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Question: 1 / 400

Which stage of clinical trials does NOT require inclusion in the clinical trial registry?

A Phase I studies

Phase I studies focus primarily on assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug in a small group of participants. These trials are often considered exploratory and are primarily designed to establish whether a drug is safe for use in humans. Due to their preliminary nature, they do not always require registration in clinical trial registries under certain regulations.

In contrast, Phase II and Phase III studies generally involve larger populations and aim to evaluate the effectiveness of the drug, as well as further assess its safety. These phases are more structured and require a higher standard of transparency and regulatory oversight, which is why they are typically mandated to be registered in clinical trial registries to enhance public access to information about ongoing clinical research.

Therefore, the lack of requirement for Phase I studies to be included in clinical trial registries aligns with the regulatory intent to ensure that early-stage studies prioritize safety assessments without the same level of public accountability expected in later-stage trials.

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B Phase II studies

C Phase III studies

D None of the above

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