CCRC Exam - AACRP

To determine human toleration, both in terms of pharmacology and safety

To provide evidence of confirmation of the effective dose. These provide data on the safety/efficacy therapeutic ratio. They give the first indications of the likely clinical value of the investigational product compared to placebo or standard treatment. These studies are tied up with the regulatory authorities’ evaluation guidelines.

To evaluate the overall benefit/risk relationship in a large group of patients. To establish the comparative efficacy and safety of a treatment in order to substantiate the best method of the future patient’s treatment. These trials will define the labelling (the claim) and ultimately will position the drug on the market.

To continue the collection of long-term safety data and gather further useful information by investigating the “real-life effectiveness” of a new drug in a larger and more general patient population than is achieved in the selected patient populations from hospital specialist settings recruited in Phase III trials (monitors continued safety in large populations of subjects)

Compiles the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the investigational product(s) in human subjects for the purpose of facilitating the understanding of the protocol.