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According to ICH GCP E6(R1), 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."
» According to ICH GCP E6(R1), Informed consent is "A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form."
» According to ICH GCP E6(R1), Case Report Form (CRF) is "A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject. "
» According to ICH GCP E6(R1), Clinical Trial/Study Report is "A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report."
» According to ICH GCP E6(R1), Investigator Brochures is "A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects."
