Unlike the Ordinary Expanded Access Situation, It Is Unethical to Withdraw

question 30

True/False

Unlike the ordinary expanded access situation, it is unethical to withdraw an effective investigational product from a research subject who has a serious disorder or faces a significant risk of death and who has responded favorably to the investigational product.

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Definitions:

Exception

An instance or occurrence that does not follow the established rule, norm, or expectation, often requiring special handling or consideration.

Corrective Action

Measures taken to rectify faults or deviations identified during quality assessment or performance review processes.

Transactional Leadership

Involves leader–follower exchanges necessary for achieving routine performance agreed upon between leaders and followers.

Inspirational Relationships

Connections between individuals that uplift, motivate, and encourage positive changes or actions.