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.
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