SOCRA CCRP Practice Exam

An IND application is a request submitted to the FDA by a pharmaceutical company or sponsor to start clinical testing of a new drug in humans. The essential components of an IND application include animal studies, manufacturing details, and clinical protocols. Option B is incorrect because financial disclosure forms and investigator resumes are not essential components. Option C is incorrect because while drug sourcing information and pharmaceutical formulations may be included, they are not essential components. Option D is incorrect because while clinical trial schedules and patient consent forms may be included, they are not essential components. Again, the essential components are animal studies, manufacturing details, and clinical protocols.