All of the following must be included within the protocol document, EXCEPT

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The study protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of the trial.The protocol document must contain the following elements: a statement of the study objectives and purpose; the criteria for patient inclusion/exclusion as well as an estimate of the number of patients to be studied; a description of the design of the study, including the kind of control group to be used (if any) and a description of methods to be used to minimize bias on the part of subjects, analysts and investigators; method for determining the dose(s) to be administered, the planned maximum dosage and duration of individual exposure to the subject from the study drug; objectives of the study, which include an explanation of observations and measurements to be made; and a description of clinical procedures, laboratory tests or other measures to be taken to monitor the effects of the drug in subjects and to minimize risk.

All of the Following Must Be Included Within the Protocol