SOCRA CCRP Practice Exam

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What precautions must an investigator take if the Investigational Product (IP) is subject to the Controlled Substances Act?

Limit access and store IP in a secure location
Distribute IP freely within the facility
Allow subjects to take IP home
None of the above

The correct answer is: Limit access and store IP in a secure location

An investigator must take precautions and limit access to the Investigational Product (IP) if it is subject to the Controlled Substances Act. This means that they must store the IP in a secure location, such as a locked cabinet, to prevent unauthorized access. Distributing the IP freely within the facility (option B) could lead to unauthorized access and potential misuse of the controlled substance. Allowing subjects to take the IP home (option C) also increases the risk of misuse or diversion of the controlled substance. Therefore, both options B and C should be avoided. Option D, "None of the above," is incorrect as it does not mention any precautions that should be taken by the investigator.