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Question: 1 / 400

Can investigators delegate accountability for investigational products to other qualified personnel?

Yes

It is appropriate for investigators to delegate accountability for investigational products to other qualified personnel as long as proper oversight and guidelines are followed. The principal investigator holds ultimate responsibility for the conduct of the trial and the safety of the participating subjects, but they can delegate certain tasks related to the handling of investigational products to qualified individuals.

This delegation must be based on the qualifications and training of the personnel to ensure they understand the protocols and procedures required for the safe and effective management of the investigational products.

Delegation is a common practice in clinical research, allowing for efficient operations while maintaining compliance with regulatory standards. This practice also enhances patient safety by ensuring that trained personnel are managing investigational products appropriately. However, the overarching accountability remains with the principal investigator, who must ensure that delegated individuals are capable of carrying out their responsibilities effectively.

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No

Only to subinvestigators

Only after FDA approval

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