Deleting Documents

This video provides a detailed instructional guide on the process of deleting documents within Veeva SiteVault, the eRegulatory and eISF (electronic Investigator Site File) system designed for clinical research sites. The primary context for document deletion is correcting errors, such as uploading duplicate files or documents in error, while maintaining strict adherence to regulatory requirements for document control and auditability. The tutorial distinguishes between two critical document states—the Draft state and the Approved/Steady state—as the deletion process and required user permissions vary significantly based on the document's lifecycle status.

The video first addresses deleting documents in the Draft state. For a document that has not yet been approved, the deletion process is straightforward: users click into the document, access the action menu, and select "Delete." This action immediately removes the document from the SiteVault library. A more nuanced scenario involves "up-versioned" documents (e.g., version 2.1) that are currently in the Draft state. In this case, users can navigate to the version history section and delete only the specific draft version. This action does not delete the entire document record but reverts the document back to its latest approved or "steady state" version, ensuring that the previously approved record remains intact and accessible. Both Site Administrators and general Site Staff are permitted to delete documents in the Draft state.

The process for deleting documents that have reached the Approved or Steady state is far more restrictive, reflecting the regulatory necessity of preserving official records. To delete a steady-state document, the user must possess the Site Administrator role. The administrator must click into the document, use the action menu, and select "Delete All Versions." Crucially, the system requires the administrator to choose a specific reason for deletion and add any necessary comments, creating a documented justification for the permanent removal. Once confirmed, the document is permanently removed from the main library. For compliance and auditing purposes, Veeva SiteVault maintains a comprehensive record of these actions. Site Administrators can access a dedicated "Deleted Document Records" report via the Reporting tab, which provides details on the document, the reason for deletion, and a copy of the full audit trail from the deleted document. This ensures that while the document is removed from the active library, a complete, auditable history of its existence and removal is preserved, a key requirement for GxP and 21 CFR Part 11 compliance.

Key Takeaways: • Document deletion procedures in Veeva SiteVault are strictly governed by the document's lifecycle state (Draft vs. Steady/Approved) and the user's role, reflecting critical regulatory control requirements for clinical trial documentation (eISF/eRegulatory). • Deleting a document in the Draft state is permissible for all Site Staff and Site Administrators and results in the immediate removal of the document from the library without requiring a formal justification. • When a document is "up-versioned" (e.g., a draft version 2.1 exists), deleting the specific draft version does not delete the entire document; instead, it reverts the document back to its last approved "steady state" version (e.g., version 2.0). • Deleting documents that have reached the Approved or Steady state is a highly restricted action, requiring the Site Administrator role to execute, emphasizing the need for elevated permissions when managing finalized, regulated content. • Permanent removal of an approved document requires the administrator to select "Delete All Versions," mandating the input of a specific reason for deletion and accompanying comments to satisfy audit trail requirements. • The system ensures regulatory compliance by retaining a complete audit trail of the deleted document, which includes details about the document, the reason for its deletion, and the full history of actions taken on it prior to removal. • Site Administrators can access this crucial compliance information via the Reporting tab by navigating to the "Deleted Document Records" report, which serves as the official record of removed regulated content. • The audit trail of deleted documents is accessible only to internal Site Administrators; external users (e.g., monitors or sponsors) do not have access to this specific report, maintaining internal control over site documentation processes. • The necessity of providing a documented reason for deleting approved documents highlights the importance of maintaining data integrity and accountability within clinical research operations, aligning with GxP principles.

Tools/Resources Mentioned:

• Veeva SiteVault
• Veeva SiteVault Free
• eBinder (Implied location where deleted document records are reported)

Key Concepts:

• Draft State: The initial phase of a document's lifecycle where it is still being authored or reviewed and has not yet been formally approved.
• Steady State (Approved State): The phase where a document has been formally reviewed, approved, and is considered the official, active version of the record.
• Up Versioning: The process of creating a new draft version of an already approved document (e.g., moving from version 2.0 to a draft of 2.1).
• Audit Trail: A chronological, unalterable record of all actions performed on a document, crucial for demonstrating regulatory compliance (e.g., 21 CFR Part 11).
• Site Administrator: A user role with elevated permissions necessary to perform critical, regulated actions such as permanently deleting approved documents.