Clinical trials are research studies on subjects that are designed to determine behavioral interventions like novel vaccines, drugs, treatments, devices or new ways of using known interventions, generating safety and efficacy data. They are conducted only after satisfactory information has been gathered that satisfies health authority/ethics committee approval in the country where approval of the therapy is sought. This will be done by preparing a protocol. A clinical trial protocol is a document used used to define and manage the trial. It is prepared by a panel of experts.
Last date updated on July, 2014