Who can the investigator delegate responsibilities for product accountability to?

The correct answer is that investigators can delegate responsibilities for product accountability to qualified personnel, such as pharmacists or coordinators. In the context of Good Clinical Practice (GCP), the investigator holds ultimate responsibility for the integrity of the trial and for ensuring compliance with ethical and regulatory standards. However, it is essential for the investigator to effectively manage their responsibilities, which can include delegating certain tasks.

Qualified personnel, such as pharmacists and clinical trial coordinators, possess the necessary training and knowledge to handle product accountability appropriately. They can manage responsibilities such as tracking inventory, ensuring proper storage conditions, dispensing products, and maintaining accurate records. This delegation allows for a more efficient workflow within the trial while still maintaining oversight by the investigator.

Delegating these tasks to appropriately qualified individuals ensures that the product accountability is conducted professionally and adheres to all regulatory requirements, thus minimizing risks in the study and safeguarding participant safety.

In contrast, study sponsors, trial participants, and independent auditors are not appropriate choices for delegating product accountability. Sponsors are typically responsible for funding and overseeing the study, while trial participants should not be involved in handling investigational products due to concerns about bias and safety. Independent auditors are meant to assess compliance and should not be part of the accountability process.