SOCRA CCRP Practice Exam

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What are the essential components of an IND application?

Animal studies, manufacturing details, clinical protocols
Financial disclosure forms, clinical protocols, investigator resumes
Drug sourcing information, pharmaceutical formulations, budgetary outlines
Clinical trial schedules, patient consent forms, manufacturing processes

The correct answer is: Animal studies, manufacturing details, clinical protocols

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.