What are the regulations governing the clinical trials of drugs?

In Oregon, the Oregon Administrative Rules (OARs) provide the regulations governing the clinical trials of drugs. OAR 333-031-0100 to 333-031-0370 cover the regulations for clinical trials of a drug, biologic, device, or medical food. Generally, to conduct a clinical trial in Oregon, an investigator must have an investigational new drug application (or IND) issued by the U.S. Food and Drug Administration (FDA). The IND must include an approved protocol, trial site information, and a list of the qualified investigator who will be involved in the study. In addition to the IND, the Oregon Health Authority (OHA) requires a study-specific Clinical Trial Research Plan (CTRP). The CTRP must provide detailed information about the investigator, trial site, and trial protocol, and must be approved by OHA in order to receive informed consent from patients. In addition, the OARs require that the investigator and research staff have specific qualifications and be adequately trained in the conduct of clinical trials. Furthermore, the research site must meet certain standards in order to ensure the safety and welfare of the patients involved in the clinical trial. Finally, the OARs require that clinical trials be conducted in accordance with FDA regulations and Good Clinical Practice (GCP) guidelines. In conclusion, in Oregon, the OARs provide the regulations governing the clinical trials of drugs. The regulations cover the requirements for obtaining an IND and CTRP approval, as well as the qualifications and training of research staff and standards of the research site. Additionally, clinical trials must be conducted according to FDA regulations and GCP guidelines.

What are the regulations governing the clinical trials of drugs?

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