SOCRA CCRP Practice Exam

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How soon must a sponsor report to FDA if a drug presents an unreasonable and significant risk to subjects?

10 working days
15 working days
5 working days
20 working days

The correct answer is: 5 working days

The correct timeframe for a sponsor to report to the FDA when a drug presents an unreasonable and significant risk to subjects is 5 working days. This requirement is stipulated in the regulations to ensure that issues that could impact participant safety are addressed rapidly. Timely reporting is crucial, as it enables the FDA to take necessary actions to protect trial participants and maintain oversight of ongoing studies. In clinical research, the emphasis on swift communication demonstrates the importance of vigilance in monitoring safety and efficacy. This regulation aligns with the FDA's broader commitment to safeguard public health and enhance the integrity of the research process. Notably, if there's a significant risk identified, the sponsor must act quickly to relay that information, which helps in mitigating potential negative outcomes for participants enrolled in ongoing studies.