Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

True or False: Rapid communication to regulatory authorities may be necessary if new information materially influences the benefit-risk assessment of an investigation/product.

1. True

2. False

3. Only if adverse events are reported

4. Only if the trial is phase 3

The correct answer is: True

The statement is true because prompt communication with regulatory authorities is essential when new information emerges that significantly impacts the benefit-risk assessment of an investigation or product. Regulatory bodies expect sponsors to maintain transparent and timely communication to ensure that they are aware of any developments that could influence the safety and efficacy evaluation of a product. This communication is crucial not only for upholding regulatory compliance but also for protecting participant safety. It helps ensure that regulators can assess whether the risks associated with the product remain acceptable in light of the new information. This obligation extends beyond just adverse events; any data that could affect the overall evaluation of a product's benefits versus risks should trigger reporting to maintain integrity within the clinical trial process and ongoing assessments of the product. The other options suggest limitations on when communication is necessary, which doesn't capture the broader regulatory expectation that rapidly emerging information must be shared to safeguard public health and compliance standards.