Benefits and other important things about remote monitoring
Remote monitoring in clinical trials cannot completely replace on-site monitoring, but its implementation has demonstrated benefits in terms of efficiency, data quality, cost, and safety, making it a valuable tool in modern clinical research.
Both approaches (on-site and off-site) are often used in a complementary manner to ensure the integrity and quality of data in clinical studies.
Here are some interesting facts, questions and answers about remote monitoring, and why it is a safe and quality tool for cost-effective collection of clinical data.
What is remote monitoring?
Consist of an off-site assessment conducted by the monitor away from where the clinical study is being carried out.
How to perform remote monitoring?
- Data management, remote monitor or clinical research associates (CRAs) staff review electronic data capture (EDC) from central or remote location to pinpoint critical study visit discrepancies and trends.
- 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.
- Email/telephone/videoconferencing are tools to discuss discrepancies, retraining or corrective actions.
- Document findings via query EDC open action items in the next report if required.
Benefits of remote monitoring
- Efficiency: Tasks that can be completed off-site, reducing travel costs and time.
- Focus: 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 independent of the time of the site and its staff.
- Reports: Pre-defined quality systems checks are built into the system flagging certain data if it appears incorrect.
- 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: technology behind remote monitoring delivers fast, real-time oversight across functional areas, including dashboards and system messaging among sites, sponsors and Contract Research Organization (CRO).