When patients enroll in a clinical trial, they must sign informed consent form to show they know what they are getting into. This is essentially a contract between the patient (usually called a subject or participant) and the sponsor of the clinical trial. The informed consent form is written at the same time as the protocol, but is adapted by the site where the study is done to accommodate local conditions. Sometimes a clinical trial is done on one site, sometimes over 50 sites.
Every protocol must pass through an institutional review board (IRB) in the United States. These groups of professionals drawn from the clinical study site are called an EIC in the United Kingdom. Find out what the acronym stands for and anything else you can about IRBs and EICs. Here to get you started are some documents.
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