Clinical Trial Monitoring is mainly performed to ensure that the rights, safety and well being of the clinical trial subjects are protected and that the data that comes out of a clinical trial is credible and accurate.
Clinical trial monitoring is conducted by a sponsor representative, usually a clinical research associate (CRA) by actually visiting a clinical trial site in person at frequent intervals where the sponsors study is being conducted.
The responsibility of the monitor is to ensure that the trial is being conducted in accordance with ICH GCP guidelines, Schedule Y, study protocol and any other guidelines/regulations as applicable. The process of 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. The data in the case report forms is sent to the sponsor for analysis, thus to conduct source data verification is a very important duty of a clinical research associate.
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.
At the end of the visit the monitor must make it a point to meet the principal investigator to discuss what activities were conducted and what things need to be corrected or rectified. Do not forget to appreciate them if they have done a good job!
A monitor must be supportive of the site and good inter personal relationships with site staff are very important. A CRA should consider the site staff as a part of his team and should guide them at all steps to ensure that work gets done as it should be without being dominating or showing too authoritative attitude. This may cause a negative impression of the monitor which can affect the work at the site. To get along well with anyone is a good quality of a monitor.
Once the monitoring visit is complete the monitor must write a monitoring visit report and in it document the activities that were conducted at the site and also enlist any observations, findings, protocol deviations and corrective action taken. A follow up letter is then sent to the principal investigator again enlisting the activities that were conducted during the monitoring visit, and any follow up or corrective actions required from the site staff. The monitoring report must be filed in the study site files available with the sponsor.
