Clinical monitoring refers to the oversight and vigorous administrative efforts that are made to monitor the health of a participant or a patient during a pre or post clinical trial. Every government institute and the clinical trial agency who is funding the monitoring requires relevant data as well as the safety monitoring boards so as to check the clinical trials.
The intensity of clinical trials monitoring:
The intensity of clinical trial monitoring will differ among various medical sites and across different studies. Now a question arises here, that whether a Clinical research consultant should be present while the medical site is having the study subjects? Should the Clinical research consultant have any interaction with the study subjects? In the early phases of the studies, a CRA might be required to be present during a part or all of the treatment of the subject. Therefore, it is the duty of the CRA to determine that how long they will be staying at the site and making the appropriate arrangements.
Sometimes the CRA is solely monitoring the site and at times he is monitoring with the other CRAs. It is the sponsor who is going to decide that who will monitor the site. And the sponsor will decide that based on the educational qualifications, age, and training of the consultant.
While conducting a clinical monitoring, the overall comprehensive monitoring plan of the clinical research consultant or associate should be fairly consistent. However, the strategy for each individual site might vary considerably during the study period depending upon the site performance as well as the course of study conditions.
Training in clinical trials
Apart from having the required educational qualifications, every clinical research consultant or associate should have a good medical training certificate. This will ensure integrity and honesty in all the procedures of site monitoring and establish the standards in the medical industry. A good clinical practice is also necessary to make sure that the staff is trained to take care of the health of the patient during the clinical trials as well as clinical monitoring.
Since years, many institutes have been providing superior quality training, support and networking to the community of clinical research. Training in clinical trials is particularly necessary for the consultants as they will learn to design, conduct, analyze and interpret the clinical studies in an accurate manner. With adequate training the consultants can interpret the results of the clinical trials appropriately. Such training programs build competence of the associates as well as improve their job performance. The research consultants will be able to get the most for their clients in this way.
Training in clinical trials will offer practical knowledge to the clinical research associates and they will learn many different tools and templates which will help them with their study implementation. After the completion of the required course, the candidate is given a certificate of training. This certificate further increases the chances of job prospects of the clinical research consultants or associates.