SOCRA CCRP Practice Exam

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What requirements does ICH GCP state for sponsors regarding IP accountability?

Developing marketing strategies
Ensuring timely delivery of IP to investigators, maintaining records of shipment, receipt, disposition, return and destruction, maintaining systems for retrieving and disposition of unused IP, ensuring IP stability, maintaining sufficient quantities of IP
Staff hiring practices
Ensuring all trials have adequate insurance

The correct answer is: Ensuring timely delivery of IP to investigators, maintaining records of shipment, receipt, disposition, return and destruction, maintaining systems for retrieving and disposition of unused IP, ensuring IP stability, maintaining sufficient quantities of IP

ICH GCP (International Conference on Harmonization Good Clinical Practice) provides guidelines for clinical trials. One of the key requirements for sponsors is to ensure proper accountability for investigational product (IP) throughout the trial. This includes ensuring timely delivery of IP to investigators, maintaining records of shipment, receipt, disposition, return and destruction, maintaining systems for retrieving and disposition of unused IP, ensuring IP stability, and maintaining sufficient quantities of IP. Options A, C, and D are incorrect as they are not relevant to the requirements for sponsors regarding IP accountability.