Clinical Trial Monitoring Process
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.
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 the 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.
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 enlist any observations, findings, protocol deviations, conclusions and actions taken or to be taken and/or actions recommended to secure compliance.