An introduction to clinical trial monitoring
Clinical trial Monitoring is the procedure performed to safeguard the rights and interest of the humanvolunteers. This procedure also ensures that the data that is recorded in clinical trials are high quality, accurate and precise. This article would tell about clinical trial monitoring.
How is clinical trial monitoring conducted?
What are the responsibilities of a monitor?
The medical monitor has certain responsibilities during the conduct of clinical trials. . Firstly, they ensure that the clinical trials are conducted in compliance with certain regulations. namely ICH GCP guidelines , schedule Y ,study protocols and other guidelines. Furthermore, the monitoring process includes validating and verifying the informed consent process by checking the different document and source notes alongside the conduct of other procedures associate ed with the study protocols. In addition to that, they check that the essential investigator files to see thatall 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. A the need of thus verification, it is sent the sponsor for analysis. Therefore, the clinical research associate or monitor has to conduct source data verification.
Other responsibilities of a monitor
The monitor also carries out other responsibilities . They ensure that the study drug is stored properly and kept in accordance with 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. Clinical research courses help one carry out their responsibilities
What does the monitor do at the end of the clinical trials visits?
Firstly ,they meet the principal investigator and discuss which activities had been conducted and which need to be corrected .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. Clinical research courses help with these procedures.