Vault Study Startup Feasibility Surveys

This video provides a detailed demonstration of the Veeva Vault Study Startup application's feasibility feature set, specifically focusing on how it streamlines the process of distributing, receiving, and tracking surveys from investigator sites. The primary goal is to enhance the efficiency of identifying suitable clinical trial sites more rapidly and seamlessly connect this selection process to the subsequent site activation phase. A key innovation highlighted is the system's ability to engage external contacts—individuals who are not full users within the sponsor's clinical vault—to complete these crucial surveys securely.

The demonstration walks through the entire workflow from the perspective of a feasibility lead. It begins with a view of prospective sites in a "candidate" state within a specific study country. Once a site is deemed ready for qualification, an action is taken, moving the site to an "invited" state. This triggers the automatic dispatch of an initial outreach survey to identified contacts within that organization. The video details how to manage and update these contact lists, emphasizing the importance of email addresses and survey responder types. Upon completion of the outreach survey, if interest is expressed, a link to the more comprehensive "full feasibility survey" is automatically sent.

From the site's perspective, the video showcases the user-friendly interface for completing surveys within a highly secure, dedicated section of the clinical vault. Features like auto-saving responses, conditional fields (where selecting one option reveals additional questions), free comment sections, and the ability for sites to upload attachments (e.g., CVs, medical licenses) are demonstrated. Back on the sponsor side, the system tracks the survey status, identifies "fast track" sites based on prior experience, and automatically calculates a "feasibility score" upon survey completion.

The video concludes by illustrating how sponsor users can review survey responses either directly or via integrated reports. Workflow actions are available based on specific conditions, allowing for dynamic progression. Ultimately, when ready, the action to select a site can be taken, which then automatically generates a full set of startup milestones. The entire process, from initial outreach to final site selection and milestone generation, can be tracked at a granular level and displayed graphically within a comprehensive feasibility dashboard, offering real-time insights into progress and bottlenecks.

Key Takeaways:

• Streamlined Site Selection and Activation: Vault Study Startup significantly improves the efficiency of finding the right investigator sites by automating the survey process and seamlessly connecting site selection to activation, reducing manual effort and accelerating study startup timelines.
• Secure External User Engagement: The platform allows non-clinical vault users (site contacts) to securely access and complete surveys through unique, configurable links, eliminating the need for full user licenses while maintaining data integrity and security.
• Automated Multi-Stage Survey Workflow: The system automates the distribution of both initial "outreach surveys" and subsequent "full feasibility surveys" based on site responses and qualification progress, ensuring timely and relevant information gathering.
• Configurable Communications and Surveys: Outreach email notifications and the surveys themselves are fully configurable, enabling sponsors to tailor content, questions, and branding to specific study requirements and organizational standards.
• Enhanced Data Capture Features: Surveys support advanced functionalities such as auto-saving responses to prevent data loss, conditional logic (e.g., revealing sub-questions based on previous answers), free-text comments, and the ability to upload attachments like CVs or medical licenses, ensuring comprehensive data collection.
• Data-Driven Site Qualification: The system automatically calculates a "feasibility score" upon survey completion, providing an objective metric for site evaluation. It also identifies "fast track" sites based on prior experience, allowing for differentiated qualification paths and potentially expedited processes.
• Comprehensive Sponsor-Side Tracking and Review: Sponsor users have a full view of qualification details, including survey status, completion dates, qualification notes, and the calculated feasibility score. They can review survey responses directly within the system or via integrated reports for detailed analysis.
• Granular Process Tracking and Visualization: The entire study startup process, from candidate identification through site selection and milestone generation, is tracked at a granular level and visualized through a dedicated feasibility dashboard, offering real-time insights into progress and potential bottlenecks.
• Automated Milestone Generation: Upon final site selection, the system automatically generates a full set of startup milestones, ensuring consistency, reducing administrative overhead, and accelerating the initiation of the clinical trial.
• Importance of Contact Management: Accurate and up-to-date site contact information, including correct email addresses and defined survey responder types, is crucial for the effective distribution and tracking of feasibility surveys and overall communication.

Tools/Resources Mentioned:

• Vault Study Startup: The core application demonstrated, part of the Veeva Vault suite, designed to manage clinical study startup processes.
• Clinical Vault: The broader Veeva platform within which Vault Study Startup operates, providing a secure, compliant environment for managing clinical operations and data.
• Feasibility Dashboard: A visualization tool within Vault Study Startup that provides graphical representations and granular tracking of the feasibility process, offering real-time insights.

Key Concepts:

• Feasibility Surveys: Questionnaires distributed to potential investigator sites to assess their capabilities, resources, and interest in participating in a clinical trial. These are critical for initial site evaluation.
• Study Startup: The initial phase of a clinical trial, encompassing all activities from protocol finalization to site activation and first patient enrollment. Efficiency in this phase is crucial for overall trial timelines.
• Site Activation: The process of getting an investigator site fully ready to enroll patients in a clinical trial, including obtaining regulatory approvals, executing contracts, and providing necessary training and supplies.
• Investigator Sites: Clinical research sites or institutions where clinical trials are conducted, typically led by a principal investigator.
• Clinical Vault: A secure, cloud-based content management and application suite by Veeva Systems, specifically designed for managing clinical operations and data in a regulated environment.
• Sponsor: The individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial.
• Site Contact: An individual at an investigator site responsible for receiving and responding to communications and surveys related to clinical trial participation.
• Fast Track Site: A designation for an investigator site with which the sponsor has significant prior positive experience, potentially allowing for an expedited qualification process due to established trust and familiarity.
• Feasibility Score: An automatically calculated metric that quantifies a site's suitability or readiness based on their responses to feasibility surveys, providing an objective basis for comparison and decision-making.