Clinical Trial Monitoring is a very responsibility-filled duty that is performed to ensure that the rights, well-being, and safety of the clinical trial subjects are protected, and that the data coming out of a clinical trial is realistic and accurate. The monitoring is conducted by a sponsor representative, one like a Clinical Research Associate, who at frequent intervals, personally visits the clinical trial site where the sponsors study is being conducted.
What are the duties of a Clinical Trial Monitor?
- The Clinical Trial Monitor must ensure that the trial is being conducted in accordance with ICH GCP guidelines, Schedule Y, study protocol, and all other applicable guidelines. All essential documents available in the investigator site files also need to be reviewed thoroughly to ensure that all the important documents are available and up-to-date as specified in the ICH GCP.
- The informed consent process should be verified by evaluating the associated documents and source notes, along with the conduct of other procedures associated with the study protocol. The data filled by the site staff in the case report forms also need to be cross-checked against source documents like the patient’s hospital file, patient diary, previous prescriptions, and the like.
- All the communication of the site with the ethics committee is also reviewed to ensure that all safety updates, serious adverse events, protocol amendments, and every other important information is submitted to the committee by the sites, as per the regulations and guidelines. Any serious adverse events that have not been reported is also checked for.
- Proper storage of study drug and maintenance of all related accountability logs is important to ensure that the study drug is being used in accordance with the clinical trial protocol. This is also checked by the monitor.
- Lastly, it is the monitor’s duty to meet the principal investigator to discuss the activities that were conducted, and the things that need to be corrected.
- Once the site visit is complete, the monitor must write a monitoring visit report, writing about all the activities that were conducted at the site, along with all the findings, observations, deviations, and corrective action taken. A follow up letter is also required to be sent to the principal investigator enlisting the activities with any follow up or corrective actions required from the site staff.
What are the qualities of a Clinical Trial Monitor?
The Clinical Trial Monitor needs to be supportive of the site and have good interpersonal relationships with the site staff. They should consider the site staff as part of their team, and should guide them at every step in the process. All the tasks should be completed, without the monitor appearing dominating or showing too much authoritative attitude. In short, the Clinical Trial Monitor should be able to get along well with everyone.
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