ABSTRACT
Clinical research on human subjects is an activity regulated by an agency of the federal government (the Food and Drug Administration [FDA]). Therefore, clinical research records of the sponsor as well as the investigator are subject to audit in the same manner and with the same vigorous federal scrutiny as are financial records. In addition, by contract and by law, the study sponsor and the Institutional Review Board (IRB) also are authorized to perform a rigorous audit of the investigative site’s research activities. Since an audit is inevitable, the wise Clinical Research Associate (CRA) will see to it that each investigator maintains all research documents in accordance with the regulations and contracts.
