Clinical monitoring is an essential part of every clinical trial. Sponsors review the data and regulatory documents in order to validate the safety and efficacy of a drug or device as it progresses through the entire lifecycle of a study, from start to finish.
Monitors will come on site to audit the data from the patients’ medical records and source. Monitors issue queries based on data inconsistencies between patient records and what is recorded in the electronic data capture system (EDC). They will also usually visit the pharmacy to confirm the drug dispensing records. Usually 1-2 monitors who are employed either by the sponsor or an independent contracted CRO will conduct the visits. Due to the COVID-19 pandemic, many sites have requested that monitoring visits be done exclusively remotely. This has necessitated the need to upload electronic source data and medical records to an electronically shared folder for monitor review.
Remote monitoring, in which the clinical monitor is not physically present at the site of study, has become the go-to for large institutions. Remote visits requires the onsite team to upload source documentation to a shared electronic folder so that the monitor can audit the data source against what has been entered into the EDC. Many clinical sites have pushed for remote monitoring visits due to the COVID-19 pandemic. However, electronic medical record system capabilities and CRC capacity to scan and upload paper source documentation has become the barrier to total remote monitoring.
Centralized monitoring is a review of patient data from multiple research sites or across patient populations at a remote, central location. Centralized monitoring is done done by site monitors, data managers, and biostatisticians. Examples of centralized monitoring include panel review of clinical data (e.g., structured interviews) by a third party for quality assurance purposes or for regulatory submission, review of patient laboratory results, and auditing of clinical record documentation at a central office.
There are several different types of clinical monitoring, but it’s important to always have the sponsorship and study integrity in mind.
Monitoring is an important part of clinical trials, and it is needed to protect one of the most critical aspect of study integrity: data collection. Because monitoring is such a large part of sponsor responsibilities, it’s important to understand how different types of monitoring affect study design. On-site monitoring involves having someone on location to oversee activities related to the trial site; remote or centralized monitoring means that a sponsor or third party monitors all sites remotely. By continual monitoring at set time points, monitors are able to identify mistakes sites might be making, protocol clarifications that are needed, and can ensure that patient safety is a priority.
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