Remote Monitoring in Clinical Trials - SiteTalks Webcast

This video provides an in-depth discussion on the rapid adoption and best practices of remote monitoring in clinical trials, primarily driven by the operational necessity imposed by the COVID-19 pandemic. Moderated by Bri Burks of Veeva Systems, the panel features leaders from diverse research sites—including Duke School of Medicine, Vanderbilt Coordinating Center, Javara (an integrated research organization), and Keystone Clinical Research—who share their immediate challenges, infrastructural advantages, and long-term strategic recommendations. The core purpose of the webcast is to create an informal platform for researchers to exchange ideas on practical ways to continue critical work when monitors cannot access files on-site.

The discussion begins by detailing the immediate impact of COVID-19, forcing sites like Duke and Vanderbilt to issue mandates blocking external monitors and quickly converting to remote monitoring protocols. Sites with existing infrastructure, such as Duke, were able to leverage pre-existing remote monitoring capabilities and streamline IRB approval processes for remote EMR access without extensive amendments. Conversely, sites like Keystone, which historically relied on paper-based systems (especially in niche areas like ophthalmology), faced significant challenges in transitioning staff and contracted physicians to electronic systems for source documentation and signatures. A central theme emerged: the pandemic is acting as a rapid accelerator for digital adoption, forcing the industry to overcome historical hesitation rooted in entrenched practices and vendor resistance.

The panelists emphasized that the shift to remote monitoring offers substantial long-term benefits beyond crisis management. These benefits include reduced travel costs and time for sponsors, decreased burnout and improved job satisfaction for CRAs (who are constantly traveling), and enhanced quality control for sites. Vanderbilt shared that their long-term adoption of remote monitoring since 2012 allowed them to identify data errors and implement changes earlier, often in near real-time, improving overall trial quality. The conversation culminated in actionable advice for sites, differentiating between short-term crisis management (using existing systems like encrypted email, HIPAA-compliant telehealth, or shared drives) and long-term strategic planning (implementing comprehensive digital strategies encompassing eRegulatory, eSource, and patient engagement tools). A key regulatory insight shared was the need for sites to meticulously check IRB approvals, clinical trial agreements, and patient consent forms to ensure PHI sharing via remote methods is compliant, especially in light of new FDA and MHRA guidance encouraging remote practices.

Detailed Key Takeaways

• Remote Monitoring is an Industry Accelerator: The COVID-19 crisis has forced the rapid adoption of remote monitoring, overcoming years of industry hesitation and entrenched paper-based practices. This momentum should be leveraged to drive permanent enterprise-level change, benefiting both sites and sponsors by potentially accelerating timelines and reducing costs.
• Immediate Crisis Action Plan: Sites must immediately assess their current electronic capabilities (e.g., encrypted email, HIPAA-compliant telehealth, shared drives) and identify what institutional policies and agreements (like EMR access forms) are needed to facilitate remote access for monitors, ensuring a consistent message across the research community.
• Long-Term Digital Strategy is Crucial: For sustained success, sites must develop a comprehensive technology strategy that integrates eRegulatory systems (eISF), eSource documentation, patient engagement tools, and internal communication platforms. This strategy should be planned over a 1, 3, and 5-year horizon rather than focusing solely on immediate fixes.
• Regulatory Compliance for PHI Sharing: Sharing Protected Health Information (PHI) remotely requires a meticulous, study-by-study regulatory check: verifying IRB application approvals, reviewing the PHI section of the Clinical Trial Agreement (CTA), and ensuring patient consent forms cover the method and scope of remote data access.
• Address CRA Burnout and Efficiency: Remote monitoring offers a significant opportunity to improve the quality of life for CRAs by reducing constant travel, potentially lowering turnover rates, and allowing them to focus on higher-value monitoring activities, which ultimately benefits site operations and data quality.
• Start with eRegulatory (eISF): For sites beginning their digital transformation, implementing an eRegulatory system is a practical starting point. Sites should look for solutions that fit their budget, including free or low-cost options, and avoid "analysis paralysis" by taking immediate action and iterating on the process later.
• Justify Budget Renegotiations: If remote monitoring increases site burden (e.g., time spent redacting documents or uploading to new systems), sites should confidently renegotiate study budgets with sponsors, providing detailed justification for the additional time and effort required, leveraging the current industry need for data continuity.
• Controlled EMR Access is a Site Decision: Granting remote access to the Electronic Medical Record (EMR/EHR) is entirely controlled by the site and its institutional privacy officer. Sites must be cautious about granting open-ended access that might expose sensitive, non-study-related patient data beyond what is covered by the study consent.
• Quality Improvement through Early Detection: Remote monitoring, especially when supported by robust eSource systems, enables earlier identification of data errors and protocol deviations, allowing sites to implement corrective actions in near real-time, leading to higher overall trial quality compared to traditional on-site cycles.
• Standardize Processes via SOPs: Sites should use this opportunity to update SOPs to reflect remote monitoring capabilities, ensuring that processes are standardized across all studies rather than treating remote monitoring as a "one-off" exception, which is unsustainable and increases compliance risk.
• Leverage Existing HIPAA-Compliant Systems: Before investing in new software, sites should check if their institution offers HIPAA-compliant versions of shared drives (like Box or Dropbox) or telehealth platforms, as these can be utilized immediately for secure document sharing and virtual patient visits.
• Proactive Sponsor Communication: Sites must proactively communicate their remote monitoring plan and capabilities to their sponsor and CRO partners, running through the study-specific regulatory checks (consent, CTA) together to ensure alignment and speed up the implementation process.

Tools/Resources Mentioned

• Veeva Systems: The channel and moderator are associated with Veeva, whose products support clinical trial operations and site solutions.
• Epic Health Connect: Mentioned as a system used by Vanderbilt to connect some EHR capability remotely.
• WebEx/Zoom: Used for virtual patient visits and internal team meetings, though security concerns regarding PHI recording were noted.
• Ver Trials: Mentioned as a specific, marketed solution for supporting remote telehealth visits for clinical trial patients.
• Box/Dropbox: Suggested as potential HIPAA-compliant shared drive solutions if already available institutionally.
• ACRP Nets Website: Mentioned as a community resource for sites to share best practices and advice.

Key Concepts

• eSource (Electronic Source Documentation): The practice of capturing clinical trial data directly into an electronic format, eliminating the need for paper charts and facilitating remote review.
• eRegulatory (eISF): Electronic Investigator Site File systems used to manage and share essential regulatory documents securely with sponsors and monitors.
• PHI (Protected Health Information): Health information protected under HIPAA and GDPR, requiring explicit consent and secure methods for remote sharing.
• Analysis Paralysis: The state of being unable to make a decision or start a project due to over-analyzing or seeking a perfect solution, a pitfall sites are warned to avoid when implementing digital systems.
• Sponsor Monitoring Agreement: The contractual agreement defining the terms, frequency, and methods of monitoring, which may need updating to explicitly allow for remote access.