Certified Clinical Research Associate (CCRA) Practice Exam 2026 – All-in-One Guide to Master Your Certification!

Question: 1 / 400

After drug approval, what is the focus of Phase 4 studies?

Initial drug safety

Therapeutic use

Phase 4 studies, often referred to as post-marketing surveillance, primarily focus on the therapeutic use of a drug after it has been approved by regulatory authorities. During this phase, researchers gather extensive data on the drug's performance in the general population to further evaluate its effectiveness, monitor long-term outcomes, and observe any rare side effects that may not have emerged during earlier clinical trials.

This stage is critical as it helps to determine how well the drug works in real-world settings, assess its benefits and risks, and find the best management strategies for its therapeutic use. Additional factors such as dose adjustments, drug interactions, and patient adherence can also be more thoroughly understood during these studies, making them integral to continued drug evaluation and optimization in everyday clinical practice.

The other options pertain to different aspects of drug development and evaluation. Initial drug safety pertains more to earlier phases of clinical trials, while initial human trials focus on establishing safety and efficacy. Research designs for medications refer to the methodologies used in various stages of clinical research but do not specifically capture the goals of Phase 4 studies.

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Initial human trials

Research designs for medications

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