Abstract
This presentation will describe the practical activities of clinical research associates (CRAs) and clinical research coordinators (CRCs) during the conduction of a typical clinical investigation with a new drug in the United States. There are an estimated 12, 000-15, 000 CRCs working at investigation sites in the US . Approximately 2, 000 CRCs have become certified since 1993. Probably more than 25, 000 clinical research . associates work in the US pharmaceutical industry companies or CROs in the US; 500 of these CRAs have become certified since 1995. Study activities will be reviewed and discussed from a chronological perspective, beginning with pre-study preparation activities and ending with preparation of a clinical study report. US GCP requirements supporting each of the activities will be described.
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