The clinical trials are scientific studies on the safety and
efficiency of the new drugs, devices or diagnostics and their
action on the human health, as well as on their risks and benefits, and
the suitable treatment regiments.
They are carried out on humans by
qualified physicians, called Clinical Investigators, Research Nurses, called also
CRC (Clinical Research Coordinators), Data Managers, Statisticians,
Pharmacists and other study staff, trained on the clinical trial
regulations.
The Clinical Research Coordinators work
in the medical clinics, where the studies take place and organize all the study
related activities and interactions with study participants at the
site, until the Principal Investigator is responsible for all the site
activities.
In order to
protect the rights and the safety of the human participants, the
Sponsor (the company that developed the new product), is obliged by law to engage Monitors, called Clinical Research
Associates (CRA), who supervise and inspect periodicallythe work of the physicians Clinical Investigators and their Coordinators at study sites to verify their compliance to Protocol and regulations and make sure that all
regulatory requirements are met and the quality of data is assured.
CRAs deal mainly with
physicians and research nurses in
trial centers, private GP practices or hospitals. They don't work with
patients, but with trial documentation, therefore they don't need to be
licensed professionals. In the rare cases, when the CRA has to take
blood samples, the job description will explicitly mention 'Licensed Phlebotomist'.
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