Concept: Template → Study
A Template EDL (Template Expected Document List) defines "which documents are expected at a level" and can be reused across studies; its entries are Template Expected Documents. When a study runs Plan Study, the chosen Template EDL is copied into the study-level EDL and its EDL Items (runtime entries point back to the source template).
Template EDLs support hierarchical nesting: the Parent field lets country/site templates inherit from a study template (e.g. Standard | Study Level → Standard | Country Level → Standard | Site Level).
Creating a Template EDL
Admin Setup → Template Expected Document Lists → create:
| Field | Notes |
|---|---|
| Name | Template name (required, unique) |
| Level | Study / Country / Site |
| Milestone Type | Optional; restricts the template to a milestone type |
| Parent | Optional; parent template for inheritance |
After saving, add Template Expected Document entries in the EDL Item Templates section of the template detail page.
Template Expected Documents (EDL Item Templates)
Admin Setup → Template Expected Documents aggregates all entries; each defines one expected-document template:
| Field | Notes |
|---|---|
| Name | Entry name, e.g. Clinical Study Report (CSR) |
| Template EDL | The owning template (required) |
| Type / Subtype / Classification | The document taxonomy triple (from Document Types, not editable) |
| Requiredness | Required: Required / Not Required / Pending Decision |
| # Expected | Expected steady-state count |
| Department | Owning department, e.g. Biostatistics, Data Management |
| Study Team Role / Study Organization Role / Study Product Role | Binds responsible roles for role-based expected documents |
| Milestone Type / Owning Milestone Type | The owning milestone type, e.g. IR - First Study Site Initiated |
| Auto-assign Version Number | Auto-assign document version numbers |
Note
The product ships hundreds of Template Expected Documents (CSR, Annotated CRF, Audit Certificate, etc.) — reuse them as-is or adjust to your SOP.
How Template Changes Affect Studies
| Field | Meaning |
|---|---|
| Template Behavior | Reuse / Update (update existing study entries) / Create (create new entries) |
| Fields to Update | Scope of pushed changes, multi-select: # Expected, Requiredness |
After a template change, the system applies Template Behavior and Fields to Update to decide whether to sync studies already using the template — "change once, apply to many studies".
Applying to a Study
While the study is in Candidate state, run All Actions → Plan Study, pick the Template EDL and Milestone Master Set, enter the study start date, and the system generates the study-level EDL (see Study Hierarchy).
Required Permissions & Roles
| Type | Permission | Controls |
|---|---|---|
| Object | Template EDL / Template Expected Document: Create, Read, Edit | Maintaining template lists and entries |
Clinical Application Administrator manages all templates; Document Contributor is read-only.