SOCRA CCRP Practice Exam

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What are the core components of an FDA 1572?

Commitment to regulations
Investigator's name/address, Protocol name/code, Name of facilities, Name/address of lab, Name/address of IRB, Names of sub-Is, Commitment to regulations
Name and address of the sponsor
Financial disclosure information

The correct answer is: Investigator's name/address, Protocol name/code, Name of facilities, Name/address of lab, Name/address of IRB, Names of sub-Is, Commitment to regulations

The core components of an FDA 1572 form include the investigator's name and address, the protocol name and code, the names and addresses of facilities and laboratories involved in the study, the names of any sub-investigators, and a commitment to comply with FDA regulations. Option A is incorrect because it only lists one of the required components and does not include the names and addresses of facilities and labs. Option C is incorrect because it only includes the sponsor's name and address, and Option D is incorrect because financial disclosure information is not a required component of the FDA 1572 form.