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A Clinical Research Associate (CRA) can also be called a Monitor, a Clinical Monitor, a Trial Monitor or a Medical Monitor.
A CRA is an individual employed by a pharmaceutical or medical device manufacturer, by a contract research organization (CRO)
usually acting on a sponsor's behalf or by an academic institute conducting clinical trials. A clinical trial is a
process in which a medication or other medical treatment is tested for its safety and effectiveness.
Federal Regulations require
that sponsors of clinical studies select individuals who are qualified by training and experience to monitor their studies 21 CFR 312.53 (d).
ICH Guidelines 5.18.2 (b) also states that Monitors be appropriately trained and their qualifications documented.
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