SOCRA CCRP Practice Exam

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What is the first step in administering an investigational drug according to 21 CFR 312?

Administer drug only under the supervision of a sub-investigator
Ensure all subjects have signed consent
Administer drug only to subjects under the investigator's personal supervision
Send all drugs back to the sponsor for approval

The correct answer is: Administer drug only to subjects under the investigator's personal supervision

The first step in administering an investigational drug according to 21 CFR 312 is to ensure that the drug is only administered to subjects under the personal supervision of the investigator. This means that the investigator must be present while the drug is being administered and oversee the entire process. Option A is incorrect because while it is important for a sub-investigator to be involved in the administration, they should not be the only one supervising. Option B is incorrect because obtaining informed consent from all subjects is an important step, but it should not be the first step. Option D is incorrect because sending drugs back to the sponsor for approval would delay the administration process and is not the first step in administering an investigational drug.