FDA and ICH Guidelines in Clinical Research Protocols

FDA and ICH Guidelines in Clinical Research Protocols

Clinical research studies are invaluable in enhancing evidence-based medicine as well as finding a resolution to medical challenges but are the most regulated type of research. Clinical trials tend to put the lives of individuals at risk thus the necessity for their close monitoring and regulation; a role played by the Food and Drug Administration (FDA) and ICH. The development of the clinical protocol is the initial step and the basis of clinical research study thus vital. The two bodies have set out standards that have to be accounted for in the design of clinical protocols with the main purpose of safeguarding the participants. The rules and regulations are founded on a concern for people’s…