Definition of Clinical Trial Monitoring
Clinical trial monitoring is performed to ensure the rights and well-being of human subjects are protected, the reported trial data are accurate, complete, and verifiable from the source documents and to verify that the conduct of the trial is in compliance with the currently approved protocol/amendments, with GCP, and with the applicable regulatory requirements.
Clinical Trial Monitors
The sponsor appoints a person with appropriate training and scientific and/or clinical knowledge to monitor a clinical trial. Monitors should be thoroughly familiar with the investigational product(s), the protocol, written informed consent form and any other written information to be provided to subjects, the sponsor’s SOPs, GCP, and the applicable regulatory requirements.
Monitor’s Responsibilities
The responsibility of the clinical trial monitor is to ensure that the trial is being conducted in accordance with ICH GCP guidelines, study protocol and any other guidelines as applicable. The process of clinical trial monitoring involves verifying the informed consent process by reviewing the associated documents and source notes, along with the conduct of other procedures associated with the study protocol. Clinical trial monitoring also includes reviewing the essential documents available in the investigator site files to ensure that all essential documents as specified in ICH GCP are available and the file is up to date, and conducting source data verification which is to cross check the data filled by the site staff in the case report forms (CRFs) against source documents such as patients hospital file, previous prescriptions, patient diary etc.
Clinical trial monitoring also involves reviewing all the communication of the site with the ethics committee to ensure that all serious adverse events, safety updates, any protocol amendments, etc are submitted to EC by the sites as per regulations and guidelines.
A monitor also ensures the proper storage of study drug and maintenance of all related accountability logs to ensure that the study drug is being used in accordance with the clinical trial protocol. A monitor during the monitoring visit must also ensure to check for any serious adverse events that may have occurred at the site which may not have been reported to the study sponsor by the site staff.
Monitoring Report
Once the clinical trial monitoring visit is complete the monitor should submit a monitoring visit report to the sponsor and in it document the activities that were conducted at the site and also enlist any observations, findings, protocol deviations, conclusions and actions taken or to be taken and/or actions recommended to secure compliance.
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