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Unlocking the Milestones and EDLs Object Model in Veeva Vault Clinical

  • Writer: Wolvio Solutions
    Wolvio Solutions
  • May 8
  • 4 min read

In Veeva Vault Clinical, the Milestones and Expected Document Lists (EDLs) object model plays a foundational role in managing clinical trial documentation, timelines, and inspection readiness. Though the model can appear complex at first glance, understanding its relationships and flows unlocks its full potential in powering automation, compliance, and proactive study management across eTMF, CTMS, and SSU functionalities.


The Milestones-EDL framework allows for dynamic planning and tracking of when specific documents are expected, based on trial events (called Milestones) at the Study, Study Country, or Study Site levels.


Key Data Model - Milestones & EDLs (Vault Clinical)
Key Data Model - Milestones & EDLs (Vault Clinical)

Milestones & EDLs Object Model Overview

At the heart of this model is a tiered template system that drives reusability and automation:

1. Template Milestone Master Set

The highest level configuration that organizes reusable Milestone Sets for different study scenarios.

2. Template Milestone Set

Defined under the Master Set, this is a collection of Template Milestones appropriate for a specific study phase, therapeutic area, or regulatory region.

3. Template Milestones

These are the blueprint Milestones that define when events should occur (e.g., Site Activation, First Subject In), and what documents are expected at those points.

Each Template Milestone might includes:

  • Dependencies (Previous/Next Milestones)

  • Associated Template Tasks

  • Template Expected Documents (EDL Items)


Story Event – Milestone Creation Trigger

The Story Event object controls when and how Milestones are created, using a picklist-based field called Milestone Creation Trigger with values like:

  • Initialization

  • Ad Hoc

  • State Change

  • Date-based

Story Events may also dictate which Template Milestone Set applies based on conditions like Study Type or Region, making this engine highly configurable.


Automated Milestone Generation

Milestones are automatically generated based on Lifecycle State transitions with appropriate Study, Study Country, Study Site.

Object

Lifecycle Stage Trigger (Start)

Milestone Scope

Study

Planning

Study-Level

Study Country

Initiating

Country-Level

Study Site

Qualifying

Site-Level

This makes the system responsive to operational progress, aligning documentation expectations with trial execution in real-time.


Milestones & EDLs Association: Two Approaches

1. Old Way (Pre EDL Refactoring)

Template Milestones link to Template Expected Documents, which are then inherited into Expected Document Lists (EDLs) at runtime. This was the traditional method, using template-based inheritance to generate EDLs and link documents.

Flow:

  1. Template Milestone → links to → Template Expected Documents (Template EDL Items) Each milestone template pre-defines which documents are expected.

  2. When a Milestone is created (based on Study, Study Country, or Study Site lifecycle stage or Story Event trigger):

    • Vault checks the associated Template Expected Documents

    • Creates an Expected Document List (EDL) instance

    • Generates individual Expected Document records for each expected document type (e.g., Protocol, IB, IRB Approval)

  3. The Expected Document records are:

    • Linked to the actual Milestone

    • Assigned a status like “Planned,” “Expected,” or “Received”

    • Monitored for completeness and inspection readiness

Limitation: This approach is more rigid and relies heavily on configuration templates. Changes or overrides are not easily scalable.


2. EDL Refactoring (Direct)

A faster, newer approach where the system bypasses the Expected Document Template layer and links the EDL items directly to Template Milestones. This is especially useful when leveraging Vault’s latest features for automation.

Flow:

  1. Template Milestone → directly relates to → the Expected Document types (No need to configure a lot of Template Expected Documents Lists)

  2. When a Milestone is created, Vault automatically generates:

    • The Expected Document List - based on the filing level

    • the child Expected Documents (EDL Items) directly linked to that Milestone

  3. These Expected documents:

    • Are created more efficiently and are easier to manage

    • Support Vault’s latest automation features and configurable logic

Advantage: Reduces admin overhead, improves performance, and is more compatible with modular configuration (e.g., Ad Hoc milestones, EDL Overrides, etc.)


Summary of Differences

Feature

Without EDL Refactoring

With EDL Refactoring

Link Template Milestone and Template Expected Document List

✅ Yes

❌ No

Configuration Overhead

High

Low

Flexibility

Limited

High

Automation Speed

Moderate

Fast

Best For

Stable, legacy templates

Agile, scalable setups


Benefits of the Milestones <-> EDLs in Clinical Vault


1. Centralized Timeline-Document Alignment

  • Benefit: Links operational milestones (e.g., Site Activation) with expected regulatory documents (e.g., IRB Approval) in a single model.

  • Helps:

    • eTMF: Ensures documents are expected and tracked exactly when they should be.

    • CTMS: Provides real-time visibility into operational status by milestone progress.

    • SSU: Aligns startup activities with required document submissions.


2. Automation of Document Expectations

  • Benefit: Auto-generates Expected Documents when milestones are triggered via lifecycle stages or story events.

  • Helps:

    • eTMF: Eliminates manual tracking of when and what documents are needed.

    • CTMS: Supports milestone-based progress and alerts.

    • SSU: Reduces startup delays with predefined document requirements per country/site.


3. Inspection Readiness by Design

  • Benefit: Every document is traceable to a milestone, with status tracking (e.g., Planned, Received).

  • Helps:

    • eTMF: Ensures complete, timely, and auditable documentation.

    • CTMS: Tracks operational compliance with GCP timelines.

    • SSU: Identifies missing documents preemptively for audit readiness.


4. Template Reuse & Regional Flexibility

  • Benefit: Supports global templates with local overrides via Milestone Sets and EDL logic.

  • Helps:

    • eTMF: Standardizes document expectations across studies and regions.

    • CTMS: Adapts country-specific milestone timelines.

    • SSU: Accelerates setup by reusing milestone/EDL templates for common scenarios.


5. Cross-Module Reporting & Oversight

  • Benefit: Enables unified reporting across milestones, documents, and lifecycle events.

  • Helps:

    • eTMF: Tracks document completeness by milestone across studies.

    • CTMS: Provides study-level, country-level, and site-level operational insights.

    • SSU: Supports real-time dashboards to monitor activation progress and bottlenecks.


What’s Next?

In upcoming articles, we’ll explore how this model supports:

  • eTMF Inspection Readiness with proactive document planning and milestone visibility.

  • Study Startup Acceleration, using milestone-driven document and task orchestration.

  • Country Intelligence, where milestone timelines vary by region and can be analyzed at scale.

  • CTMS Study Oversight, with real-time milestone progression and linked documentation.


Final Thoughts

Unlocking the Milestones and EDLs Object Model in Veeva Vault Clinical is the beginning; The Milestones and EDLs model is not just a configuration setup—it’s a strategy for modern clinical operations. By leveraging templates, lifecycle automation, and direct EDL Refactoring, sponsors and CROs can operate with greater agility, control, and audit readiness.


Stay tuned as we unpack the business value of this model across each key module in the Veeva Vault Clinical Suite.



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