Clinical Trial Monitoring
Clinical Trial Monitoring refers to the act of monitoring the conduct of a clinical trial, ensuring that the trial is being conducted within compliance of regulations, protocol, SOP (Standard Operating Procedures) and GCP (Good Clinical Practice).
The sponsor representative or clinical research associate (CRA) is responsible for the monitoring of a clinical trial by visiting the clinical trial site in person at intervals set forth within the monitoring plan for a research study. The sponsor ensures the proper execution of the clinical trial and extent of the monitoring needs on the basis on a few considerations including objective, design, purpose, blinding, complexity, endpoints, and size of the trial. Irrespective to any case or any clinical trials, there is always a need for the on-site monitoring before, after and during the clinical trial. Clinical Trial Monitoring is performed to ensure the safety, well-being and rights of the subjects participating in the clinical trial are protected. It also makes sure that the data collected after the trial is accurate and credible in every aspect.
The process of the excellent clinical trial monitoring consists of the verification of the informed consent process by evaluating the affiliated documents, conduction of the study within the protocol, and source notes. The sponsor can even appoint any person with the appropriate training and clinical/scientific knowledge to monitor the clinical trial.
The process of excellent clinical monitoring is a vast point to look-upon and study. The clinical monitoring is even costly as well as a critical aspect of the clinical trial. The primary objective of the excellent clinical trial monitoring is enhancing the safety of the subject along with improving the performance of the site with deeper insights. The overall communication of the site and investigators with the ethics committee must be reviewed to make sure that the safety updates, serious adverse events, protocol amendments, and more are submitted to the committee as per the guidelines and regulations. Proper storage of the study drug is even maintained to ensure the usage of the study drug in correspondence with the clinical trial protocol.
According to the US Food and Drug Administration’s centre of drug evaluation and research, the top faulty categories caught by various clinical monitors are:
- Failure to follow up with the investigation protocol
- Inadequate or unclear informed consent forms
- Failure in reporting the adverse events
- Failure in accounting for the arrangement of study drugs
- Failure in keeping the accurate and sufficient records of the trial
The five responsibilities of excellent clinical monitoring include:
Site qualification and selection in accordance with ICH GCP and protocol requirements
A Pre-Selection Visit (PSV) is organized to make sure about the qualifications of the site for the respective clinical trials. The site selection should be finalized in compliance with the rules and regulations after having an overall knowledge of the site where the trial is planned to conduct. A legible legal site contract must be made along with the budget to carry out the respective clinical trial.
Routine site monitoring
A routine site visit is necessary after, before and during the trial for the safety assurance and proper conduction of clinical trial until the ultimate close-out. Every motivational or monitoring visit must be accounted in logs to have a check on the safety monitoring of the trial. After every monitoring visit, a report regarding the monitoring visit shall also be maintained which should consist of the activities that were being conducted by at the clinical site, observations made while visit, findings and protocol deviations(if any) along with the curative measures taken to fix the deviations. All the monitoring reports must be registered in the study site files with the sponsor. The visits should even assure if the GCP (Good Clinical Practice) are being followed or not.
Clear and stable communication must be maintained on the clinical site in order to report the events and collected data at a faster yet reliable pace. Every piece of contact with the site manager must have a recorded in the master file of the clinical trial. The team who are responsible for the execution of the respective clinical trial must be trained and have the experience to perform the clinical trial. Extensive plans for monitoring should be maintained by the site manager in order to conduct a safe trial. The minimal protocol deviations and violations corresponding to the regulatory terms must be logged in the file.
Performing Risk Assessment
Before conducting a clinical trial, it is mandatory to assess the risk related to the execution. The trial manager/chief investigator or the person who is designated for the monitoring of the trial shall review the risks to the sponsor as well as the subject. If in case the trial involves high risk, then more frequent site visits should be considered. The lower risks may require central or remote monitoring. The performing of the risk assessment will lessen the chances of any adverse events by 90%. It is an essential step for the safety of the subject participating in the trial.
Tracking Protocol Violations/Deviations
A clear protocol should be made to give guidelines for the trial. The clinical trial must be conducted in adherence to the written protocol. There may be a few deviations in accordance with the protocol. The site manager who is responsible for the monitoring shall also take care of the measures to reduce the rate of deviations. A proper log should be maintained to keep track of the violations and deviations in compliance with the regulations along with reporting of the adverse events of the trial.