Good Clinical Practice Quizzes (Questions + Answers) Verified 100% Correct!!.

A committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial. - Independent Data Monitoring Committee A compilation of the clinical and nonclinical data on the investigational product which is relevant to the study of the investigational product in human subjects. - Investigator's Brochure A copy of the original record that has been verified to have the same information, including data that describe the context, content, and structure, as the original. a. Certified Copy b. Clinical Study Report c. Essential Study Document d. Source Document - a. Certified Copy A document that describes the objective, design, methodology, statistical considerations, and organization of a trial and usually also gives the background and rationale for the trial. a. clinical study report b. informed consent form c. essential document d. protocol e. audit report - d. protocol A document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial. a. Audit Reportb. Monitoring Report c. Clinical Development Plan d. Monitoring Plan - d. Monitoring Plan