Remote Monitoring for Sponsors and CROs

This demonstration provides a detailed walkthrough of the remote monitoring workflow for sponsors and Contract Research Organizations (CROs) utilizing Veeva SiteVault Free, an eRegulatory system designed for clinical research sites. The primary purpose is to illustrate how monitors can efficiently perform Source Data Review (SDR) and Source Data Verification (SDV) remotely, streamlining the traditionally manual process of clinical trial oversight while ensuring compliance. The presentation focuses on the monitor’s perspective, highlighting the platform’s features for task management, document interaction, and reporting.

The workflow begins with the site sending documents for review, triggering immediate email and homepage notifications for the assigned monitor. Upon logging into SiteVault, the monitor accepts the review task, which opens an envelope of documents. A key feature is the intuitive left-hand navigation panel, allowing the monitor to quickly move between documents within the task. The process involves active review, where the monitor can resolve existing site annotations or create new ones. For instance, if the monitor identifies a discrepancy—such as a mismatch between the visit date on the source document and the data entered into the Electronic Data Capture (EDC) system—they can highlight the specific data point and tag the site with an annotation detailing the issue.

After reviewing each document, the monitor assigns a verdict, choosing from options like "resolved comment," "issues annotated and returned to the site," "no review required" (supporting risk-based monitoring strategies), or "no issues." Once the task is complete, the monitor receives a summary of all verdicts provided across the document set. Beyond individual task completion, the platform emphasizes high-level oversight through integrated reports and dashboards. Monitors can filter these dashboards by study to view the overall Source Document Review status and, critically, drill down into specific safety-related issues. The system allows monitors to easily identify documents flagged by the site as surrounding a protocol deviation or an Adverse Event (AE), enabling focused attention on high-risk data points.

The final segment of the demonstration covers essential document management capabilities, particularly the integration with the Electronic Trial Master File (eTMF). The monitor can navigate the SiteVault library, which features Optical Character Recognition (OCR) functionality, enabling searches within the content of documents rather than just metadata. This is demonstrated by searching for a sub-investigator’s CV using a keyword like "Yale," quickly retrieving the necessary document. Monitors can add required documents (like CVs or source documents) to a digital "cart" and then download them in bulk. This download function facilitates the seamless transfer of verified, compliant documents out of SiteVault and into the sponsor’s eTMF system, ensuring the TMF remains current and complete.

Key Takeaways: • Streamlined Remote Monitoring Workflow: Veeva SiteVault Free centralizes the SDR/SDV process, initiating review via automated notifications (email and homepage) and providing a structured interface for monitors to accept and manage document review tasks efficiently. • Real-Time Discrepancy Flagging: Monitors can annotate specific data points directly on the source documents and tag the site immediately when discrepancies are found, such as mismatches between the source document data and the EDC system entry, accelerating query resolution. • Verdict-Based Task Completion: The system requires monitors to assign a specific verdict to each document ("issues annotated," "no issues," "no review required"), creating a clear audit trail and supporting risk-based monitoring strategies by allowing monitors to bypass full verification on low-risk documents. • Centralized Reporting for Oversight: Dashboards provide a high-level view of the overall source document review status per study, allowing sponsors and CROs to track progress and identify bottlenecks across multiple sites. • Risk-Based Monitoring Focus: The platform enables monitors to filter reports specifically for documents related to critical safety events, such as Adverse Events (AEs) or protocol deviations, ensuring immediate attention is paid to high-risk data elements. • OCR-Powered Document Retrieval: The library utilizes Optical Character Recognition (OCR) capability, allowing users to search within the actual content of documents (e.g., searching for a university name on a CV), significantly improving the speed and accuracy of locating specific compliance records. • Seamless eTMF Integration: The "cart" feature allows monitors to batch select and download verified source documents and essential regulatory documents (like CVs), facilitating rapid transfer and integration into the sponsor’s Electronic Trial Master File (eTMF) system. • Audit Trail and Compliance: By managing the entire review and verification process within a validated system like SiteVault, the platform inherently supports regulatory compliance by maintaining a clear, time-stamped record of all review actions, annotations, and final verdicts.

Tools/Resources Mentioned:

• Veeva SiteVault Free (eRegulatory system for clinical research sites)
• Electronic Data Capture (EDC)
• Electronic Trial Master File (eTMF)

Key Concepts:

• Source Data Review (SDR): The process of reviewing source documents to ensure the data is accurate, complete, and consistent with the protocol and regulatory requirements.
• Source Data Verification (SDV): The process of comparing source documents against the data entered into the EDC system to confirm accuracy.
• Optical Character Recognition (OCR): Technology used to enable text searchability within images or scanned documents, allowing the system to index and retrieve documents based on their content.
• Protocol Deviation: An instance where the conduct of a clinical trial deviates from the approved protocol.
• Adverse Event (AE): Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product.