Bulk Upload of Regulatory Documents Using the Document Inbox

This instructional video details the process for clinical research sites to efficiently upload and classify regulatory documents in bulk using the Document Inbox feature within Veeva SiteVault Free. The primary goal of this functionality is to streamline preparation for critical milestones, such as Site Initiation Visits (SIVs) or upcoming remote monitoring visits, by allowing users to quickly ingest large volumes of required documentation into the electronic regulatory binder (e-binding) system. The process emphasizes efficiency through bulk actions, allowing users to drag and drop up to 250 regulatory documents simultaneously from their local file explorer into the SiteVault platform.

The workflow is structured around two main phases: uploading and classification. After successfully uploading documents, which are initially placed in the user's Document Inbox view, users are guided on how to apply bulk metadata. This is particularly useful if a batch of documents shares common attributes, such as being associated with the same study, organization, or person. The video cautions that while bulk upload is efficient for regulatory files, it is generally not considered best practice for source documents. Once uploaded, if the files do not immediately appear, users are advised to refresh the view by navigating to another library view and returning to the inbox.

The classification phase focuses on assigning the correct document type and completing required metadata fields. For documents of the same type, users can select the batch and use the "Complete" action to apply the document type simultaneously. If the documents require identical information (e.g., the same study ID or date), users can complete the fields once and use the "Apply" function to propagate that information across all selected documents. If documents within the batch require differing information, the user must process them individually, using an arrow function that automatically saves the current document and moves to the next one requiring completion. A green checkmark confirms that all required fields have been filled, and the final step is saving the changes. It is explicitly noted that all documents uploaded via the Document Inbox are initially saved in the "Draft State," even after classification, and require a subsequent approval step to be filed to the e-binding.

Key Takeaways: • Optimizing for Clinical Milestones: The Document Inbox feature in Veeva SiteVault Free is designed to expedite the preparation of regulatory documentation required for critical clinical research events, such as Site Initiation Visits (SIVs) and remote monitoring visits, improving site efficiency. • Bulk Upload Capacity and Caveats: Users can upload up to 250 regulatory documents simultaneously using the drag-and-drop functionality; however, this method is explicitly discouraged for the ingestion of sensitive source documents, suggesting alternative, more controlled methods should be used for those files. • Initial Document State: All documents uploaded through the Document Inbox are placed in the "Draft State," regardless of whether they have been fully classified with metadata. They require a separate approval workflow to be officially filed to the e-binding and become active within the system. • Leveraging Bulk Field Application: To maximize efficiency, users should utilize the bulk field application feature when uploading documents that share common metadata, such as being associated with the same study, organization, or specific personnel. • Classification Workflow: The classification process involves selecting the document type and completing required fields. Green check marks serve as visual confirmation that all mandatory metadata fields have been addressed before saving. • Handling Heterogeneous Batches: If a bulk upload contains documents requiring different metadata inputs, the system allows for individual completion. Users can leverage the automated arrow function to save the current document's information and seamlessly advance to the next document in the queue. • Accessing the Inbox Assistant: The video mentions the "Inbox Assistant" and the inbox icon as the means to manage and work on any remaining documents that still require classification or completion within the user's inbox view. • Refreshing the View: If newly uploaded files do not immediately appear in the Document Inbox, the suggested troubleshooting step is to navigate to another library view and then click back into the inbox to force a refresh and display the documents.

Tools/Resources Mentioned:

• Veeva SiteVault Free
• Document Inbox (Veeva SiteVault feature)
• Inbox Assistant (Veeva SiteVault feature)
• e-binding (Electronic Regulatory Binder)

Key Concepts:

• Regulatory Documents: Essential documentation required for clinical trials, subject to regulatory oversight (e.g., protocols, consent forms, delegation logs).
• eRegulatory / eISF: Electronic systems used by clinical research sites to manage the Investigator Site File (ISF) and other regulatory documentation digitally, ensuring compliance and accessibility.
• SIV (Site Initiation Visit): A critical meeting held before a clinical trial begins at a site, ensuring all documentation and procedures are in place.
• Remote Monitoring Visit: Oversight activities conducted by sponsors or CROs to ensure trial integrity and compliance, often requiring access to site documentation.
• Draft State: The initial status of a document in Veeva SiteVault, indicating it has been uploaded and potentially classified but has not yet undergone the final approval process required for official filing.