Starting a Training or Read and Understood Workflow

This video provides a practical demonstration of how to initiate a "Training or Read and Understood" workflow within Veeva SiteVault Free, an eRegulatory and electronic Investigator Site File (eISF) system designed for clinical research sites. The primary purpose of this feature is to electronically distribute essential documents, such as training materials or critical correspondence, and confirm that required study personnel have reviewed and acknowledged the content. This functionality is crucial for maintaining audit-ready documentation and ensuring regulatory compliance across clinical operations, particularly concerning GxP and personnel training requirements.

The process begins by confirming that the document intended for distribution is in the "steady state," meaning it has been formally approved and is ready for use or dissemination. To initiate the workflow, users access the "Workflow or State Change" menu and select the "Send for Training" option. A key constraint of the system is that only users who are actively assigned to the specific study associated with the document are available as potential recipients. This ensures controlled access and proper documentation of training within the study team structure.

Recipients can be selected either individually or as a group using the "Study Team" option, which automatically includes all assigned users. After selecting the necessary personnel, the user must define a due date for the completion of the task. Upon clicking "Start," the selected recipients are immediately notified via email and receive a corresponding task on their Veeva SiteVault homepage. This automated notification system streamlines the compliance process and provides an immediate electronic audit trail of the distribution.

Furthermore, the video highlights the management capabilities available once the workflow is active. Users can utilize the "timeline view" to actively manage the task, allowing for necessary modifications such as adding new participants who may join the study later, adjusting the due date if circumstances change, or canceling the task entirely if the document or training requirement is superseded. This administrative flexibility is essential for dynamic clinical trial environments where personnel and documentation requirements frequently evolve, all while maintaining a verifiable record of training completion.

Key Takeaways:

• Regulatory Documentation Necessity: The "Training or Read and Understood" workflow is a core mechanism for meeting regulatory requirements (e.g., 21 CFR Part 11, GxP) by providing an electronic, auditable confirmation that study personnel have reviewed and acknowledged critical study documents, such as SOPs or protocol amendments.
• Prerequisite Document State: Documents must be in the "steady state" and considered approved before they can be sent out for training or acknowledgment, reinforcing the importance of proper document lifecycle management within the eISF system.
• Targeted Recipient Selection: The system enforces strict access control, limiting recipient selection only to users who are formally assigned to the specific study, ensuring that training tasks are correctly distributed and documented within the defined study team structure.
• Group vs. Individual Distribution: Users have the flexibility to select the entire study team simultaneously using the "Study Team" group option, which is efficient for mandatory site-wide training, or to select individual team members for targeted training needs.
• Automated Task Notification: Upon workflow initiation, recipients receive immediate email notifications and a corresponding task on their Veeva SiteVault homepage, minimizing delays and ensuring prompt awareness of required training completion.
• Importance of Due Dates: Setting a specific due date is mandatory for the workflow, establishing clear expectations for timely completion and providing the site administrator with a metric for tracking compliance adherence.
• Active Task Management via Timeline View: The timeline view provides administrative control, allowing the initiator to modify the active workflow by adding new participants (critical for onboarding new staff), changing the due date, or canceling the task if the training becomes obsolete.
• Resource for Document Eligibility: The video directs users to the "Document Types Reference Spreadsheet" in the Veeva help section, which serves as a crucial resource for determining which specific document types are eligible to be sent through the training workflow.

Tools/Resources Mentioned:

• Veeva SiteVault Free: The specific eRegulatory / eISF platform where the workflow is executed.
• Document Types Reference Spreadsheet: An external resource provided by Veeva to clarify which documents can be sent for training.

Key Concepts:

• Read and Understood Workflow: A formal, electronic process used in regulated environments to confirm that personnel have reviewed and acknowledged critical documentation, serving as a key component of the audit trail.
• Steady State: The formal status of a document within the Veeva Vault system indicating that it has completed the approval process and is ready for use, distribution, or implementation.
• eRegulatory / eISF: Electronic systems used by clinical research sites to manage regulatory documents and the Investigator Site File, replacing paper-based processes to enhance efficiency and compliance.