ACRP Certified Professional Practice Exam 2025 – The All-in-One Guide to Exam Success!

When a subject experiences a heart attack that is not documented in the Investigator's Brochure (IB), it must be reported to both the sponsor and the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) immediately. This is critical because the safety and well-being of the study participants must be prioritized, and any serious adverse events need to be communicated promptly to ensure that all stakeholders are aware and can take appropriate action.

The sponsor is responsible for overall oversight of the clinical trial and needs to be informed to evaluate the implications for the study as a whole, which may include reassessing risk factors or modifying the study protocol. Similarly, the IRB/IEC is tasked with ensuring that the rights and welfare of study participants are protected, and a serious event like a heart attack must be evaluated in the context of the study to determine if any additional measures are necessary. Reporting an unexpected and serious event like this is a significant part of regulatory compliance and ethical responsibility in clinical research.