SOCRA CCRP Practice Exam

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Which section of the FDA progress report contains information on anticipated risks based on animal data or previous studies?

Individual study information
Summary information
General investigational plan
Risk management plan

The correct answer is: General investigational plan

The general investigational plan section of the FDA progress report contains information on anticipated risks based on animal data or previous studies. This section outlines the overall plan for the investigational drug and includes information on any potential risks that may arise during the study. Option A, individual study information, is incorrect because it focuses on a specific study, rather than the overall plan. Option B, summary information, may include some information on potential risks, but it is not the primary focus of this section. Option D, risk management plan, is incorrect because this section primarily addresses how potential risks will be managed, rather than simply identifying them.