Monday, 18 March 2019

Clinical Trial Monitoring – What Is It?

Clinical trial monitoring checks on the safety, rights, and well-being of clinical trial subjects to ensure that they are protected. It also checks for the data coming out of a clinical trial to be accurate and credible. This kind of monitoring is carried out by a sponsor representatve, like the Clinical Research Associate (CRA) by visiting a clinical trial site in person at regular intervals, where the sponsors study is being conducted. Along with other duties andresponsibilities of a CRA , there is a lot that the CRA has to do to conduct a clinical trial monitoring.

1)    Accordance of trial with guidelines and regulations
The CRA ensures that the trial being conducted is in accordance with the ICH-GCP guidelines, study protocols, Schedule Y, and any other guidelines and regulations that are required. The process 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. Also, all the essential documents available in the investigator site files are reviewed to make sure that all the documents specified in the ICH GCP are available, and that the file is up to date. The source data is also verified and cross checked, that is, the data filled by site staff in case report forms is checked against source documents like hospital files, previous prescriptions, etc.

2)    Storage and safety of drugs
Clinical trial monitoring also ensures proper storage of the study drugs and maintenance of all related accountability logs to ensure that the drugs being used are in accordance with the clinical trial protocol.

3)    Submission of events and updates to the EC
All the communication of the site with the ethics committee is also reviewed to ensure that all safety updates, serious adverse events, any protocol amendments, etc. are submitted to the EC as per the guidelines and regulations.

4)    Checking of any serious adverse events
The CRA is also required to check for any serious adverse events that may have occurred at the site, which may not have been reported by the site staff to the study sponsor.

5)    Meeting with the principal investigator
The CRA should make it a point to meet the principal investigator to discuss the activities that were conducted, and the things that need to be altered and corrected.

6)    Monitoring visit report
Once the visit at the site is complete and the monitoring process is done, the CRA is required to write a monitoring visit report, documenting the activities that were conducted at the site, and other observations and findings. He must also list down any corrective measures that may have been taken. A follow up letter is then sent to the principal investigator informing him of the same; and the monitoring report must be filed in the study site files available with the sponsor.

7)    Personal attributes
Along with all the above duties and responsibilities, it is important that the CRA has certain personal attributes too like being supportive and having good inter-personal relationships with the site staff. He should be able to guide the staff as appropriate, without appearing dominating or showing any kind of over-authoritative attitude.

Want to become a CRA and take up all such responsible duties on your shoulders for the betterment of the clinical research industry of your country? Then, get enrolled with one of the best clinicalresearch institutes in Bangalore, like Avigna Clinical Research Institutes, where you can be educated by the best professionals and earn a legitimate certification, and a guaranteed job in top CROs, Bio-techs and pharmaceutical companies.

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