Enhancing Compliance and Identifying Risk through Centralized Monitoring

Stuart Cotter
Director of Product Success, Forte
April 26th, 2018

Effective monitoring is paramount for both sponsors and research institutions to conduct high-quality studies and to ensure human subjects protection. In recent years, the industry has moved towards greater use of centralized, remote monitoring practices. These practices have the potential to offer more cost-efficient and effective results by providing “real-time” monitoring.

Combining a well-designed, clear protocol with a strategic monitoring plan that utilizes trained resources, technology and statistical monitoring techniques makes it much easier for monitors to quickly identify problem protocols and/or sites. By recognizing and addressing these problems quickly, centralized monitoring can help reduce regulatory risks, data errors and protocol deviations. Per the FDA, a key aspect of the monitoring plan is that activities should focus on the specific subject and data integrity risks of the trial. In addition to identifying risk, the assessment should specifically identify the impact of potential missteps, and how these could be detected as early as possible.

Consistent, compliant trial data

Another key step toward enabling effective centralized monitoring is the research institution and sponsor working together to provide access to trial data in a consistent and efficient format. In addition to the underlining infrastructure of capturing and storing clinical documentation, the accessibility of this information in a 21 CRF Part 11-compliant manner is extremely beneficial, and mandatory for electronic records. This ensures remote monitoring goals are not inhibited by misunderstanding of data or technical errors in the monitoring review. As more studies utilize centralized monitoring, adherence to these standards will be vital to ensure effective practices and mitigate risk.

Enabling regulatory staff and monitors

In addition, research institutions need to confidently understand and control what information is being shared in a remote monitoring session. Allowing privileged access to the clinical documentation achieves the goal of enabling high-quality studies and ensuring human subject protection, while also creating efficiencies at both the sponsor and research institution.

Utilizing an eRegulatory system, such as Forte eReg, can simplify regulatory monitoring for researchers and sponsors by allowing regulatory managers to easily dictate the documentation that a monitor can view, as well as the start and stop points for access. For research institutions, this ensures monitoring is done in a compliant and efficient manner, while minimizing (or altogether eliminating) the day-to-day impact on their research staff. For monitors, this provides a quick, complete view into the trial, promoting more effective monitoring and safer, more efficient studies.

Learn more about how Forte eReg can help enable effective centralized monitoring and improve workflows across your organization.

Join our free webinar

Register for our upcoming webinar Understanding, Achieving and Maintaining 21 CFR Part 11 Compliance to learn more about 21 CFR Part 11 compliance and the roles both organizations and vendors play during the validation process.