Planning to write a report - Monash University
Purpose of the Study Protocol. Background. Prior Literature and Studies. Rationale for this Study. Study Objectives. Primary Aim. Secondary Aim. Rationale for the Selection of Outcome Measures . Investigational Agent . Preclinical Data. Clinical Data to Date . Dose Rationale and Risk/Benefits . Study Design . Overview or Design Summary. Subject Selection and Withdrawal . Inclusion Criteria ... ................
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