MS-005DependentYes
Quality review2025-08-14Lieselotte van der BergPLAN-003-MS-006DependentNo
Module 5 compilation2025-09-17Nadia PetrovaNoneIndependentNo
QC check2025-10-08Priya SharmaNoneIndependentNo