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Which of the following is true when a sponsor's responsibilities are transferred to a Contract Research Organization (CRO)?

a) The sponsor retains all responsibilities
b) The CRO assumes all sponsor responsibilities
c) Both the sponsor and CRO share responsibilities
d) The investigator takes on sponsor responsibilities

1 Answer

3 votes

Final answer:

In a collaboration between a sponsor and a Contract Research Organization, they share responsibilities for conducting the clinical trial. The CRO assumes various tasks, but the sponsor ultimately retains overarching responsibility for compliance and the overall integrity of the drug development process.

Step-by-step explanation:

When a sponsor's responsibilities are transferred to a Contract Research Organization (CRO), it is typically the case that both the sponsor and the CRO share responsibilities. Although the CRO can assume many of the duties initially held by the sponsor, the ultimate responsibility for the integrity of the drug development process and compliance with regulatory requirements often remains with the sponsor. This is a critical collaboration, with the CRO generally taking on tasks such as site identification and assessment, study monitoring, data management, and possibly trial design while the sponsor oversees product development strategy, maintains the investigational new drug (IND) application, and ensures regulatory compliance.

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