The Four-Level Structure
The milestone template system has four levels, applied to a study as a master set during Plan Study:
| Level | Object | Purpose |
|---|---|---|
| Master set | Template Milestone Master Set | Packages the study/country/site initialization sets |
| Set | Template Milestone Set | One level's milestone collection (hangs on a Story Event) |
| Milestone | Template Milestone | A single milestone template: type, sequence, duration, completion rules |
| Dependency | Template Milestone Dependency | Previous → next date derivation |
Template Milestone Master Sets
A Template Milestone Master Set packages three initialization sets into one choice for the study (Admin Setup → Template Milestone Master Sets):
| Field | Notes |
|---|---|
| Name | Master set name (required, unique) |
| Study Initialization Set | Study-level initialization set (required, must be a Study-level set) |
| Study Country Initialization Set | Country-level initialization set (required) |
| Study Site Initialization Set | Site-level initialization set (required) |
Note
The product ships the Standard Study Level master set, binding the Generic Study / Country / Site Candidate initialization sets — ready to use.
Template Milestone Sets
A Template Milestone Set is one level's collection of milestone templates, hanging on a Story Event that decides when the set is applied to a study:
| Field | Notes |
|---|---|
| Name | Set name (required) |
| Level | Required: Study / Country / Site |
| Story Event | Trigger event (required), e.g. Candidate Study, Study Management, Protocol Amendment |
| Template Country | Optional; restricts the set to one country |
The product ships 14 standard sets (Generic Study Candidate, Study Management, First Study Site Initiated, Study Closing, Site Initiated, etc.); events carry a creation trigger (Initialization / State Change / Ad Hoc).
Template Milestones
A Template Milestone is the blueprint of a study milestone (Admin Setup → Template Milestones):
| Field | Notes |
|---|---|
| Milestone Type | Required, e.g. Study Start, First Subject In (FSI), Last Subject Last Visit (LSO), Database Lock |
| Milestone Set | The owning set (required) |
| Sequence | Order within the set |
| Expected Duration (Days) | Expected duration (0–2000 days) |
| Expected Duration - Resubmit | Expected duration for resubmissions |
| Template EDL | Optionally bind a Template EDL to generate expected documents |
| Template IRB / EC Type | Central / Local |
| Autocomplete | All Dependencies / Any Dependency / Off |
| Gating Override Eligible | Whether the dependency gate may be overridden |
| Milestone Category | Core Milestones / Startup / Monitoring / Inspection Readiness etc. |
Templates come in four object types — Standard (default), Point in Time, Event, Monitoring Event — with 100+ seeded milestone templates.
Template Milestone Dependencies
A Template Milestone Dependency defines a previous → next relationship between two template milestones (Admin Setup → Template Milestone Dependencies):
| Field | Notes |
|---|---|
| Milestone Set | The owning set (required) |
| Previous Template Milestone | Previous milestone (required) |
| Next Template Milestone | Next milestone (required) |
| Date Offset | Date offset (0–3650 days) |
| Dependency Type | The object type |
The dependency type decides how dates derive:
| Type | Meaning |
|---|---|
| Finish to Finish (default) | Next date = previous actual finish + Date Offset |
| Rollup (min date) | Rollup of the minimum date (e.g. country FSI into study FSI) |
| Rollup (max date) | Rollup of the maximum date (e.g. country LSI/LSO into study LSI/LSO) |
Note
The dependency gate is enforced on the study side: Mark Complete on a downstream milestone is rejected while the upstream is incomplete, unless a Gating Override Date is set.
Applying to a Study
When All Actions → Plan Study picks a master set, the system generates milestones from the three initialization sets as the study enters Planning; countries/sites apply their own templates when entering Initiating. Study milestones start as Unplanned and are scheduled via Plan Milestone (see Milestones).
Required Permissions & Roles
| Type | Permission | Controls |
|---|---|---|
| Object | All four template objects: Create, Read, Edit | Maintaining master sets, sets, milestone and dependency templates |
Clinical Application Administrator manages all milestone templates; Document Contributor is read-only.