What are monitoring and centralised monitoring and how do they differ from remote monitoring?
Monitoring of a clinical trial is an essential requirement of GCP and ISO 14155 and is the responsibility of the trial sponsor. The purpose of monitoring is to verify that the rights and well-being of trial participants are protected, to confirm that trial data are accurate, complete, and verifiable and that the trial is being conducted according to the protocol, Good Clinical Practice, and applicable regulatory requirements.
Historically, monitoring has always been conducted on-site where the monitor reviews source records at the hospital (source records may be medical records, pathology results, or data collected by a researcher in paper or electronic format) and checks this data against the trial data collected in the study database. The study database is where data are extracted for final analysis and reporting to the regulatory authorities. Monitoring also involves the review of patient safety, how well the researchers are following the study protocol, and checks on how the investigational product is being managed at the research site.
Over the past few years, a new type of monitoring, called centralized monitoring, has become very popular, and centralized monitoring involves a remote evaluation of data usually performed by data managers or biostatisticians. Centralized monitoring can be used to identify missing or inconsistent data, examine data trends, identify significant errors in data collection and reporting across different research sites, and potential data manipulation.
Remote monitoring is the monitoring of a trial that is not done as an on-site visit. Remote monitoring can therefore be completed at a monitor’s office or home using a laptop to review data and teleconference portals such as Zoom to communicate with site staff.
With the outbreak of COVID and restrictions posed by lockdowns, sponsors and research sites have had to pivot from conventional methods of monitoring to ensure adequate monitoring of clinical trials. Centralised monitoring has its benefits however certain aspects of monitoring just cannot be performed via centralised monitoring alone.
Remote monitoring can be effectively used during lockdown where sites have restrictions on monitors physically attending a site.
Benefits of Remote Monitoring:
- Remote access to trial databases and the availability of source data which may be redacted, scanned and emailed to the monitor reduces the requirement for an onsite presence.
- Utilising video conferencing such as Zoom allows a medium for face-to-face monitoring. Video conferencing can also be used to check source documents and consents.
- With access to study data online, monitoring can continue during periods of lockdown and can be conducted from the monitor’s home.
- Zoom calls can be conducted with site pharmacy for dispensing and allocation review.
Sponsors and research sites alike must factor periods of lockdown into their clinical trial strategy to mitigate as much risk as possible and ensure clinical trial monitoring can continue during periods of lockdown to ensure the review of participant safety, the conduct of the trial according to the protocol and to Good Clinical Practice.