BEST PRACTICES: COMPlETENESS PLANNING AND TRACKING - Jim Horstmann & Brian Bialkowski

Sep 12, 2026

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Best Practices session content for completeness planning and tracking in Veeva Vault eTMF, presented by Jim Horstmann and Brian Bialkowski from Veeva. Covers what must be filed, how Expected Document Lists (EDLs) and their items map to library documents, and when documents should be filed using milestones across the study lifecycle. Provides guidance on achieving “good” completeness through having a formal plan, tracking data and events affecting expected documentation, and leveraging system functionality for accurate, efficient workflows including EDL automation and handling unplanned study events.

LanguageEnglish

CategoryPresentations

FormatPDF

Pages18

Reading Time6 min

AccessFree to download

Completeness Overview in Vault eTMF

What should be filed

Expected Document Lists (EDLs) and items

What is filed

When it should be filed by

Milestones and associations

What Does Good Look Like in Vault eTMF?

Completeness plan and process

Track data and events

Leverage system functionality

General Completeness Setup in Vault eTMF

TMF Index and document types

Configure EDL template and expected documents

Define milestone types

Create milestones across the study lifecycle

Completeness Setup – Study Events

Track unplanned study events

Use Ad Hoc Events, Site Personnel, Organizations

Feature Highlight – EDL Automation

Site Personnel and Organization automation

BEST PRACTICES: COMPLETENESS PLANNING AND TRACKING Jim Horstmann & Brian Bialkowski Veeva Vault Product Management Session Format Overview Veeva Best Practices 15 Minutes Q&A 15 Minutes Group Discussion 20 Minutes Copyright © Veeva Systems 2024 2 Veeva Best Practices Completeness Overview in Vault eTMF What should be filed Expected Document Lists (EDLs) and items What is filed Documents in the library, matched to the corresponding Expected Document item When it should be filed by Milestones, within which Expected Documents and their matched documents are associated Copyright © Veeva Systems 2022 4 What Does Good Look Like in Vault eTMF? 1 Have a completeness plan and process Track data and events 2 that affect expected documentation in the system 3 Leverage system functionality to make the process as accurate and efficient as possible Copyright © Veeva Systems 2022 5 General Completeness Setup in Vault eTMF 1~~ 2 3 4 5 ~~ Review TMF Index Identify which document types are expected and their associated milestones Configure EDL Template which will be associated with the study Define expected documents within the EDL template Define milestone types to indicate when each document is expected to be filed in the TMF New milestones created as the study moves through its lifecycle (e.g., the milestone for study close will be created once the study moves to the closing state) Copyright © Veeva Systems 2024 6 Completeness Setup – Study Events Establish a process to track unplanned study events (e.g., protocol amendments) Then leverage: • Ad Hoc Events • Site Personnel • Organizations Copyright © Veeva Systems 2024 7 Feature Highlight – EDL Automation Site Personnel and Organization – EDL Automation Perform with conditions Study Team Role Includes If Copyright © Veeva Systems 2024 8 Feature Highlight – EDL Automation Site Personnel and Organization – EDL Automation workspace" Perform with conditions Study Team Role Includes If perform actions Create Expected Documents Feature Highlight – EDL Automation Site Personnel and Organization – EDL Automation

Sep 12, 2026

Upload by Melati