Flexible, Efficient Oversight with Data Integrity and Real-Time Communication
The COVID-19 pandemic forced study teams to adapt, improvise and overcome as they faced the need to monitor clinical trials, sites and patients from remote locations. Moving forward, we see remote monitoring as part of a successful strategy for managing clinical studies. In this posting, we share “lessons learned” and best practices.
Remote Monitoring Benefits
The advantages of effective remote site monitoring include:
- Efficiency – Tasks that can be completed off-site reduce travel costs and time. Once on-site, clinical research associates (CRAs) can quickly focus on activities that can only be completed in-person.
- Data integrity – CRAs can conduct more frequent reviews of data and mitigate any issues before they become systemic problems.
- Readiness – With remote monitoring incorporated as a standard, organizations are ready for the next business continuity event and prepared to address the industry trends such as decentralized trials.
- Effective team communication – The technology behind remote monitoring delivers fast, real-time oversight across functional areas, including dashboards and system messaging among sites, sponsors and Covance.
Central Monitoring Factors
There are two essential considerations for remote study oversight:
Critical data and processes – Which data can be reviewed remotely? Are there any processes or data that must be reviewed in person? How frequently? What are the sources of data, and how will they be integrated? Combining all data from all sources allows for comparison across sites and studies in a portfolio. Remote monitors then easily review the outliers and identify areas of risk or inconsistency vital to a study or therapeutic area.
Processes – Identifying risks and issues is the first step; the risks and issues can then be appropriately actioned. Communication pathways between remote monitoring, central monitoring and on-site monitoring must be established across functions. All actions should be tracked in a central repository for follow-up, with a site contact provided, to ensure that issues are correctly closed without duplication of effort. The Xcellerate® risk and issue management (RIM) tool presents all issues and actions in one location.
There are several actions required to move from traditional monitoring to remote monitoring for a clinical study:
- Revisit risk assessment – Ask the study team to redefine/confirm study goals, reevaluate risks and address mitigations.
- Redefine critical data and processes – Identify factors for review via remote monitoring vs. central monitoring to avoid gaps affecting risk or quality.
- Update documentation – Changes in monitoring can be flags for inspections and audits; have a rationale reflecting risk assessment when building a monitoring strategy.
- Adopt central monitoring – Avoid silos while bringing together site and central monitoring strategies, considering risks in aggregate.
Study teams can conduct remote monitoring via approved platforms or web conference – with or without source data verification (SDV) or source data review (SDR). SDV and SDR may be conducted remotely where sites have capabilities for secure remote access to source documents and data – if remote access is allowed, according to applicable local regulations and site policies. Other remote visit activities include data review focusing on project-specific critical data, reviewing the investigational product (IP), essential documents and communication with site staff.
Permission and Compliance
Before moving forward with a remote monitoring strategy – especially involving remote SDV – confirm appropriate country permissions; a single monitoring strategy may not cover all locations. Covance offers a SiteIntelAct database that contains remote monitoring capabilities by country, with required approvals.
Only conduct remote SDV/SDR using approved remote SDV methods once the following criteria are met:
- Country regulatory and privacy law compliance
- Sponsor agreement
- Site infrastructure confirmed as “fit for use” according to SOPs
- Site-level data protection authority acceptance
- Ethics committee approval/notification
- Principal or site investigator acceptance and support
- Patient consent allowing personal data access off-site
Preferred remote SDV methodologies include:
Electronic medical records (EMRs) – direct, full and complete access to trial participants’ medical records via site EMRs. Before use, the CRA must assess these according to SOPs, with site staff providing instruction and guidance. This is the most reliable, secure and efficient method for accessing source data in real-time. Some EMRs provide only access to partial source data, so the CRA must document which source can be reviewed remotely vs. on-site. Clear and comprehensive policies are required at the site level to allow direct, remote CRA access to EMRs.
Source document sharing platforms – access to trial participants’ certified medical records via a controlled electronic document sharing platform where CRAs can access subject data. As with EMRs, the CRA and project team must assess these before use, ensuring the systems meet industry standards for privacy and data protection. Be aware that these systems can place an additional burden on the site personnel to scan and upload records to the platform. Consider the certified copy processes and the impact on SDV methodologies.
Web conferencing technology may be used in some cases when using EMR or source document sharing platforms is not possible. However, sharing source records via transmission media should be avoided unless necessary to address critical patient safety issues.
When implementing a remote monitoring strategy in response to an unplanned situation or crisis, focus on monitoring activities pertaining to subject safety while limiting the impact to site staff working at a limited capacity. Priority tasks include serious adverse event (SAE) review and follow-up, consent review, IP conditions and storage, plus SDV/SDR of primary endpoint data.
The pandemic required study teams to monitor projects, sites and patients remotely. “Lessons learned” have evolved into best practices for a successful monitoring strategy, as teams embrace benefits including flexibility, efficiency, data integrity and real-time communication. Concerned about managing risk for clinical studies?