Certified Clinical Research Associate (CCRA) Practice Exam 2025 – All-in-One Guide to Master Your Certification!

Question: 1 / 400

When should regulatory authorities be notified of fatal or life-threatening unexpected ADRs?

Within 15 calendar days

As soon as possible, but no later than 7 calendar days

Regulatory authorities should be notified of fatal or life-threatening unexpected adverse drug reactions (ADRs) as soon as possible, but no later than 7 calendar days. This prompt reporting is crucial because it allows the regulatory bodies to take necessary actions to protect public health by assessing the safety of the drug in question. Since these types of reactions can have serious implications for patient safety, the urgency of the notification reflects the need for rapid response to potential risks associated with the drug's use.

This time frame ensures that any emerging safety concerns are promptly addressed in order to facilitate timely investigation and necessary measures, such as product recalls or additional warnings to healthcare providers. The requirement for immediate notification within this time limit emphasizes the critical nature of such events in pharmacovigilance.

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Within 24 hours

At any time within 30 calendar days

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