27 - From Oversight to On-Site Support: Piloting the CareLink Workflow Through Embedded Monitoring

Background:  Site monitoring is a regulatory requirement often viewed as punitive, but it can be a powerful collaboration tool within Human Research Protection Programs. At one SIREN site, we piloted a real-time screening tool alongside a supportive monitor-site partnership to demonstrate how embedded monitoring can strengthen oversight and enhance program implementation.

Program

Description:  To reduce the burden of delayed, labor-intensive data pulls during active screening, this institution piloted CareLink, a real-time alert system designed to flag potentially eligible ICECAP participants. The SIREN-assigned monitor partnered with the site team to implement and refine this new workflow in a live trial setting. Rather than acting as an external reviewer, the monitor was embedded in the process, offering support throughout the rollout. Together, the team: (1) Assessed the CareLink alert’s clarity and utility for real-time decision-making. (2) Integrated alerts into existing pre-consent and screening workflows (3) Co-developed documentation tools to track alerts and enrollment outcomes (4) Held regular, informal check-ins to troubleshoot and refine the process. This embedded, collaborative approach enabled continuous feedback, built trust, and reframed monitoring as a mechanism for shared learning. It empowered the site to surface challenges and co-design solutions, showing how HRPP operations can evolve to support innovation through partnership-based oversight.

Program

Assessment:  The combined implementation of CareLink and embedded monitoring led to several observed benefits. The remote system helped the site monitor move away from time-intensive EMR reviews, streamlining screening without sacrificing accuracy. Simultaneously, the monitor’s consistent presence allowed for quick-turn process refinements, QA tracking, and integration troubleshooting. Team members reported that the monitor’s familiarity with site flow improved communication and built trust. Coordinators described feeling “backed up, not boxed in,” and emphasized how the monitoring relationship made it easier to share obstacles and co-design solutions. Together, the technology and relationship fostered mutual accountability and flexible problem-solving. Informal feedback suggested that this partnership-based model made both the innovation and oversight feel more efficient, less burdensome, and better aligned with trial needs. Although the pilot focused on a single site, the combined effect of tool and relationship suggests a replicable approach to strengthening HRPP functions. Embedding monitoring into implementation efforts allowed oversight to evolve from a compliance checkpoint into an integrated support mechanism for ethically and operationally sound research conduct.

Limitations: This pilot was limited to one site-monitor pair and focused on a single screening tool within one trial. Observations were based on informal feedback and process improvements rather than pre/post quantitative data. Institutional constraints, such as IRB documentation requirements and existing workflow limitations, affected implementation. While results may not generalize, they offer valuable insights into the synergistic potential of pairing embedded monitoring with innovation to improve HRPP operational effectiveness.

Discussion:  This pilot illustrates how innovation and oversight can reinforce one another within the HRPP framework. By combining the launch of a real-time alert system with an embedded, collaborative monitoring model, the site demonstrated smoother implementation, stronger engagement, and more responsive quality oversight. Institutions exploring new workflows, especially in high-pressure or emergency research settings, may benefit from pairing technical tools with relationship-centered monitoring strategies. Embedding the monitor as a partner helped bridge gaps between innovation and compliance. This model offers a scalable, practical approach for HRPPs seeking to modernize monitoring while preserving regulatory integrity and participant protection.