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

Expedited reporting is a critical component of pharmacovigilance, particularly concerning adverse drug reactions (ADRs) in clinical trials and post-marketing settings. The requirement for expedited reporting is specifically tied to the seriousness and unexpected nature of the adverse reactions.

When an adverse drug reaction is both serious—indicating that it results in significant outcomes, such as hospitalization, disability, or is life-threatening—and unexpected—meaning that it does not align with the known safety profile of the drug as described in the product label or in previous studies—it prompts immediate attention from regulatory bodies. This is because such reactions can indicate potentially significant safety concerns that might require prompt intervention or further investigation.

In contrast, adverse reactions that are serious but known (expected) do not require the same level of immediate reporting, as the risks are already understood and accounted for in the study’s risk management and communication plans. Additionally, non-serious adverse reactions, regardless of whether they are expected or unexpected, typically do not require expedited reporting because they do not pose an immediate risk to patient safety. Thus, the requirement for expedited reporting is specifically linked to ADRs that are both serious and unexpected, underscoring the importance of closely monitoring these types of events to ensure patient safety and regulatory compliance