Clinical trials generate data on safety and efficacy. Clinical trials are closely supervised by appropriate regulatory authorities. All studies involving a medical or therapeutic intervention on patients may not be approved by a supervising ethics committee before permission is granted to run the trial.
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A protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents.
A. 对
B. 错
Clinical study is any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.
A. 对
B. 错
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
A. 对
B. 错
For a primary research, data does not exist at the beginning of the study and a researcher has to collect the data using appropriate methods.
A. 对
B. 错