Why is monitoring required?
Monitoring is mandated by the Food and Drug Administration (FDA) in order to validate the integrity of the clinical trial. In general, this process is hugely personnel-intensive and involves site visits to inspect personnel, facilities, equipment, processes and documentation. It has been estimated that one third of the budget of the trial is spent on on-site monitoring. In an effort to minimize the time and costs involved in this process, the contract research organizations (CROs) emerged to support this task with virtual workspaces. These cost-effective remote strategies resulted in saving upto 70% of the resources spent on trials.
There are now available various types of monitoring that suits the purpose of each research clinics. Risk-based monitoring, remote monitoring and centralised monitoring are the broader options available to a sponsor to make it easier on both the site and the sponsor.
What is Remote Monitoring?
In the past few decades, the number and complexity of clinical trials have significantly increased across the industry. Owing to this, the monitoring has become a vital activity to ensure quality of data and protocols deployed. Remote monitoring includes monitoring activities that are formerly conducted on-site with an increased efficiency and quickened time to market. They include consistency checking, data completeness, identification of high error prone sites and protocol violations. The data can be reviewed by a clinical research associate through secure online workspaces. However, remote monitoring does not specify whether a study is risk-based monitoring or non-risk based monitoring.
The process starts with the research clinics executing the protocol as usual and entering the data on the electronic case report forms (eCRFs). Additionally, all the source documents, medical histories, informed consent forms and other related documents are also uploaded to a secured virtual workstation which is instantaneously accessible by the clinical research associate. The CRA then carries out the task of comparing the data on the source documents with that of the eCRF which is called as “monitoring visit”. Since this entire process takes place remotely, this is typically referred to as “remote monitoring”.
Is remote monitoring a replacement for on-site monitoring?
Remote monitoring process begins much before the site initiation phase which is characterised by activities such as IRB approval, submission of required documents, finalizing contracts and planning budgets. The virtual workspaces facilitate the collaboration of the clinical research associates and sponsors to finalize on the documents thus saving the cost and time significantly. Nonetheless, remote monitoring is not a replacement for on-site monitoring but a mere acceptable addition to the process. A subtle balance of on-site and remote monitoring should be maintained throughout the study. The strategy should be flexible enough to allow on-site monitoring, if need be.
What are the benefits of remote monitoring?
- Time saving
- Cost effective
- Less personnel required
- Easier documentation
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