Document Versioning

This video provides an in-depth exploration of document versioning within Veeva SiteVault, Veeva's eRegulatory and eISF system designed for clinical research sites. The presenter outlines the critical need for robust document versioning in a regulated environment, explaining how the system manages updates to ensure clarity, maintain an audit trail, and prevent confusion regarding the most current version of a document. The tutorial systematically demonstrates the practical steps involved in updating documents, distinguishing between those in a draft state and those already in a steady (approved or final) state.

The core mechanism discussed is the "stacking method," where all versions of a document are linked, clearly marking previous iterations as "superseded" while designating the latest approved version as "current approved" or "final." The video details the version numbering convention, where draft documents typically increment in 0.1 steps (e.g., 0.1, 0.2, 1.1, 1.2), and major approved versions are denoted by whole numbers (e.g., 1.0, 2.0). Specific scenarios necessitating versioning are highlighted, such as receiving updated ICF templates or protocols, making administrative changes like adding staff members, or updating monitor annotations that impact source or regulatory documents.

The tutorial progresses through two main workflows for uploading new document versions. First, for documents in the draft state, users learn to "check out" the document, make necessary edits (either directly or externally), and then "check back in" or "upload new version" to increment the draft version. Second, for documents already in a steady state (e.g., 1.0), the process involves selecting "create draft" from the action menu. This can then lead to either copying the file from the current version for internal edits or uploading an entirely new file. The video emphasizes using the workflow and state change menu to formally approve documents, transitioning them from a draft version (e.g., 0.2) to a major approved version (e.g., 1.0 or 2.0). Finally, it showcases the "version history" section and the "compare versions" feature, allowing users to track changes and access previous iterations, even after they have been superseded.

Key Takeaways:

• Purpose of Document Versioning: Document versioning in Veeva SiteVault is crucial for maintaining a clear, auditable history of changes, preventing confusion about the most current document, and ensuring regulatory compliance in clinical research settings.
• Superseded vs. Current Versions: The system automatically marks older versions as "superseded" when a new version is uploaded or approved, ensuring that only the "current approved" or "final" version is prominently displayed and used.
• Draft vs. Steady State Distinction: Documents exist in two primary states: "draft" (not yet approved) and "steady state" (current, approved, or final). Workflows for updating documents differ based on their current state.
• Version Numbering Conventions: Draft documents are typically noted by minor version increments (e.g., 0.1, 0.2, 1.1, 1.2), while approved documents receive major version numbers (e.g., 1.0, 2.0).
• Workflow for Draft Documents: To update a document in a draft state, users can "check out" the document, make edits, and then "check back in" or "upload new version" to increment the draft number (e.g., from 0.1 to 0.2).
• Workflow for Steady State Documents: For documents already approved, the process involves selecting "create draft" from the action menu. Users can then either "copy file from current version" for internal edits or "upload new file" if an entirely new document needs to replace the current one.
• Formal Approval Process: Moving a document from a draft state (e.g., 0.2) to a major approved version (e.g., 1.0) requires utilizing the "workflow and state change menu" to select the appropriate approval method.
• Automated Version History: Veeva SiteVault automatically populates a "version history" section under document information once a document has multiple versions, providing a comprehensive log of all changes.
• Compare Versions Feature: The system offers a "compare versions" functionality via the action menu, allowing users to easily review the specific changes made between different iterations of a document.
• Access to Previous Versions: Even after a document has been superseded, users can still access and view previous versions by clicking into them, though the system will clearly indicate that a newer steady-state version exists.
• Regulatory Compliance Support: The robust versioning capabilities are essential for managing critical regulatory and clinical trial documents like Informed Consent Form (ICF) templates, study protocols, and FDA Form 1572s, ensuring auditability and adherence to GxP and 21 CFR Part 11 requirements.
• Operational Efficiency: By standardizing document updates and providing clear version control, Veeva SiteVault helps clinical research sites streamline their eRegulatory and eISF processes, reducing manual errors and ensuring that all stakeholders are working with the most current information.

Tools/Resources Mentioned:

• Veeva SiteVault: An eRegulatory / eISF system specifically designed for clinical research sites.

Key Concepts:

• Document Versioning: The process of creating and managing multiple iterations of a document, tracking changes over time.
• Steady State: Refers to documents that are current, approved, or final within the system.
• Draft State: Refers to documents that are not yet approved and are still undergoing revisions.
• Superseded: The status given to older versions of a document once a newer version has been approved or uploaded, indicating they are no longer the current active version.
• eRegulatory / eISF: Electronic Regulatory / Electronic Investigator Site File systems, which manage essential documents for clinical trials digitally.
• Action Menu: A context-sensitive menu within Veeva SiteVault providing options like "check out," "check in," "upload new version," "create draft," and "compare versions."
• Workflow and State Change Menu: A system menu used to initiate and manage document approval processes, transitioning documents between different states (e.g., from draft to approved).

Examples/Case Studies:

• Updating ICF (Informed Consent Form) templates or study protocols.
• Making changes due to staff member additions.
• Updating monitor annotations that require a change to source or regulatory documents.
• Revising FDA Form 1572 (Statement of Investigator) to add a new sub-investigator.