CITI Training Practice Exam

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What is the primary source of data for a Phase 1 new drug study in humans?

Clinical trials
Preclinical data
Post-marketing surveillance data
Public health records

The correct answer is: Preclinical data

Preclinical data is the primary source of data for a Phase 1 new drug study in humans because it includes information from laboratory and animal studies that are conducted before the drug is tested in humans. This data is used to assess the safety and potential efficacy of the new drug before it is administered to human participants in clinical trials. Although clinical trials (A) are an important source of data in drug development, they are not the primary source for a Phase 1 study. Post-marketing surveillance data (C) and public health records (D) are gathered after a drug has been approved for use and are not used in the early stages of drug development.