Certified Clinical Research Coordinator (CCRC) Practice Exam

The primary source of data included in the initial Investigator's Brochure during a Phase I new drug study is preclinical data. This data is crucial as it provides the foundational information about the drug's safety profile and biological activity before it is administered to humans.

In Phase I trials, the focus is on assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of a new drug. Preclinical data, which comes from laboratory studies and animal testing, covers aspects such as dosage, side effects, and mechanisms of action. This information ensures that researchers and investigators understand potential risks and therapeutic effects when determining the appropriate dosage and monitoring protocols for the human subjects involved in the trial.

The other types of data mentioned, such as clinical trial data, post-marketing surveillance data, and longitudinal study data, are typically gathered during later phases of drug development or after a drug is already on the market. Therefore, they are not part of the foundational data used in the initial stages of human trials presented in the Investigator's Brochure.