WHAT SAFEGUARDS EXIST TO MONITOR CLINICAL RESEARCH TRIALS?
Several safeguards have been put into place that all companies must follow when conducting clinical trials. The Food and Drug Administration (FDA) is the regulatory agency that oversees all clinical research conducted in the United States. They are responsible for protecting the rights and, to the degree possible, the welfare of subjects participating in clinical trials. They ensure that data collected from clinical trials is of high quality and they are the agency that determines whether a new treatment should be sold in the US. Several organizations and individuals are governed by FDA regulations including clinical investigators, sponsors (i.e., the companies developing the treatments), Contract Research Organizations (i.e., companies that help conduct the studies), and Institutional Review Boards (groups that are responsible for ensuring the safety and welfare of study participants). Good Clinical Practice (GCP) guidelines are another safeguard implemented to protect the safety of s
