About Clinical Research - ARGENX 2682-0011
More Information About Clinical Trials
To help ensure that a research study is ethical and that patients' rights are protected, Institutional Review Boards (IRB), Ethics Committees (EC) or Ministry of Healths (MOH) review and approve study protocols that detail all aspects of how the study is conducted. There are also teams that monitor the study called Clinical Research Associates; they visit the study sites to make sure the study protocol procedures, research requirements and country regulations are being followed throughout the study. Health authorities may also inspect the study sites to ensure the safety and rights of the subjects participating in a trial and the integrity of the research study objectives.
Participants who meet all required criteria for a clinical trial may take part. The study team at the clinic will review the participant’s medical history and current medical status to make sure he or she is a good fit to participate in the study.
An investigational drug is a product that has not been approved by a country’s regulatory authorities (eg, the U.S. Food and Drug Administration) for medical use.